N/A
Completed N=64
Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs
Class V Non-carious Cervical Dental Lesions
Source: ClinicalTrials.gov NCT05361746 ↗
Enrolled (actual)
64
Serious AEs
6.3%
Results posted
Apr 2026
Primary outcomePrimary: Retention of Restorative Material — 83; 85; 17; 15 percentage of restorations
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.
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 | — |
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
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. Informational only — not medical advice.