Trial Outcomes & Findings for In Vivo Assessment of the Tooth-Resin Composite Interface Using Optical Coherence Tomography (NCT NCT05145322)
NCT ID: NCT05145322
Last Updated: 2024-10-28
Results Overview
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline
Results posted on
2024-10-28
Participant Flow
Participants were recruited based on referral from the dental clinics of the School of Dentistry University of Minnesota and enquiries from the public upon seeing flyers pasted at the Malcolm Moos Tower. The first and last participant were enrolled on 09/23/2021 and 7/15/22 respectively.
Upon referral from the dental clinic or enquiries, potential participants were invited to attend a telemeeting where the participants were presented with the information of the trial using a MS Powerpoint slide deck. 46 participants were invited to the telemeeting and also attended an in-person screening session to determine whether they meet the inclusion criteria of the study. 36 met the inclusion criteria and were successfully enrolled into the study.
Participant milestones
| Measure |
90-degree Cavosurface Angle Cavity Margin
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Wide-bevel Cavity Margin
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
Restoration Placement
|
18
|
18
|
|
Overall Study
6-months Follow up
|
16
|
17
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
90-degree Cavosurface Angle Cavity Margin
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Wide-bevel Cavity Margin
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 2
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
34 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=36 Participants
|
|
Age, Continuous
|
32.56 years
STANDARD_DEVIATION 14.51 • n=18 Participants
|
30.17 years
STANDARD_DEVIATION 7.85 • n=18 Participants
|
31.36 years
STANDARD_DEVIATION 11.18 • n=36 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
23 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
13 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: BaselineThe World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at baseline.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
Score 3
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
Score 4
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
Score 1
|
18 Participants
|
18 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
Score 2
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
Score 5
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months Follow-upThe World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 6 months post-operative.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=17 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=16 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Score 4
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Score 1
|
17 Participants
|
16 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Score 2
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Score 3
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Score 5
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 months Follow-upThe World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 18 months post-operative.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=13 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=14 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
Score 5
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
Score 1
|
13 Participants
|
14 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
Score 2
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
Score 3
|
0 Participants
|
0 Participants
|
|
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
Score 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: BaselineThe United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline
Score A
|
18 Participants
|
18 Participants
|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline
Score B
|
0 Participants
|
0 Participants
|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline
Score C
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 months Follow-upThe United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=17 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=16 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Score A
|
17 Participants
|
16 Participants
|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Score C
|
0 Participants
|
0 Participants
|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Score B
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 months Follow-upThe United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=13 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=14 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up
Score A
|
13 Participants
|
14 Participants
|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up
Score B
|
0 Participants
|
0 Participants
|
|
Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up
Score C
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: BaselineThe World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Defect: World Dental Federation (FDI) Criteria - Baseline
100% of Score 1
|
8 Participants
|
7 Participants
|
|
Marginal Defect: World Dental Federation (FDI) Criteria - Baseline
<100% Score 1
|
10 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 6 months Follow-upThe World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=17 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=16 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up
100% Score 1
|
12 Participants
|
12 Participants
|
|
Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up
<100% Score 1
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 18 months post-operativeThe World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=13 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=14 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative
80 - 99 % Score 1
|
6 Participants
|
6 Participants
|
|
Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative
100% Score 1
|
7 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: BaselineThe United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline
Score B
|
0 Participants
|
0 Participants
|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline
Score C
|
0 Participants
|
0 Participants
|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline
Score A
|
18 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 6 months Follow-upThe United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=17 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=16 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Score C
|
0 Participants
|
0 Participants
|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Score A
|
17 Participants
|
16 Participants
|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Score B
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 18 months post-operativeThe United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=13 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=14 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative
Score A
|
13 Participants
|
14 Participants
|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative
Score B
|
0 Participants
|
0 Participants
|
|
Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative
Score C
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePresence of elevated intensity at the cavosurface angle (margins) of the restoration, which indicates presence of minor marginal defect, is computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Backscattered Intensity at the Occlusal Cavosurface Angle.
|
1.56 Percentage area
Standard Error 4.33
|
6.75 Percentage area
Standard Error 6.36
|
SECONDARY outcome
Timeframe: BaselinePresence of tooth-resin interface gap of more than 0.1 mm at the cavosurface angle (margins) of the restoration, which indicates presence of moderate marginal defect, will be computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Tooth-resin Interface Gap at the Occlusal Cavosurface Angle.
|
18.75 Percentage
Standard Error 17.63
|
14.44 Percentage
Standard Error 4.36
|
SECONDARY outcome
Timeframe: BaselinePresence of elevated backscattered intensity along the superficial 2mm depth walls of the restoration, which indicates presence of debonding, will be computed as percentage volume of the restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Outcome measures
| Measure |
Wide-bevel Cavity Margin
n=18 Participants
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 1
n=18 Participants
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls
|
7.43 Percentage
Standard Error 5.30
|
16.20 Percentage
Standard Error 4.85
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=18 participants at risk
Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
Group 2
n=18 participants at risk
Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
|
|---|---|---|
|
Surgical and medical procedures
Discomfort upon biting on the tooth with dental restoration
|
5.6%
1/18 • 18 months
The interventions in both arms are topical one-surface dental resin composite restorations and there are no systemic interventions. Hence the number of participants at risk for All-Cause Mortality and Serious Adverse Events is zero.
|
11.1%
2/18 • 18 months
The interventions in both arms are topical one-surface dental resin composite restorations and there are no systemic interventions. Hence the number of participants at risk for All-Cause Mortality and Serious Adverse Events is zero.
|
Additional Information
Hooi Pin Chew
University of Minnesota School of Dentistry
Phone: 6126256975
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place