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

NCT05361746 | Completed Results FDA Device

• 1 other identifier: EM-11-050068
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class V Non-carious Cervical Dental Lesions

Keywords

composite resins; dental adhesives; noncarious lesions; abfraction lesions; bonding, dental; clinical study; Scotchbond Universal plus; Scotchbond Universal; Filtek; dental materials

Outcome Measures

Primary Outcomes (2)

• 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: 1. Excellent/very good: No clinically detectable gap. 2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing. 3. Sufficient/Satisfactory: Leakage/discoloration is present but limited to the marginal area. 4. Unsatisfactory: Localized gap larger than 250 µm, may result in exposure of dentine or base. 5. Poor: Generalized gap larger than 250 µm or the restoration is loose but in situ, re-placement necessary.

  24 months post-restoration

Secondary Outcomes (10)

• Retention of Restorative Material

  6 months post-restoration

• Marginal Adaptation

  6 months post restoration

• Fracture of Restorative Material

  6 months post-restoration

• Secondary Caries

  6 months post-restoration

• Retention of Restorative Material

  12 months post-restoration

Study Arms (2)

SBU+ Treatment Group

EXPERIMENTAL

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

SBU Control Group

ACTIVE COMPARATOR

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

Interventions

Scotchbond Universal Adhesive DEVICE

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.

SBU Control Group

Scotchbond Universal Plus Adhesive DEVICE

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.

SBU+ Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead

Study Sites (1)

Louisiana State University HSC-Health, School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

Related Publications (3)

• 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.

  PMID: 20628774 BACKGROUND

• 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.

  PMID: 23327229 BACKGROUND

• 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.

  PMID: 26231300 BACKGROUND

Limitations and Caveats

There was a larger than expected amount of attrition during this study, resulting in fewer teeth assessed at the primary 2-year data than anticipated. With higher attrition, the precision of the estimates of the primary results is less than anticipated with slightly wider 95% confidence intervals. Additionally, there is a chance of attrition bias, where the characteristics of the participants who leave the study differ from those who remain.

Results Point of Contact

• Title: Paula Myhre
• Organization: Solventum US LLC

pemyhre1@solventum.com

6513948069

Study Officials

• Alika Yu, DDS

  Louisiana State University HSC Health, School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessments were performed by two dental examiners that were independent of the dentist that placed the restorations and were blinded to the treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each subject had 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 were 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).

Study Record Dates

• First Submitted: April 30, 2022
• First Posted: May 5, 2022
• Study Start: August 18, 2022
• Primary Completion: April 7, 2025
• Study Completion: September 11, 2025
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)