Discipline of Periodontics, School of Dentistry, University of São Paulo, São Paulo, Brazil.
Clinic for Fixed and Removable Prosthodontics and Dental Material Science, University of Zurich, Zurich, Switzerland.
J Clin Periodontol. 2019 Mar;46(3):373-381. doi: 10.1111/jcpe.13079. Epub 2019 Mar 3.
To test the non-inferiority of demineralized bovine bone mineral (DBBM) compared to DBBM with 10% collagen (DBBM-C) for maintenance of bone volume after tooth extraction in the anterior maxilla.
Sixty-six patients were randomly treated with DBBM or DBBM-C, both of which were covered with a collagen matrix for ridge preservation in the anterior maxilla. Cone-beam computed tomographic analysis was performed immediately and 4 months after treatment. The primary outcome, for which non-inferiority of DBBM was tested, was change in the horizontal ridge width 1 mm below the buccal alveolar crest (HW-1) 4 months after extraction.
Four months after extraction, HW-1 measured -1.60 mm ± 0.82 mm for DBBM-C, while the DBBM group showed a mean loss of -1.37 mm ± 0.84 mm (p = 0.28, 0.23 [95% CI: -0.19; 0.64]). The horizontal ridge width at 3 mm (HW-3) showed -0.98 mm (±0.67 mm) for DBBM-C and -0.84 mm (±0.62 mm) for DBBM (p = 0.40, 0.12 [95% CI: -0.19; 0.45]), and the horizontal ridge width at 5 mm (HW-5) showed -0.67 mm (±0.47 mm) for DBBM-C and -0.56 mm (±0.48 mm) for DBBM (p = 0.36, 0.11 [95% CI: -0.13; 0.34]).
The present clinical trial demonstrated non-inferiority of DBBM compared to DBBM-C for maintenance of alveolar bone volume 4 months after tooth extraction in the anterior maxilla.
在前上颌牙槽嵴颊侧 1mm 处,比较脱矿牛骨矿物质(DBBM)与含 10%胶原的 DBBM(DBBM-C)在维持拔牙后骨量方面的非劣效性。
66 例患者随机接受 DBBM 或 DBBM-C 治疗,两者均用胶原基质覆盖在前上颌牙槽嵴保存。治疗后即刻和 4 个月进行锥形束 CT 分析。主要结局是 4 个月时牙槽嵴颊侧 1mm 处水平骨宽度(HW-1)的变化,检验 DBBM 的非劣效性。
拔牙后 4 个月,DBBM-C 组 HW-1 平均减少 1.60mm±0.82mm,而 DBBM 组平均减少 1.37mm±0.84mm(p=0.28,0.23[95%CI:-0.19;0.64])。3mm 处水平骨宽度(HW-3)DBBM-C 组为-0.98mm±0.67mm,DBBM 组为-0.84mm±0.62mm(p=0.40,0.12[95%CI:-0.19;0.45]),5mm 处水平骨宽度(HW-5)DBBM-C 组为-0.67mm±0.47mm,DBBM 组为-0.56mm±0.48mm(p=0.36,0.11[95%CI:-0.13;0.34])。
本临床试验表明,在前上颌牙槽嵴颊侧 1mm 处,DBBM 维持拔牙后牙槽骨体积的非劣效性与 DBBM-C 相当。