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两种牙槽嵴保存骨替代材料的比较:一项非劣效性随机对照临床试验的锥形束 CT 结果。

Comparison between two bone substitutes for alveolar ridge preservation after tooth extraction: Cone-beam computed tomography results of a non-inferiority randomized controlled trial.

机构信息

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.

出版信息

J Clin Periodontol. 2019 Mar;46(3):373-381. doi: 10.1111/jcpe.13079. Epub 2019 Mar 3.

Abstract

AIM

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.

MATERIALS AND METHODS

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.

RESULTS

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]).

CONCLUSIONS

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.

摘要

目的

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。

材料与方法

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。

结果

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])。

结论

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。

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