NCT05361746

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Solventum US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Class V Non-carious Cervical Dental Lesions

Interventions

Type	Name	Description
DEVICE	Scotchbond Universal Plus Adhesive	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.
DEVICE	Scotchbond Universal Adhesive	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.

Timeline

• Start date: 2022-08-18
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2022-05-05
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study