Trial Outcomes & Findings for Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative (NCT NCT03032705)
NCT ID: NCT03032705
Last Updated: 2021-12-13
Results Overview
The following properties will be evaluated using the Hickel Grading Criteria: 1. Surface luster 2. Staining - surface 3. Staining - margin 4. Color match and translucency 5. Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
From Baseline up to 2 Years After Restoration Placement
Results posted on
2021-12-13
Participant Flow
Unit = Teeth. 51 participants were randomized in this study, and a total of 102 teeth were studied. Therefore 51 participants and 102 units.
Unit of analysis: teeth
Participant milestones
| Measure |
SonicFill™ 2
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
|---|---|---|
|
Overall Study
STARTED
|
51 51
|
51 51
|
|
Overall Study
Completion of Restorations (V2)
|
45 45
|
45 45
|
|
Overall Study
COMPLETED
|
29 29
|
28 28
|
|
Overall Study
NOT COMPLETED
|
22 22
|
23 23
|
Reasons for withdrawal
| Measure |
SonicFill™ 2
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
17
|
|
Overall Study
did not quality
|
6
|
6
|
Baseline Characteristics
Clinical Evaluation of Kerr SonicFill™ 2 vs 3M ESPE Filtek™ Supreme Ultra Universal Restorative
Baseline characteristics by cohort
| Measure |
SonicFill™ 2
n=45 teeth
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
n=45 teeth
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
Total
n=90 teeth
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
44.13 years
STANDARD_DEVIATION 1.92 • n=5 Participants
|
44.13 years
STANDARD_DEVIATION 1.92 • n=7 Participants
|
44.13 years
STANDARD_DEVIATION 1.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 2 Years After Restoration PlacementPopulation: 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).
The following properties will be evaluated using the Hickel Grading Criteria: 1. Surface luster 2. Staining - surface 3. Staining - margin 4. Color match and translucency 5. Esthetic anatomical form Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Outcome measures
| Measure |
SonicFill™ 2
n=45 Teeth
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
n=45 Teeth
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
|---|---|---|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Luster at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Staining at end of study : Number of teeth rated 1
|
26 Teeth
|
22 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Marginal Staining at end of study : Number of teeth rated 3
|
1 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Color Match and Translucency at end of study : Number of teeth rated 1
|
21 Teeth
|
17 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Color Match and Translucency at end of study : Number of teeth rated 2
|
7 Teeth
|
9 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Esthetic Anatomical Form at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Luster at end of study : Number of teeth rated 1
|
25 Teeth
|
25 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Luster at end of study : Number of teeth rated 2
|
2 Teeth
|
2 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Luster at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Luster at end of study : Number of teeth rated 4
|
1 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Staining at end of study : Number of teeth rated 2
|
1 Teeth
|
3 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Staining at end of study : Number of teeth rated 3
|
1 Teeth
|
2 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Staining at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Surface Staining at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Marginal Staining at end of study : Number of teeth rated 1
|
25 Teeth
|
24 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Marginal Staining at end of study : Number of teeth rated 2
|
2 Teeth
|
3 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Marginal Staining at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Marginal Staining at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Color Match and Translucency at end of study : Number of teeth rated 3
|
0 Teeth
|
1 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Color Match and Translucency at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Color Match and Translucency at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Esthetic Anatomical Form at end of study : Number of teeth rated 1
|
27 Teeth
|
25 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Esthetic Anatomical Form at end of study : Number of teeth rated 2
|
1 Teeth
|
2 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Esthetic Anatomical Form at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Esthetic Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Esthetic Category
Esthetic Anatomical Form at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
PRIMARY outcome
Timeframe: From Baseline up to 2 Years After Restoration PlacementPopulation: 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).
The following properties will be evaluated using the Hickel Grading Criteria: 1. Fracture of material and retention 2. Marginal adaptation 3. Approximate anatomical form - contact point 4. Radio-graphic examination (when applicable) 5. Patient's view Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Outcome measures
| Measure |
SonicFill™ 2
n=45 Teeth
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
n=45 Teeth
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
|---|---|---|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Marginal Adaptation at end of study : Number of teeth rated 2
|
5 Teeth
|
2 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Marginal Adaptation at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Radiographic Examination at end of study : Number of teeth rated 2
|
0 Teeth
|
1 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Radiographic Examination at end of study : Number of teeth rated 3
|
2 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Fracture of Material and Retention at end of study : Number of teeth rated 1
|
27 Teeth
|
26 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Fracture of Material and Retention at end of study : Number of teeth rated 2
|
0 Teeth
|
1 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Fracture of Material and Retention at end of study : Number of teeth rated 3
|
1 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Fracture of Material and Retention at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Fracture of Material and Retention at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Marginal Adaptation at end of study : Number of teeth rated 1
|
23 Teeth
|
25 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Marginal Adaptation at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Marginal Adaptation at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Radiographic Examination at end of study : Number of teeth rated 1
|
26 Teeth
|
26 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Radiographic Examination at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Radiographic Examination at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Patient's View at end of study : Number of teeth rated 1
|
27 Teeth
|
27 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Patient's View at end of study : Number of teeth rated 2
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Patient's View at end of study : Number of teeth rated 3
|
1 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Patient's View at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Functional Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Functional Category
Patient's View at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
PRIMARY outcome
Timeframe: From Baseline up to 2 Years After Restoration PlacementPopulation: 45 Participants, each with 2 "units" (teeth) sampled. Due to participant drop out and replaced restorations, end-of-study categories have fewer than 45 units analyzed. 29 participants completed Visit 5 of the study - 28 teeth with SonicFill™ 2 (1 restoration replaced) and 27 teeth with Filtek™ Supreme (2 restorations replaced).
The following properties will be evaluated using the Hickel Grading Criteria: 1. Postoperative (hyper-)sensitivity and tooth vitality 2. Recurrence of caries, erosion, abfraction 3. Tooth integrity (enamel cracks, tooth fractures) 4. Adjacent mucosa Each criteria will be graded by blinded examiner in 5 point scale from 1 being excellent to 5 being clinically unacceptable
Outcome measures
| Measure |
SonicFill™ 2
n=45 Teeth
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
n=45 Teeth
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
|---|---|---|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 1
|
27 Teeth
|
27 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 2
|
1 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Tooth Integrity at end of study : Number of teeth rated 2
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Adjacent Mucosa at end of study : Number of teeth rated 2
|
1 Teeth
|
1 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 2
|
1 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Postoperative (Hyper)-Sensitivity and Tooth Vitality at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 1
|
27 Teeth
|
27 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Recurrence of Caries, Erosion, Abfraction at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Tooth Integrity at end of study : Number of teeth rated 1
|
28 Teeth
|
27 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Tooth Integrity at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Tooth Integrity at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Tooth Integrity at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Adjacent Mucosa at end of study : Number of teeth rated 1
|
27 Teeth
|
26 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Adjacent Mucosa at end of study : Number of teeth rated 3
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Adjacent Mucosa at end of study : Number of teeth rated 4
|
0 Teeth
|
0 Teeth
|
|
Change in Biological Properties: Number of Teeth, Rated 1 (Most Desirable Outcome) to 5 (Least Desirable Outcome), in Each Biological Category
Adjacent Mucosa at end of study : Number of teeth rated 5
|
0 Teeth
|
0 Teeth
|
Adverse Events
SonicFill™ 2
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Filtek™ Supreme
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SonicFill™ 2
n=45 participants at risk；n=51 participants at risk
Composite: SonicFill™ 2; Bonding Agent: Optibond XRT
SonicFill™ 2: The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
|
Filtek™ Supreme
n=45 participants at risk；n=51 participants at risk
Composite: Filtek™ Supreme Ultra Universal Restorative; Bonding Agent: Scotchbond™ Universal Adhesive
Filtek™ Supreme: The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
|
|---|---|---|
|
Product Issues
Fracture of restorations
|
4.4%
2/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
6.7%
3/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Soft tissue irritation
|
6.7%
3/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
6.7%
3/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Post operative sensitivity/Pain
|
13.3%
6/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
11.1%
5/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
|
General disorders
Pulp exposure risk, healing of non- study site, Alterantion of study site due to non-study site tx
|
6.7%
3/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
8.9%
4/45 • Through study completion, an average of 24 months.
Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
|
Additional Information
Dr Gerard Kugel
Tufts University School of Dental Medicine
Phone: (617) 636-0870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place