CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Adhesive: OptiBond XTR; Composite: Herculite Ultra +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01464996
NCT01464996N/ACompleted

Clinical Evaluation Of A New Two-Component Self-Etch Universal Adhesive (OptiBond XTR)

University of North Carolina, Chapel Hill·interventional·Posted Nov 4, 2011·Updated Jul 27, 2015

In Brief

A clinical study evaluating Adhesive: OptiBond XTR; Composite: Herculite Ultra and Adhesive: OptiBond FL; Composite: Herculite Ultra for Composite Restorations and Tooth Lesions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsKerr Corporation

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.7 years ago

Interventions

Adhesive: OptiBond XTR; Composite: Herculite Ultraprocedure

The intervention in Arm 1 (Adhesive: OptiBond XTR; Composite: Herculite Ultra) is a 2-step, self-etching adhesive.

Adhesive: OptiBond FL; Composite: Herculite Ultraprocedure

Arm 2 (Adhesive: OptiBond FL; Composite: Herculite Ultra) is a 3-step, etch-and-rinse adhesive.