Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs

Study Overview
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Brief Summary
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This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus and Scotchbond Universal adhesives when used with Filtek restorative. The study will enroll a minimum of 46 Subjects with Class-V non-carious cervical lesion (NCCL) on a minimum of two teeth.

Detailed Description
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This is a prospective, controlled, within-subject, randomized, single-center study that will enroll Subjects scheduled to undergo Class-V NCCL restorations on 2 or 4 teeth treated in pairs according to lesion depth. The study will enroll a minimum of 46 Subjects from a single site located in Birmingham, AL, USA. Each study tooth will be restored using only one type of adhesive, either SBU+ or SBU, and Filtek restorative. Any teeth needing treatment that are not included in the study will be treated by the dentist using the standard of care. Subjects will be seen during screening (≤21 days before the restoration procedure), on the day of the restoration procedure, 7 days (± 3 days) after restoration (remote visit for subject self-assessment of baseline hypersensitivity), and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restorations. Study teeth will be assessed for selected endpoints based partly on FDI World Dental Federation criteria. Subjects may participate in additional unscheduled visits as required during the study if evaluation of any study tooth is required outside of the scheduled study visits. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days). To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. All assessments will be performed by 2 dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit before the Subject leaves the visit. The consensus assessments will be entered into the Case Report Form (CRF).

Official Title
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Clinical Performance of a New Dental Adhesive, 3M™ Scotchbond™ Universal Plus Adhesive, Compared to 3M™ Scotchbond™ Universal Adhesive When Used With 3M™ Filtek™ Universal Restorative to Restore Class V Non-carious Cervical Lesions

Conditions
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Class V Non-carious Cervical Dental Lesions

Intervention / Treatment
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* Device: Scotchbond Universal Plus Adhesive
* Device: Scotchbond Universal Adhesive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects may be included that meet the following criteria: Subject is at least 18 years of age at the time of consent Subject is able to provide their own informed consent Subject has a minimum of two teeth that: have non-carious Class V lesions that are at least 1.5 mm deep are not devitalized have not undergone root canal treatment Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents Subject is able and willing to return for all scheduled study visits Subject meets the Level-I or Level-II classification criteria of the American Society of Anesthesiologists (ASA) Physical Status Classification System For Dental Patient Care Exclusion Criteria: Subjects may not be included that meet any of the following criteria: Subject has any of the following: rampant caries chronic periodontitis salivary gland dysfunction Subject is unable, for any reason, to tolerate the procedure time required to place the restorations Subject has unacceptable oral hygiene (eg, chronic moderate to heavy plaque accumulation along the gumline) Subject has known sensitivity to the study product components (ie, acrylate) Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will have either two restorations (two teeth) or four restorations (four teeth) performed at the beginning of the study, with each tooth restoration using only one type of adhesive. Study teeth will be paired according to lesion depth and randomized to treatment in a 1:1 ratio with at least half of the teeth (ie, 1 tooth for Subjects with 2 eligible teeth or 2 teeth for Subjects with 4 eligible teeth) randomized to undergo restoration(s) using Scotchbond Universal Plus Adhesive (SBU+ Treatment group) and the other half of the teeth undergoing restoration(s) using Scotchbond Universal Adhesive (SBU Control group).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBU+ Treatment Group<br>Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive . | Device: Scotchbond Universal Plus Adhesive<br>* Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group will undergo restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material.<br>|
| Active Comparator: SBU Control Group<br>Either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs will undergo restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive. | Device: Scotchbond Universal Adhesive<br>* Eligible teeth with Class-V NCCLs randomized to the SBU Control group will undergo restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration Retention | proportion of Subjects with partial or complete loss of the restoration materials | 24 months | 
| Marginal Adaptation | Marginal adaptation / marginal integrity of restorations scored on scale of 1-5 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration Retention | proportion of Subjects with partial or complete loss of the restoration material | baseline, 6 months, 12 months | 
| Marginal Adaptation | Marginal adaptation / marginal integrity of restorations scored on scale of 1-5 | baseline, 6 months, 12 months | 
| Fracture of Restorative Material | Fractures on study teeth scored on a scale of 1-4 | baseline, 6 months, 12 months, 24 months | 
| Secondary Caries | Incidence of secondary caries of study teeth scored on scale 1-5 | baseline, 6 months, 12 months, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scotchbond Universal, composite resins, dental adhesives, noncarious lesions, abfraction lesions, bonding, dental, clinical study, Scotchbond Universal plus, Filtek, dental materials