N/A
N=24
Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive
Composite Restorations · Tooth Lesions
Bottom Line
View on ClinicalTrials.gov: NCT01464996 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Retention — 100; 100; 100; 97 percentage of restorations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Adhesive: OptiBond XTR; Composite: Herculite Ultra (Procedure); Adhesive: OptiBond FL; Composite: Herculite Ultra (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
100; 100; 100; 97 | — |
| SECONDARY Color Match |
89; 76 | — |
| SECONDARY Cavosurface Margin Discoloration |
89; 92 | — |
| SECONDARY Secondary Caries |
100; 100 | — |
| SECONDARY Anatomic Form |
97; 92 | — |
| SECONDARY Marginal Adaptation and/or Integrity |
97; 89 | — |
| SECONDARY Post Operative Sensitivity |
100; 100 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01464996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.