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36 Months Clinical Evaluation of a Self-Etch Bonding Agent
H.S. MALMSTRÖM1, R. CACCIATO2, Y.-F. REN2, M. YUNKER2, and T. DEROSA1, 1University of Rochester School of Medicine and Dentistry, NY, USA, 2University of Rochester Eastman Dental Center, NY, USA | New generation of adhesive systems use low PH resin primers to simultaneously demineralize and penetrate the tooth surfaces, thus reduce time of application. Objective: The purpose of this study is to evaluate the clinical performance of a simplified self etch adhesive system in posterior composite restorations over 36 months. Methods: A total of 40 subjects in need of 60 Class I and/or II resin based composite restorations were enrolled into the study. The restorations were placed by four calibrated and experienced clinicians. After tooth preparation a rubber dam was placed and when needed a metal matrix band used. The adhesive (Xeno IV self-etch adhesive: Dentsply Caulk) was placed with a scrubbing motion for two 20 second applications. Esthet-X (Dentsply-Caulk) hybrid resin based composite material was used to restore the teeth. Patients were recalled at 3, 6, 18 and 36 months at which time restoration was evaluated by two calibrated examiners for the following criteria: retention, anatomic form, color match, marginal adaptation, marginal discoloration and recurrent caries according to criteria per modified Cvar and Ryge and gingival index per Silness and Loe. If there was a disagreement the examiners established a consensus by reviewing and discussing their findings. Results: 26 subjects with 40 restorations returned for the 36 months follow-up evaluation. In regard to sensitivity, color match, retention and secondary caries all 40 restorations were rated Alpha. Anatomic form was rated Alpha in 39 restorations and Charlie in one. Marginal adaptation was rated Alpha in 33, Bravo in 6 and Charlie in one restoration. Marginal discoloration was rated Alpha in 29 and Bravo in 11 restorations. Conclusion: The result from this study indicate that Xeno IV self etching adhesive performed well over 36 months when used for Class I and II posterior restorations. |
Seq #158 - Clinical Trials Posters 10:45 AM-12:00 PM, Saturday, April 5, 2008 Hilton Anatole Hotel Trinity I - Exhibit Hall |
Back to the Dental Materials 4: Clinical Trials, Biocompatibility and Biologic Effects Program
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