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

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.