Deuk-Won Jo1, Young-Dan Cho2, Yang-Jo Seol2, Yong-Moo Lee2, Hyo-Jung Lee3, Young-Kyun Kim4,5. 1. Department of Prosthodontics, Section of Dentistry, Seoul National University Bundang Hospital, Seongnam, Korea. 2. Department of Periodontology & Dental Research Institute, School of Dentistry, Seoul National University, Seoul, Korea. 3. Department of Periodontology, Section of Dentistry, Seoul National University Bundang Hospital, Seongnam, Korea. 4. Department of Oral and Maxillofacial Surgery, Section of Dentistry, Seoul National University Bundang Hospital, Seongnam, Korea. 5. Department of Dentistry & Dental Research Institute, School of Dentistry, Seoul National University, Seoul, Korea.
Abstract
OBJECTIVES: This 12-week clinical trial evaluated efficacy and adverse events for two recombinant human bone morphogenetic protein-2 (rhBMP-2) delivery systems in alveolar ridge preservation. MATERIALS AND METHODS:Sixty-four patients had a single tooth that required replacement with an implant, surrounded by > 50% alveolar bone height. Two cohorts (n = 32 patients each) were randomized to receive a rhBMP-2-soaked absorbable collagen sponge (test group), or β-tricalcium phosphate andhydroxyapatite particles (control group) immersed in rhBMP-2, at the implant site. Bone height and width changes at 25%, 50%, and 75% of extraction socket level (ESL) were compared. Adverse events were assessed in the same period. In addition to the randomized controlled clinical trial, histological analysis of 21 patients (test group [n = 12], control group [n = 9]) was conducted, 4 months after alveolar ridge preservation. A non-inferiority test was used to analyze changes in alveolar bone height between groups (p = 0.05). A Wilcoxon rank-sum test was used to analyze changes in alveolar bone width and histomorphometric results between groups (p = 0.05). RESULTS: All patients showed good healing without severe adverse events. The lower limit of the one-sided 97.5% confidence interval in the difference between the two groups was 0.0033 (non-inferiority margin: -0.185); thus, the test group showed non-inferiority to the control group. Wilcoxon rank-sum test analysis did not show statistically significant differences between groups with regard to changes in alveolar bone width and histomorphometric analysis. CONCLUSIONS: The delivery systems showed similar efficacy for alveolar ridge preservation without severe adverse events.
RCT Entities:
OBJECTIVES: This 12-week clinical trial evaluated efficacy and adverse events for two recombinant humanbone morphogenetic protein-2 (rhBMP-2) delivery systems in alveolar ridge preservation. MATERIALS AND METHODS: Sixty-four patients had a single tooth that required replacement with an implant, surrounded by > 50% alveolar bone height. Two cohorts (n = 32 patients each) were randomized to receive a rhBMP-2-soaked absorbable collagen sponge (test group), or β-tricalcium phosphate and hydroxyapatite particles (control group) immersed in rhBMP-2, at the implant site. Bone height and width changes at 25%, 50%, and 75% of extraction socket level (ESL) were compared. Adverse events were assessed in the same period. In addition to the randomized controlled clinical trial, histological analysis of 21 patients (test group [n = 12], control group [n = 9]) was conducted, 4 months after alveolar ridge preservation. A non-inferiority test was used to analyze changes in alveolar bone height between groups (p = 0.05). A Wilcoxon rank-sum test was used to analyze changes in alveolar bone width and histomorphometric results between groups (p = 0.05). RESULTS: All patients showed good healing without severe adverse events. The lower limit of the one-sided 97.5% confidence interval in the difference between the two groups was 0.0033 (non-inferiority margin: -0.185); thus, the test group showed non-inferiority to the control group. Wilcoxon rank-sum test analysis did not show statistically significant differences between groups with regard to changes in alveolar bone width and histomorphometric analysis. CONCLUSIONS: The delivery systems showed similar efficacy for alveolar ridge preservation without severe adverse events.
Authors: L Canullo; M Del Fabbro; S Khijmatgar; S Panda; A Ravidà; G Tommasato; A Sculean; P Pesce Journal: Clin Oral Investig Date: 2021-11-26 Impact factor: 3.606
Authors: Momen A Atieh; Nabeel Hm Alsabeeha; Alan Gt Payne; Sara Ali; Clovis M Jr Faggion; Marco Esposito Journal: Cochrane Database Syst Rev Date: 2021-04-26
Authors: Su A Park; Hyo-Jung Lee; Sung-Yeol Kim; Keun-Suh Kim; Deuk-Won Jo; Shin-Young Park Journal: J Biomed Mater Res A Date: 2020-08-22 Impact factor: 4.396