Clinical Evaluation of a Universal Adhesive in Noncarious Cervical Lesions
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cervical Lesions
- Sponsor
- Indiana University
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Retention of Restorations
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed Description
The purpose of this prospective clinical trial will be to evaluate the efficacy of a newly formulated universal dental adhesive formulation in adult noncarious cervical lesions using self-etch and selective etch approaches. Thirty-three patients with at least two non-carious cervical lesions will receive one restoration utilizing the self-etch universal adhesive with no separate enamel etching and another restoration utilizing the universal adhesive and a a selective etch protocol in which in which enamel is etched with 37% phosphoric acid. After a screening/baseline visit at which the restorative procedures listed above will conducted, the patient will be seen at recall visits after approximately 6, 12 and 24 months to observe sensitivity, retention, marginal discoloration and marginal adaptation.
Investigators
Jeffrey A. Platt
Associate Professor of Dental Materials
Indiana University
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Retention of Restorations
Time Frame: 6, 12, 24 months
The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration.
Secondary Outcomes
- Number of Restoration Margins Marked as Stained or Discolored(6, 12, 24 months)