CompletedNot Applicable

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

United States38 participantsStarted 2022-08-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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:
✓. 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

✕. Subject has any of the following:
✕. 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

What they're measuring

Retention of Restorative Material

Timeframe: 24 months post-restoration

Marginal Adaptation

Timeframe: 24 months post-restoration

Trial details

NCT IDNCT05361746

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-07

Results submitted2026-03-03

View on ClinicalTrials.gov More Class V Non-carious Cervical Dental Lesions trials