Status:
COMPLETED
Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Kerr Corporation
Conditions:
Composite Restorations
Tooth Lesions
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This randomized clinical trial evaluates the clinical performance of a new two-component self-etch universal adhesive, OptiBond XTR, when applied in non-carious Class V cervical lesions without macrom...
Detailed Description
CLINICAL RESEARCH PLAN Introduction This randomized clinical trial involved the restoration and evaluation of 83 (target enrollment was 80) non-carious cervical lesions (NCCLs) using either the new ...
Eligibility Criteria
Inclusion
- Subjects needing restoration of NCCLs (these include some cases where the patient has hypersensitivity and a restoration is indicated)
- Subjects with age range 18-80 years old
- Teeth with normal occlusion relationships
Exclusion
- Subjects with fewer than 20 teeth
- Subjects with poor oral hygiene and/or uncontrolled periodontal disease
- Teeth with NCCLs with mechanical undercuts
- Subjects with known allergies to HEMA or resin-based materials. The materials to be used are HEMA and/or resin-based materials.
- Subjects with medical conditions that contraindicate dental treatment.
- Subjects with xerostomia. Xerostomia is a condition where there is a decrease salivary flow (dry mouth). Decrease salivary flow is a known factor that affects the long-term prognosis of dental restorations, and would be a confounder.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01464996
Start Date
December 1 2011
End Date
March 1 2014
Last Update
July 27 2015
Active Locations (1)
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1
University of North Carolina at Chapel Hill School of Dentistry
Chapel Hill, North Carolina, United States, 27599