Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs (SBU+ClassV)

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

This is a prospective, controlled, within-subject, randomized, single-center study comparing Scotchbond Universal Plus (SBU+) and Scotchbond Universal (SBU) adhesives when used with Filtek restorative. The study will enroll Subjects scheduled to undergo Class-V non-carious cervical lesion (NCCL) restorations.

Study Overview

• Status: Completed
• Conditions: Class V Non-carious Cervical Dental Lesions
• Intervention / Treatment: Device: Scotchbond Universal Plus Adhesive; Device: Scotchbond Universal Adhesive

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. Enough subjects will be enrolled from a single site located in New Orleans, Louisiana, USA to perform a minimum of 110 restorations (estimated 38 subjects). Each study tooth will be restored using only one type of adhesive, either SBU+ or SBU, and Filtek restorative following manufacturer's directions using the "Total Etch/Etch and Rinse Procedure". 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 (Fédération Dentaire Internationale) 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. 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).

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Louisiana State University HSC-Health, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Subjects may be included that meet the following criteria:

1. Subject is at least 18 years of age at the time of consent
2. Subject is able to provide their own informed consent

3. 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
4. Subject has an Approximal Plaque Index score ≤ 40% as assessed via explorer and without the use of plaque-disclosing agents
5. Subject is able and willing to return for all scheduled study visits
6. 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:

1. Subject has any of the following:

   • rampant caries
   • chronic periodontitis
   • salivary gland dysfunction
2. Subject is unable, for any reason, to tolerate the procedure time required to place the restorations
3. Subject has unacceptable oral hygiene (eg, chronic moderate to heavy plaque accumulation along the gumline)
4. Subject has known sensitivity to the study product components (ie, acrylate)
5. Subject is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBU+ Treatment Group; In a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive .	Device: Scotchbond Universal Plus Adhesive; Eligible teeth with Class-V NCCLs randomized to the SBU+ treatment group underwent restoration(s) using Scotchbond Universal Plus (SBU+) Adhesive using total-etch mode and Filtek Universal Restorative material.
Active Comparator: SBU Control Group; In a split-mouth design, either 1 tooth (for Subjects with 2 eligible teeth) or 2 teeth (for Subjects with 4 eligible teeth) with Class-V NCCLs underwent restoration(s) using the predicate device, Scotchbond Universal (SBU) Adhesive.	Device: Scotchbond Universal Adhesive; Eligible teeth with Class-V NCCLs randomized to the SBU Control group underwent restoration(s) using Scotchbond Universal Plus (SBU) Adhesive using total-etch mode and Filtek Universal Restorative material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of Restorative Material	The percentage of restorations with partial or complete loss of the restorative materials.	24 months post-restoration
Marginal Adaptation	Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria. Scoring categories for marginal adaptation: Excellent/very good: No clinically detectable gap.; Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.; Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area.; Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base.; Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.	24 months post-restoration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of Restorative Material	The percentage of restorations with partial or complete loss of the restoration material.	6 months post-restoration
Marginal Adaptation	Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation: Excellent/very good: No clinically detectable gap.; Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.; Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area.; Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base.; Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.	6 months post restoration
Fracture of Restorative Material	Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows: Excellent/very good: No fractures/cracks; Good: Small hairline cracks; Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact; Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts	6 months post-restoration
Secondary Caries	Secondary caries in study teeth scored on scale 1-5.; Excellent/Very Good: No secondary or primary caries; Good: Small and localized areas of demineralization; Sufficient/Satisfactory: Larger areas of demineralization; Unsatisfactory: Caries with cavitation and suspected undermining caries; Poor: Deep caries or exposed dentin not accessible for repair of restoration.	6 months post-restoration
Retention of Restorative Material	The percentage of restorations with partial or complete loss of the restoration material.	12 months post-restoration
Marginal Adaptation	Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for marginal adaptation: Excellent/very good: No clinically detectable gap.; Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.; Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area.; Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base.; Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.	12 months post-restoration
Fracture of Restorative Material	Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows: Excellent/very good: No fractures/cracks; Good: Small hairline cracks; Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact; Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts	12 months post-restoration
Secondary Caries	Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows.; Excellent/Very Good: No secondary or primary caries; Good: Small and localized areas of demineralization; Sufficient/Satisfactory: Larger areas of demineralization; Unsatisfactory: Caries with cavitation and suspected undermining caries; Poor: Deep caries or exposed dentin not accessible for repair of restoration.	12 months post-restoration
Fracture of Restorative Material	Fractures on study teeth graded on a 1-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for the fracture of restorative material are defined as follows: Excellent/very good: No fractures/cracks; Good: Small hairline cracks; Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact; Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts	24 months post-restoration
Secondary Caries	Secondary caries in study teeth graded on a 1-5 grading scale with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. Scoring categories for secondary caries are defined as follows.; Excellent/Very Good: No secondary or primary caries; Good: Small and localized areas of demineralization; Sufficient/Satisfactory: Larger areas of demineralization; Unsatisfactory: Caries with cavitation and suspected undermining caries; Poor: Deep caries or exposed dentin not accessible for repair of restoration.	24 months post-restoration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface staining	Surface staining of study teeth scored on a scale of 1-5	baseline, 6 months, 12 months, 24 months
Marginal staining	Marginal staining of study teeth scored on a scale of 1-5	baseline, 6 months, 12 months, 24 months
Color match	Color match and translucency of study teeth on a scale of 1-5	baseline, 6 months, 12 months, 24 months
Polish retention	Polish retention (surface gloss / luster and roughness) scored on a scale of 1-7	baseline, 6 months, 12 months, 24 months
Post-operative hypersensitivity and tooth vitality	Post-operative hypersensitivity and tooth vitality upon exposure of the study teeth to a cold cotton pellet scored on a scale of 1-5	6 months, 12 months, 24 months
Time to restoration failure	Restoration retention survival time defined as the time between the restoration date and the first report of the presence of restoration failure	24 months
Patient satisfaction	Survey of patient satisfaction with aesthetics and function of tooth restorations	baseline, 6 months, 12 months, 24 months
Incidence of adverse events	Adverse device effects collected from time of restoration through 24-month follow-up visit	24 months
Baseline post-operative hypersensitivity (subject self-assessment)	Post-operative hypersensitivity assessed at baseline by the subject on a scale of 1-3	7 days

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Investigators: Principal Investigator: Alika Yu, DDS, Louisiana State University HSC Health, School of Dentistry

Publications and helpful links

General Publications

• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
• Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29.
• Burgess JO, Sadid-Zadeh R, Cakir D, Ramp LC. Clinical evaluation of self-etch and total-etch adhesive systems in noncarious cervical lesions: a two-year report. Oper Dent. 2013 Sep-Oct;38(5):477-87. doi: 10.2341/12-355-CR. Epub 2013 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Actual): April 7, 2025
• Study Completion (Actual): September 11, 2025

Study Registration Dates

• First Submitted: April 30, 2022
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: composite resins; clinical study; dental materials; dental adhesives; Scotchbond Universal; noncarious lesions; abfraction lesions; bonding, dental; Scotchbond Universal plus; Filtek
• Other Study ID Numbers: EM-11-050068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No