Trial Outcomes & Findings for NCCL Direct Composite Restoration Performance With Self-Etch and Multimode Adhesives (NCT NCT02698371)
NCT ID: NCT02698371
Last Updated: 2019-09-13
Results Overview
Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)". NCCls restorations with not acceptable performance were scored as "5-Clinically poor (replacement necessary)" for clinical properties. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
24 months
Results posted on
2019-09-13
Participant Flow
Participants were recruited from the Dental School Clinic of the Faculty of Health Sciences - UFP.
54 participants were screened. Of those, 38 participants met inclusion criteria and were enrolled.
Unit of analysis: NCCLs restorations
Participant milestones
| Measure |
All Participants
Each participant is enrolled in several randomly allocated arms/groups (G1, G2, G3, G4, G5, G6) and received one to six NCCLs restorations in Premolar/molar teeth.
|
|---|---|
|
All Participants Flow
STARTED
|
38 210
|
|
All Participants Flow
COMPLETED
|
35 193
|
|
All Participants Flow
NOT COMPLETED
|
3 17
|
|
FBDC-SE (G1; Control) Arm/Group Flow
STARTED
|
35 35
|
|
FBDC-SE (G1; Control) Arm/Group Flow
COMPLETED
|
32 32
|
|
FBDC-SE (G1; Control) Arm/Group Flow
NOT COMPLETED
|
3 3
|
|
FBDC-SE-EE (G2; Control ) Arm/Group Flow
STARTED
|
35 35
|
|
FBDC-SE-EE (G2; Control ) Arm/Group Flow
COMPLETED
|
32 32
|
|
FBDC-SE-EE (G2; Control ) Arm/Group Flow
NOT COMPLETED
|
3 3
|
|
FBU-ER (G3) Arm/Group Flow
STARTED
|
35 35
|
|
FBU-ER (G3) Arm/Group Flow
COMPLETED
|
32 32
|
|
FBU-ER (G3) Arm/Group Flow
NOT COMPLETED
|
3 3
|
|
FBU-SE (G4) Arm/Group Flow
STARTED
|
35 35
|
|
FBU-SE (G4) Arm/Group Flow
COMPLETED
|
32 32
|
|
FBU-SE (G4) Arm/Group Flow
NOT COMPLETED
|
3 3
|
|
ADU-ER (G5) Arm/Group Flow
STARTED
|
35 35
|
|
ADU-ER (G5) Arm/Group Flow
COMPLETED
|
32 32
|
|
ADU-ER (G5) Arm/Group Flow
NOT COMPLETED
|
3 3
|
|
ADU-SE (G6) Arm/Group Flow
STARTED
|
35 35
|
|
ADU-SE (G6) Arm/Group Flow
COMPLETED
|
33 33
|
|
ADU-SE (G6) Arm/Group Flow
NOT COMPLETED
|
2 2
|
Reasons for withdrawal
| Measure |
All Participants
Each participant is enrolled in several randomly allocated arms/groups (G1, G2, G3, G4, G5, G6) and received one to six NCCLs restorations in Premolar/molar teeth.
|
|---|---|
|
All Participants Flow
Lost to Follow-up
|
3
|
|
FBDC-SE (G1; Control) Arm/Group Flow
Lost to Follow-up
|
3
|
|
FBDC-SE-EE (G2; Control ) Arm/Group Flow
Lost to Follow-up
|
3
|
|
FBU-ER (G3) Arm/Group Flow
Lost to Follow-up
|
3
|
|
FBU-SE (G4) Arm/Group Flow
Lost to Follow-up
|
3
|
|
ADU-ER (G5) Arm/Group Flow
Lost to Follow-up
|
3
|
|
ADU-SE (G6) Arm/Group Flow
Lost to Follow-up
|
2
|
Baseline Characteristics
Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
Baseline characteristics by cohort
| Measure |
All Participants
n=210 NCCLs restorations
Each participant is enrolled in several randomly allocated arms/groups (G1, G2, G3, G4, G5, G6) and received one to six NCCLs restorations in premolar/molar teeth.
|
|---|---|
|
Age, Continuous
FBDC-SE (G1; Control group) Arm/Group
|
50.8 years
STANDARD_DEVIATION 10.9 • n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Age, Continuous
FBDC-SE-EE (G2; Control group) Arm/Group
|
51.4 years
STANDARD_DEVIATION 10.1 • n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Age, Continuous
FBU-ER (G3) Arm/Group
|
50.6 years
STANDARD_DEVIATION 10.4 • n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Age, Continuous
FBU-SE (G4) Arm/Group
|
51.5 years
STANDARD_DEVIATION 9.8 • n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Age, Continuous
ADU-ER (G5) Arm/Group
|
50.5 years
STANDARD_DEVIATION 11.1 • n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Age, Continuous
ADU-SE (G6) Arm/Group
|
50.8 years
STANDARD_DEVIATION 10.8 • n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Sex: Female, Male
FBDC-SE (G1; Control Group) Arm/Group · Female
|
15 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBDC-SE (G1; Control Group) Arm/Group · Male
|
20 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBDC-SE-EE (G2; Control Group) Arm/Group · Female
|
16 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBDC-SE-EE (G2; Control Group) Arm/Group · Male
|
19 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBU-ER (G3) Arm/Group · Female
|
16 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBU-ER (G3) Arm/Group · Male
|
19 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBU-SE (G4) Arm/Group · Female
|
16 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
FBU-SE (G4) Arm/Group · Male
|
19 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
ADU-ER (G5) Arm/Group · Female
|
14 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
ADU-ER (G5) Arm/Group · Male
|
21 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
ADU-SE (G6) Arm/Group · Female
|
14 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Sex: Female, Male
ADU-SE (G6) Arm/Group · Male
|
21 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant sex
|
|
Systemic pathologies at baseline
FBDC-SE (G1; Control Group) Arm/Group · No
|
16 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBDC-SE (G1; Control Group) Arm/Group · yes
|
19 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBDC-SE-EE (G2; Control group) Arm/Group · No
|
14 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBDC-SE-EE (G2; Control group) Arm/Group · yes
|
21 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBU-ER (G3) Arm/Group · No
|
15 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBU-ER (G3) Arm/Group · yes
|
20 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBU-SE (G4) Arm/Group · No
|
14 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
FBU-SE (G4) Arm/Group · yes
|
21 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
ADU-ER (G5) Arm/Group · No
|
16 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
ADU-ER (G5) Arm/Group · yes
|
19 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
ADU-SE (G6) Arm/Group · No
|
16 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Systemic pathologies at baseline
ADU-SE (G6) Arm/Group · yes
|
19 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant systemic pathologies (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBDC-SE (G1; Control Group) Arm/Group · Very good
|
23 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBDC-SE (G1; Control Group) Arm/Group · Good
|
12 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBDC-SE-EE (G2; Control group) Arm/Group · Very good
|
25 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBDC-SE-EE (G2; Control group) Arm/Group · Good
|
10 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBU-ER (G3) Arm/Group · Very good
|
25 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBU-ER (G3) Arm/Group · Good
|
10 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBU-SE (G4) Arm/Group · Very good
|
24 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
FBU-SE (G4) Arm/Group · Good
|
11 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
ADU-ER (G5) Arm/Group · Very good
|
23 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
ADU-ER (G5) Arm/Group · Good
|
12 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
ADU-SE (G6) Arm/Group · Very good
|
22 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Oral hygiene at baseline
ADU-SE (G6) Arm/Group · Good
|
13 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant oral hygiene (very good/good) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBDC-SE (G1; Control Group) Arm/Group · No
|
30 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBDC-SE (G1; Control Group) Arm/Group · Yes
|
5 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBDC-SE-EE (G2; Control group) Arm/Group · No
|
30 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBDC-SE-EE (G2; Control group) Arm/Group · Yes
|
5 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBU-ER (G3) Arm/Group · No
|
30 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBU-ER (G3) Arm/Group · Yes
|
5 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBU-SE (G4) Arm/Group · No
|
30 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
FBU-SE (G4) Arm/Group · Yes
|
5 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
ADU-ER (G5) Arm/Group · No
|
29 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
ADU-ER (G5) Arm/Group · Yes
|
6 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
ADU-SE (G6) Arm/Group · No
|
30 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Smoking habits at baseline
ADU-SE (G6) Arm/Group · Yes
|
5 NCCLs restorations
n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant smoking habits (yes/no) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Daily cigarettes (NCCLs restorations in smoker participants) at baseline
FBDC-SE (G1; Control Group) Arm/Group
|
2.1 cigarettes per day
STANDARD_DEVIATION 5.6 • n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant Daily cigarettes (NCCLs restorations in smoker participants) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Daily cigarettes (NCCLs restorations in smoker participants) at baseline
FBDC-SE-EE (G2; Control group) Arm/Group
|
1.6 cigarettes per day
STANDARD_DEVIATION 4.7 • n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant Daily cigarettes (NCCLs restorations in smoker participants) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Daily cigarettes (NCCLs restorations in smoker participants) at baseline
FBU-ER (G3) Arm/Group
|
1.6 cigarettes per day
STANDARD_DEVIATION 4.7 • n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant Daily cigarettes (NCCLs restorations in smoker participants) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Daily cigarettes (NCCLs restorations in smoker participants) at baseline
FBU-SE (G4) Arm/Group
|
1.6 cigarettes per day
STANDARD_DEVIATION 4.7 • n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant Daily cigarettes (NCCLs restorations in smoker participants) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Daily cigarettes (NCCLs restorations in smoker participants) at baseline
ADU-ER (G5) Arm/Group
|
2.2 cigarettes per day
STANDARD_DEVIATION 5.6 • n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant Daily cigarettes (NCCLs restorations in smoker participants) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
Daily cigarettes (NCCLs restorations in smoker participants) at baseline
ADU-SE (G6) Arm/Group
|
1.8 cigarettes per day
STANDARD_DEVIATION 5.3 • n=35 NCCLs restorations • NCCLs restorations per arm/group distribution, according to the participant Daily cigarettes (NCCLs restorations in smoker participants) at baseline. Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBDC-SE (G1; Control Group) Arm/Group · Pre-molar tooth
|
29 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBDC-SE (G1; Control Group) Arm/Group · Molar tooth
|
6 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBDC-SE-EE (G2; Control group) Arm/Group · Pre-molar tooth
|
32 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBDC-SE-EE (G2; Control group) Arm/Group · Molar tooth
|
3 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBU-ER (G3) Arm/Group · Pre-molar tooth
|
32 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBU-ER (G3) Arm/Group · Molar tooth
|
3 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBU-SE (G4) Arm/Group · Pre-molar tooth
|
27 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
FBU-SE (G4) Arm/Group · Molar tooth
|
8 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
ADU-ER (G5) Arm/Group · Pre-molar tooth
|
30 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
ADU-ER (G5) Arm/Group · Molar tooth
|
5 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
ADU-SE (G6) Arm/Group · Pre-molar tooth
|
26 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Tooth Type
ADU-SE (G6) Arm/Group · Molar tooth
|
9 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE (G1; Control Group) Arm/Group · Degree 1
|
29 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE (G1; Control Group) Arm/Group · Degree 2
|
4 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE (G1; Control Group) Arm/Group · Degree 3
|
0 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE (G1; Control Group) Arm/Group · Degree 4
|
2 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE-EE (G2; Control group) Arm/Group · Degree 1
|
24 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE-EE (G2; Control group) Arm/Group · Degree 2
|
7 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE-EE (G2; Control group) Arm/Group · Degree 3
|
1 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBDC-SE-EE (G2; Control group) Arm/Group · Degree 4
|
3 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-ER (G3) Arm/Group · Degree 1
|
26 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-ER (G3) Arm/Group · Degree 2
|
5 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-ER (G3) Arm/Group · Degree 3
|
0 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-ER (G3) Arm/Group · Degree 4
|
4 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-SE (G4) Arm/Group · Degree 1
|
20 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-SE (G4) Arm/Group · Degree 2
|
7 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-SE (G4) Arm/Group · Degree 3
|
3 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
FBU-SE (G4) Arm/Group · Degree 4
|
5 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-ER (G5) Arm/Group · Degree 1
|
23 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-ER (G5) Arm/Group · Degree 2
|
5 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-ER (G5) Arm/Group · Degree 3
|
4 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-ER (G5) Arm/Group · Degree 4
|
3 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-SE (G6) Arm/Group · Degree 1
|
24 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-SE (G6) Arm/Group · Degree 2
|
7 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-SE (G6) Arm/Group · Degree 3
|
0 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCLs Sclerotic Dentin Degree
ADU-SE (G6) Arm/Group · Degree 4
|
4 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBDC-SE (G1; Control Group) Arm/Group · Acute (<45º)
|
13 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBDC-SE (G1; Control Group) Arm/Group · Acute-to-Right (45º- 90º)
|
9 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBDC-SE (G1; Control Group) Arm/Group · Obtuse (>90º)
|
13 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBDC-SE-EE (G2; Control group) Arm/Group · Acute (<45º)
|
17 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBDC-SE-EE (G2; Control group) Arm/Group · Acute-to-Right (45º- 90º)
|
11 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBDC-SE-EE (G2; Control group) Arm/Group · Obtuse (>90º)
|
7 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBU-ER (G3) Arm/Group · Acute (<45º)
|
14 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBU-ER (G3) Arm/Group · Acute-to-Right (45º- 90º)
|
11 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBU-ER (G3) Arm/Group · Obtuse (>90º)
|
10 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBU-SE (G4) Arm/Group · Acute (<45º)
|
14 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBU-SE (G4) Arm/Group · Acute-to-Right (45º- 90º)
|
9 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
FBU-SE (G4) Arm/Group · Obtuse (>90º)
|
12 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
ADU-ER (G5) Arm/Group · Acute (<45º)
|
15 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
ADU-ER (G5) Arm/Group · Acute-to-Right (45º- 90º)
|
8 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
ADU-ER (G5) Arm/Group · Obtuse (>90º)
|
12 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
ADU-SE (G6) Arm/Group · Acute (<45º)
|
11 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
ADU-SE (G6) Arm/Group · Acute-to-Right (45º- 90º)
|
12 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
|
NCCls Cavity Geometry (Internal angle shape, degree º)
ADU-SE (G6) Arm/Group · Obtuse (>90º)
|
12 NCCLs restorations
n=35 NCCLs restorations • Each participant is enrolled in several arms and received 1 to 6 NCCLs restorations.
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed, using FDI criteria, at 24 month recall.
Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "1-Clinically excellent/ very good", "2-Clinically good (after correction, very good)", "3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth)", "4-Clinically unsatisfactory (repair for prophylactic reasons)". NCCls restorations with not acceptable performance were scored as "5-Clinically poor (replacement necessary)" for clinical properties. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Esthetic-FDI- 24 Month · Acceptance Performance
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Esthetic-FDI- 24 Month · Not Acceptance Performance
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Esthetic-FDI- 24 Month · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Functional-FDI- 24 Month · Acceptance Performance
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Functional-FDI- 24 Month · Not Acceptance Performance
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Functional-FDI- 24 Month · NCCLs restorations missing
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-FDI-24 Month (included in Functional Not Acceptance Performance count of Units)
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-FDI-24 Month (included in Functional Not Acceptance Performance count of Units)
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-FDI-24 Month (included in Functional Not Acceptance Performance count of Units)
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-FDI-24 Month (included in Functional Not Acceptance Performance count of Units)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Biological-FDI- 24 Month · Acceptance Performance
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Biological-FDI- 24 Month · Not Acceptance Performance
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Biological-FDI- 24 Month · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed, using USPHS criteria, at 24 month recall.
Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as "Alfa" and "Bravo". NCCls restorations with not acceptable performance were scored as "Charlie" for Esthetic properties, for Retention criteria and for Biological properties, and also scored "Delta" for Marginal Adaptation criteria. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Esthetic-USPHS- 24 Month · Acceptance Performance
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Esthetic-USPHS- 24 Month · Not Acceptance Performance
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Esthetic-USPHS- 24 Month · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Functional-USPHS- 24 Month · Acceptance Performance
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Functional-USPHS- 24 Month · Not Acceptance Performance
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Functional-USPHS- 24 Month · NCCLs restorations missing
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-USPHS-24 Month (included in Functional Not Acceptance Performance count of Units)
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-USPHS-24 Month (included in Functional Not Acceptance Performance count of Units)
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-USPHS-24 Month (included in Functional Not Acceptance Performance count of Units)
|
NA NCCLs restorations
NCCLs restorations missing due to retention lost were classified as Not Acceptance Performance for Functional-USPHS-24 Month (included in Functional Not Acceptance Performance count of Units)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Biological-USPHS- 24 Month · Acceptance Performance
|
28 NCCLs restorations
|
28 NCCLs restorations
|
28 NCCLs restorations
|
27 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Biological-USPHS- 24 Month · Not Acceptance Performance
|
1 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
|
Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Biological-USPHS- 24 Month · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Esthetic, Functional and Biological parameters, using FDI and USPHS criteria, at 24 month recall.
FDI or USPHS criteria evaluation outcomes for Esthetic, Functional and Biological parameters, at 24th month follow-up were expressed as the number os NCCLs With Clinical Acceptance for each parameter. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Functional · NCCLs restorations Not Acceptable
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Esthetic · NCCLs restorations Acceptable
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Esthetic · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Esthetic · NCCLs restorations Not Acceptable
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Esthetic · NCCLs restorations Acceptable
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Esthetic · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Esthetic · NCCLs restorations Not Acceptable
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Functional · NCCLs restorations Acceptable
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Functional · NCCLs restorations missing
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for FDI-Functional category (included in NCCLs restorations FDI-Functional Count of Units)
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for FDI-Functional category (included in NCCLs restorations FDI-Functional Count of Units)
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for FDI-Functional category (included in NCCLs restorations FDI-Functional Count of Units)
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for FDI-Functional category (included in NCCLs restorations FDI-Functional Count of Units)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Functional · NCCLs restorations Acceptable
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Functional · NCCLs restorations missing
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for USPHS-Functional category (included in NCCLs restorations USPHS-Functional Count of Units)
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for USPHS-Functional category (included in NCCLs restorations USPHS-Functional Count of Units)
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for USPHS-Functional category (included in NCCLs restorations USPHS-Functional Count of Units)
|
NA NCCLs restorations
NCCLs restorations not observed due to retention/marginal integrity lost were scored as Not Acceptable for USPHS-Functional category (included in NCCLs restorations USPHS-Functional Count of Units)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Functional · NCCLs restorations Not Acceptable
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Biological · NCCLs restorations Acceptable
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Biological · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
FDI-Biological · NCCLs restorations Not Acceptable
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Biological · NCCLs restorations Acceptable
|
28 NCCLs restorations
|
28 NCCLs restorations
|
28 NCCLs restorations
|
27 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Biological · NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.
USPHS-Biological · NCCLs restorations Not Acceptable
|
1 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Surface Luster, using FDI criteria, at 24 month recall.
Surface Luster Clinical Acceptance was expressed as the number of NCCls restorations classified as "(11)-Luster comparable to enamel", "(12)-Slightly dull, not noticeable from speaking distance", "(13)-Dull surface but acceptable if covered with film of saliva", "(14)- Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary". NCCls restorations with not acceptable Surface Luster were classified as "(15)-Quite rough, unacceptable plaque retentive surface". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score (11)
|
28 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
32 NCCLs restorations
|
|
Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score (12)
|
1 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
|
Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score (13)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score (14)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score (15)
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Staining Margin, using FDI criteria, at 24 month recall.
Staining Margin Clinical Acceptance was expressed as the number of NCCls restorations classified as "(21)-No surface staining", "(22)-Minor staining, easily removable", "(23)-Moderate surface staining, also present on other teeth, not aesthetically unacceptable", "(24)-Surface staining present on the restoration and is unacceptable; major intervention necessary for improvement". NCCls restorations with not acceptable Staining Margin were classified as "(25)-Severe staining and/or subsurface staining (generalized or localized); not accessible for intervention". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 21
|
26 NCCLs restorations
|
29 NCCLs restorations
|
28 NCCLs restorations
|
28 NCCLs restorations
|
30 NCCLs restorations
|
30 NCCLs restorations
|
|
Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 22
|
3 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
|
Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 23
|
0 NCCLs restorations
|
1 NCCLs restorations
|
1 NCCLs restorations
|
1 NCCLs restorations
|
1 NCCLs restorations
|
2 NCCLs restorations
|
|
Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 24
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
|
Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 25
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Colour Stability and Translucency, using FDI criteria, at 24 month recall.
Colour Stability and Translucency Clinical Acceptance was expressed as the number of NCCls restorations classified as "(31)-Good colour match no difference in shade and translucency", "(32)-Minor deviations", "(33)-Clear deviation but acceptable. Does not affect aesthetics", "(34)-(Localised) clinically unsatisfactory but can be corrected by repair". NCCls restorations with not acceptable Colour Stability and Translucency were classified as "(35)-Unacceptable. Replacement necessary". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 31
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
|
Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 32
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
|
Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 33
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 34
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 35
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Fractures and Retention, using FDI criteria, at 24 month recall.
Fractures and Retention Clinical Acceptance was expressed as the number of NCCls restorations classified as "(41)-Restoration retained, no fractures/cracks", "(42)-Small hairline crack", "(43)-Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact", "(44)-Chipping fractures which damage marginal quality or proximal contacts; bulk fractures with or without partial loss(less than half of the restoration)". NCCls restorations with not acceptable Fractures and Retention were classified "(45)-Partial or complete loss of restoration".
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 41
|
29 NCCLs restorations
|
29 NCCLs restorations
|
29 NCCLs restorations
|
27 NCCLs restorations
|
32 NCCLs restorations
|
32 NCCLs restorations
|
|
Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 42
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
|
Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 43
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 44
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 45
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Marginal Adaptation, using FDI criteria, at 24 month recall.
Marginal Adaptation Clinical Acceptance was expressed as the number of NCCls restorations classified as "(51)-Harmonious outline, no gaps, no discoloration", "(52)-Marginal gap (50 µm) or Small marginal fracture removable by polishing", "(53)-Gap\< 150 µm not removable or Severe small enamel or dentin fractures", "(54)- Gap\> 250 µm or dentine exposed or Chip fracture damaging margins or Notable enamel or dentine wall fracture", "(55)-Filling is loose but in situ". NCCLs restorations not observed due to retention lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 51
|
21 NCCLs restorations
|
29 NCCLs restorations
|
24 NCCLs restorations
|
24 NCCLs restorations
|
27 NCCLs restorations
|
27 NCCLs restorations
|
|
Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 52
|
5 NCCLs restorations
|
0 NCCLs restorations
|
3 NCCLs restorations
|
3 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
|
Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 53
|
3 NCCLs restorations
|
1 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
4 NCCLs restorations
|
|
Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 54
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 55
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Postoperative Hypersensibility, Tooth Vitality, using FDI criteria, at 24 month recall.
Postoperative Hypersensibility, Tooth Vitality Clinical Acceptance was expressed as the number of NCCls restorations classified as "(61)-No hypersensitivity, normal vitality", "(62)-Low hypersensitivity for a limited period of time, normal vitality", "(63)-Premature/slightly more intense or Delayed/weak sensitivity; no subjective complaints, no treatment needed", "(64)-Premature/very intense or Extremely delayed/weak with subjective complaints or Negative sensitivity intervention necessary but not replacement". NCCls restorations with not acceptable Postoperative Hypersensibility, Tooth Vitality criteria were classified as (65)-Very intense, acute pulpitis or no vital; Endodontic treatment is necessary and restoration has to be replaced".NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 61
|
29 NCCLs restorations
|
28 NCCLs restorations
|
29 NCCLs restorations
|
28 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
|
Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 62
|
0 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
2 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
|
Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 63
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 64
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 65
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Recurrence of Caries, Erosion, Abfraction, using FDI criteria, at 24 month recall.
Recurrence of Caries, Erosion, Abfraction Clinical Acceptance was expressed as the number of NCCls restorations classified as "(71)-No secondary or primary caries", "(72)-Very small and localized. No operative treatment required", "(73)-Larger areas of: Demineralisation or Erosion or Abrasion/abfraction in dentine, localized and accessible and can be repaired", "(74)-Caries with cavitation or Erosion in dentine or Abrasion/abfraction in dentine Localized and accessible and can be repaired". NCCls restorations with not acceptable Recurrence of Caries, Erosion, Abfraction criteria were classified as "(75)-Deep secondary caries or exposed dentine that is not accessible for repair of restoration". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 71
|
29 NCCLs restorations
|
29 NCCLs restorations
|
29 NCCLs restorations
|
29 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 72
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 73
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 74
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 75
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Tooth Integrity (enamel cracks), using FDI criteria, at 24 month recall.
Tooth Integrity (enamel cracks) Clinical Acceptance was expressed as the number of NCCls restorations classified as "(81)-Complete integrity", "(82)-Small margin enamel(\<150 µm) or Hairline crack in enamel (\<150 µm not probable)", "(83)-Enamel split(\<250 µm) or Crack\< 250 µm, no adverse effects", "(84)-Major enamel split (gap\>250 µm or dentine or base exposed) or Crack\>250 µm (probe penetrates)". NCCls restorations with not acceptable Tooth Integrity (enamel cracks) criteria were classified as "(85)-Cusp or tooth fracture". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 81
|
26 NCCLs restorations
|
30 NCCLs restorations
|
27 NCCLs restorations
|
26 NCCLs restorations
|
28 NCCLs restorations
|
32 NCCLs restorations
|
|
Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 82
|
3 NCCLs restorations
|
0 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
3 NCCLs restorations
|
1 NCCLs restorations
|
|
Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 83
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
|
Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 84
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
Score 85
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Surface Staining, using USPHS criteria, at 24 month recall.
Surface Staining Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)- No staining in the restoration and/or the tooth" or "(Bravo)-Slight staining in the restoration and/or the tooth". NCCls restorations with not acceptable Surface Staining were classified as "(Charlie)-The staining penetrated in the restoration and/or the tooth in a pulpal direction". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Alfa
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Bravo
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Charlie
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Marginal Discoloration, using USPHS criteria, at 24 month recall.
Marginal Discoloration Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-No discoloration along the margin between the restoration and adjacent tooth" or "(Bravo)-Slight discoloration along the margin between the restoration and the adjacent tooth (removable, usually localized)". NCCls restorations with not acceptable Marginal Discoloration were classified as "(Charlie)-Deep staining cannot be polished away". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Alfa
|
25 NCCLs restorations
|
28 NCCLs restorations
|
27 NCCLs restorations
|
27 NCCLs restorations
|
29 NCCLs restorations
|
31 NCCLs restorations
|
|
Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Bravo
|
4 NCCLs restorations
|
2 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
|
Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Charlie
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Color Match, using USPHS criteria, at 24 month recall.
Color Match Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-Restoration matches the adjacent tooth structure in color and translucency" or "(Bravo)-Light mismatch in color, shade or translucency between the restoration and the adjacent tooth". NCCls restorations with not acceptable Color Match were classified as "(Charlie)-The mismatch in color and translucency is outside the acceptable range of tooth color and translucency". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Alfa
|
29 NCCLs restorations
|
30 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
31 NCCLs restorations
|
33 NCCLs restorations
|
|
Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Bravo
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
|
Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Charlie
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Retention, using USPHS criteria, at 24 month recall.
Retention Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-Retained" or "(Bravo)-Partially retained". NCCls restorations with not acceptable Retention were classified as "(Charlie)-Missing".
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Alfa
|
29 NCCLs restorations
|
29 NCCLs restorations
|
29 NCCLs restorations
|
29 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Bravo
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Charlie
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Marginal Integrity, using USPHS criteria, at 24 month recall.
Marginal Integrity Clinical Acceptance was expressed as the number of NCCls restorations classified as "(Alfa)-No visible evidence of crevice along the margin", "(Bravo)-Visible evidence of a crevice along the margin into which the explorer will penetrate"or "(Charlie)-Dentin or the base is exposed". NCCls restorations with not acceptable Marginal Integrity were classified as "(Delta)-Restoration is fractured, mobile or missing".
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Alfa
|
23 NCCLs restorations
|
28 NCCLs restorations
|
24 NCCLs restorations
|
24 NCCLs restorations
|
27 NCCLs restorations
|
29 NCCLs restorations
|
|
Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Bravo
|
6 NCCLs restorations
|
2 NCCLs restorations
|
5 NCCLs restorations
|
5 NCCLs restorations
|
5 NCCLs restorations
|
4 NCCLs restorations
|
|
Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Charlie
|
0 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
Delta
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Postoperative Sensitivity, using USPHS criteria, at 24 month recall.
Postoperative Sensitivity Clinical Acceptance was expressed as the number of NCCls restorations classified as "(A)-No evidence of postoperative sensitivity". NCCls restorations with not acceptable Postoperative Sensitivity were classified as "(B)-Experience of postoperative sensitivity. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
(A)-No evidence
|
28 NCCLs restorations
|
28 NCCLs restorations
|
29 NCCLs restorations
|
27 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
|
Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
(B)-Experience
|
1 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
|
Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Secondary Caries, using USPHS criteria, at 24 month recall.
Secondary Caries Clinical Acceptance was expressed as the number of NCCls restorations classified as "(A)-No evidence of caries". NCCls restorations with not acceptable Secondary Caries criteria were classified as "(B)-Evidence of caries along the margin of the restoration. NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
(A)-No evidence
|
29 NCCLs restorations
|
29 NCCLs restorations
|
29 NCCLs restorations
|
28 NCCLs restorations
|
32 NCCLs restorations
|
33 NCCLs restorations
|
|
Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
(B)-Evidence
|
0 NCCLs restorations
|
1 NCCLs restorations
|
0 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
|
Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Gingival Bleeding, using USPHS criteria, at 24 month recall.
Gingival Bleeding Clinical Acceptance was expressed as the number of NCCls restorations classified as "(A)-No evidence of gingival bleeding adjacent to Class II restoration". NCCls restorations with not acceptable Gingival Bleeding criteria were classified as "(B)-Evidence of gingival bleeding adjacent to Class II restoration". NCCLs restorations not observed due to retention/marginal integrity lost were scored as "missing" for other categories.
Outcome measures
| Measure |
FBDC-SE (G1; Control Group)
n=32 NCCLs restorations
Futurabond®DC (FBDC) adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBDC rubbered in enamel and dentine for 20s, then dryed for at least 5s with an air syringe and then light-cured.
|
FBDC-SE-EE (G2; Control Group)
n=32 NCCLs restorations
FBDC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) in NCCls cavities randomly assigned to premolar or molar teeth: Enamel etched with 36% phosphoric acid for 30s and then removed with water during 1 minute; finally, FBDC applied by SE mode, simultaneously in dentin and enamel and light-cured.
|
FBU-ER (G3)
n=32 NCCLs restorations
FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
FBU-SE (G4)
n=32 NCCLs restorations
FBU adhesive by self-etch (SE) mode in NCCls cavities randomly assigned to premolar or molar teeth: FBU rubbered in enamel and dentine for 20s, then dyed for at least 5s and then, light-cured.
|
ADU-ER (G5)
n=32 NCCLs restorations
Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode in NCCls cavities randomly assigned to premolar or molar teeth: Etching of dental tissues with 36% phosphoric acid (15s in dentin and 30s in enamel) and then rinse with water for 1 min; Dryed off the excess moisture with a gentle stream of air. ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
ADU-SE (G6)
n=33 NCCLs restorations
ADU adhesive by self-etch (SE) mode in NCCLs cavities randomly assigned to premolar or molar teeth: ADU scrubbled in enamel and dentine for 20s, then dyed for at least 5s and then light-cured.
|
|---|---|---|---|---|---|---|
|
Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
(A)-No evidence
|
28 NCCLs restorations
|
29 NCCLs restorations
|
28 NCCLs restorations
|
29 NCCLs restorations
|
30 NCCLs restorations
|
32 NCCLs restorations
|
|
Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
(B)-Evidence
|
1 NCCLs restorations
|
1 NCCLs restorations
|
1 NCCLs restorations
|
1 NCCLs restorations
|
2 NCCLs restorations
|
1 NCCLs restorations
|
|
Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall
NCCLs restorations missing
|
3 NCCLs restorations
|
2 NCCLs restorations
|
3 NCCLs restorations
|
2 NCCLs restorations
|
0 NCCLs restorations
|
0 NCCLs restorations
|
Adverse Events
FBDC-SE (G1; Control Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FBDC-SE-EE (G2; Control Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FBU-ER (G3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FBU-SE (G4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADU-ER (G5)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADU-SE (G6)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Patricia Manarte-Monteiro; Associate Professor
University Fernando Pessoa
Phone: +351 225 071 300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place