CompletedNot Applicable

Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

United States33 participantsStarted 2014-06

Plain-language summary

The purpose of this prospective clinical trial will be to evaluate the efficacy of an FDA approved and marketed universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches. The hypothesis is that using a selective enamel etch with this universal adhesive will enhance the restoration margin performance.

Who can participate

Age range20 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing to provide written consent and authorization for participation.
✓. Be between 20 and 75 years of age at the time of recruitment
✓. Have at least two non-carious cervical lesions present in canine or premolar teeth;
✓. Anticipates availability for recalls (roughly 6 month, 12 month, and 24 month) through the two-year study period
✓. The lesions selected will be at least 1 mm in depth (measured with a perio probe) and contain both enamel and dentin margins.

Exclusion criteria

✕.2. Exclusion criteria
✕. Severe medical complications (organ transplants, cancer, immunocompromised, long term antibiotic or steroid therapy);
✕. Active caries on study teeth;
✕. Bleeding on probing of study teeth;
✕. Generalized severe periodontitis;
✕. Patient reported symptoms (burning mouth, loss or diminished taste, saliva amount too little, needs liquids to eat dry foods) or clinical signs (erythematous tongue, chelitis, lack of pooled saliva) associated with dry mouth;
✕. Patients determined to be at a high risk of caries as determined by a Caries Risk Assessment

What they're measuring

Retention of Restorations

Timeframe: 6, 12, 24 months

Trial details

NCT IDNCT02172664

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05

Results submitted2019-05-23

View on ClinicalTrials.gov More Cervical Lesions trials