Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions

Completed · Not applicable

Conditions studied: Cervical Lesions

In brief

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.

Key facts

Study ID

NCT02172664

Run by

Indiana University

People needed

33

Starts

2014-06-01

Expected to finish

2018-05-01

Last updated by the study team

2019-05-28

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 1.1. 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.

You may not qualify if…

• 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

Where it is running

• Indiana University School of Dentistry — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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