N/A N=64 Randomized Single-blind Treatment

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

Class V Non-carious Cervical Dental Lesions

Bottom Line

View on ClinicalTrials.gov: NCT05361746 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Apr 2026

Primary outcome: Primary: Retention of Restorative Material — 83; 85; 17; 15 percentage of restorations

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Scotchbond Universal Plus Adhesive (Device); Scotchbond Universal Adhesive (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Solventum US LLC
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Retention of Restorative Material	87; 89; 13; 11	—
PRIMARY Marginal Adaptation	82; 76; 9; 15; 9; 9	—
SECONDARY Retention of Restorative Material	87; 89; 13; 11	—
SECONDARY Marginal Adaptation	82; 76; 9; 15; 9; 9	—
SECONDARY Fracture of Restorative Material	91; 97; 6; 0; 3; 0	—
SECONDARY Secondary Caries	97; 97; 3; 3; 0; 0	—
SECONDARY Retention of Restorative Material	87; 89; 13; 11	—
SECONDARY Marginal Adaptation	82; 76; 9; 15; 9; 9	—
SECONDARY Fracture of Restorative Material	91; 97; 6; 0; 3; 0	—
SECONDARY Secondary Caries	97; 97; 3; 3; 0; 0	—
SECONDARY Fracture of Restorative Material	91; 97; 6; 0; 3; 0	—
SECONDARY Secondary Caries	97; 97; 3; 3; 0; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05361746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.