Trial Outcomes & Findings for Esthetics of Dental Composite and Adhesive System (NCT NCT03716349)
NCT ID: NCT03716349
Last Updated: 2026-05-01
Results Overview
For each system, the Visual Analog Scale of 0-100 with 0 being a poor result and 100 being an excellent result will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.
COMPLETED
NA
36 participants
5 years
2026-05-01
Participant Flow
Unit of analysis: teeth
Participant milestones
| Measure |
System A
Tokuyama Universal Single Component Self-Etching 1-step adhesive system with Tokuyama supra-nanofilled dental composite was randomly assigned to the left or right side maxillary tooth in a split-mouth randomized design.
|
System B
ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra, nanofilled dental composite (3M) was randomly assigned to the left or right side maxillary tooth in a split-mouth randomized design.
|
|---|---|---|
|
Overall Study
STARTED
|
36 36
|
36 36
|
|
Overall Study
COMPLETED
|
11 11
|
12 12
|
|
Overall Study
NOT COMPLETED
|
25 25
|
24 24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Randomization of Participants' Teeth to System A or System B
n=36 Participants
1 Participant has 2 teeth that were enrolled in the study. System A was randomly assigned to one of the teeth, and System B was randomly assigned to the other tooth in this split-mouth model study design.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: The discrepancy is that for System A, one participant needed to have treatment performed on a tooth that had been assigned to System A. Therefore, this tooth needed to be removed from the study, which resulted in a decrease by one in the number of participants analyzed for system A and the number of teeth analyzed for System A.
For each system, the Visual Analog Scale of 0-100 with 0 being a poor result and 100 being an excellent result will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.
Outcome measures
| Measure |
System A
n=11 Teeth
Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. Teeth assessment and clinical assessment at periodic timepoints.
|
System B
n=12 Teeth
ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. Teeth assessment and clinical assessment at periodic timepoints.
|
|---|---|---|
|
Patient Satisfaction of the Restoration's Appearance (Esthetics) Using the Visual Analog Scale
|
85 units on a scale
Standard Deviation 26
|
79 units on a scale
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The discrepancy is that for System A, one participant needed to have treatment performed on a tooth that had been assigned to System A. Therefore, this tooth needed to be removed from the study, which resulted in a decrease by one in the number of participants analyzed for system A and the number of teeth analyzed for System A.
For each system, the Verbal Rating Scale with 1 being a "Not at all Satisfied", 2 being "Somewhat Satisfied", 3 being "Satisfied" and 4 being "Very Satisfied" will be used for the subject to voluntarily assess their satisfaction with each restoration's appearance.
Outcome measures
| Measure |
System A
n=11 Participants
Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system w/Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan), informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. Teeth assessment and clinical assessment at periodic timepoints.
|
System B
n=12 Participants
ScotchBond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M) will randomly be applied to the other tooth informed consent signed, release of medical information signed, oral exam, health Questionnaire completed and/or updated, xray obtained if needed, pulp vitality testing, Tooth shade determination, photos of teeth, local and/or topical anesthetic applied as necessary, rubber dam isolation, tooth surface cleaned, cavity preparation performed as usual for caries removal, Enamel margins beveled, infinite invisible margins created, adhesive systems applied, dental composite placed, shade selection using Easy Shade 5. Light curing, restoration will be contoured and polished. Teeth assessment and clinical assessment at periodic timepoints.
|
|---|---|---|
|
Patient Satisfaction of the Restoration Appearance (Esthetics) Using the Verbal Rating Scale
|
3.54 units on a scale
Standard Deviation 0.93
|
3.16 units on a scale
Standard Deviation 1.02
|
Adverse Events
System A
System B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Erica Teixeira
University of Iowa College of Dentistry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place