Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive

Completed · Not applicable

Conditions studied: Composite Restorations, Tooth Lesions

In brief

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.

Key facts

Study ID

NCT01464996

Run by

University of North Carolina, Chapel Hill

People needed

24

Starts

2011-12-01

Expected to finish

2014-03-01

Last updated by the study team

2015-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of North Carolina at Chapel Hill School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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