Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive (OptiBond XTR)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Retention
Study Overview
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 macromechanical retention (retentive grooves or bevels). The control material is OptiBond FL, a "traditional" etch/prime/bond adhesive with documented clinical performance. Eighty non-carious Class V cervical lesions are divided into two groups to be treated with either OptiBond XTR or OptiBond FL. Both adhesives are applied strictly according to the manufacturer's directions. Herculite Ultra, a nano-hybrid resin-based composite, is used as the restorative material with both adhesives. The restorations will be evaluated at insertion (baseline), 6 months, and 18 months. An optional three-year recall evaluation is also proposed. The investigators hypothesize that both adhesives will have comparable performance.
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 two-component self-etch universal adhesive OptiBond XTR or a control dental adhesive, OptiBond FL, and a nano-hybrid composite restorative material, Herculite Ultra. OptiBond XTR is a two-component self-etch, filled, fluoride releasing, light-cured bonding agent designed for the universal bonding of direct and indirect restorations. The study design was based on the American Dental Association Acceptance Program Guidelines for Dentin and Enamel Adhesive Materials.
Participant Selection Criteria
Participants were selected on the basis of requiring restorations of non-carious cervical lesions. Participants with fewer than 20 teeth were not considered. The participant pool was randomized as much as possible to exclude bias due to age (18 to 80 years old), sex, race, national origin, or other factors such as unusual dietary, habitual, or oral hygiene factors which might affect the results. If the participant pool included these effects, they will be acknowledged in all project reports. Despite our efforts to have close to equal numbers of men and women in the study (ADA Guidelines, 2001), as noted in this report our pool was imbalanced towards women (we enrolled 20 females and 4 males). However, we do not believe this gender imbalance will affect or bias the results.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Retention
Time Frame: 6 and 18 months post-baseline
Overall retention of restorations
Secondary Outcomes
- Color Match(18 months post-baseline)
- Anatomic Form(18 months post-baseline)
- Marginal Adaptation and/or Integrity(18 months post-baseline)
- Cavosurface Margin Discoloration(18 months post-baseline)
- Secondary Caries(18 months post-baseline)
- Post Operative Sensitivity(18 months post-baseline)
Investigators
André V. Ritter, DDS, MS
Professor UNC School of Dentistry
University of North Carolina, Chapel Hill