抜歯後の歯槽骨欠損に対する牛焼成骨移植材の修復効果の検討

[Evaluation of the effect of cattle calcined bone grafting material to repair alveolar bone defect after tooth extraction].

抄録

目的:

抜歯後の歯槽骨欠損に対する牛焼成骨移植材の充填効果と安全性を確認する。

PURPOSE: To verify the efficacy and safety of calcined cattle bone grafting material in filling alveolar bone defect after tooth extraction.

方法:

無作為化、拘束、並行、陽性対照多施設臨床試験を実施した。280名の被験者を無作為に実験群（牛焼成骨群）と対照群（Bio-Oss群）に均等に割り付けた。主な有効性の指標は、材料埋入24週後の画像変化であった。副次的な有効性の指標は、創傷治癒、拒絶反応、骨代謝、充填後の症状、骨感染の徴候であった。材料の安全性は、有害事象および重篤な有害事象の発生率で評価した。統計解析にはSAS8.2ソフトウェアを使用した。

METHODS: A randomized, bind, parallel, positive-control multicenter clinical trial was conducted. A total of 280 subjects were randomly assigned to either the experimental group (calcined cattle bone group) or control group (Bio-Oss group) equally. The main efficacy indicator was the imaging changes 24 weeks after material implantation. Secondary efficacy indicators were wound healing, rejection, bone metabolism, post-filling symptoms and signs of bone infection. The safety of material was assessed by the incidence of adverse events and serious adverse events. SAS 8.2 software package was used for statistical analysis.

結果:

合計280症例が対象となり、そのうち267症例が研究を完了し、13症例が脱落した。FAS（PPS）の有効率は実験群で90.58％（97.46％）、対照群で87.05％（95.04％）であった。実験群と対照群の有効率の差（95％CI）はFASで3.53％（-3.88％、10.94％）、PPSで2.42％（-2.38％、7.22％）であり、両群間に有意差はなかった。両群の切開治癒は良好で、拒絶反応、骨感染徴候、充填後症状、骨代謝変化の発生率は非常に低かった。有害事象の発生率は両群で同程度であり、試験材料に関連した重篤な有害事象は発生しなかった。

RESULTS: A total of 280 cases were included, of them 267 cases completed the study while 13 cases fell off. The effective rate of FAS(PPS) was 90.58%(97.46%) in the experimental group and 87.05% (95.04%) in the control group. The difference of effective rate between the experimental group and control group (95%CI) was 3.53% (-3.88%, 10.94%) of FAS, 2.42% (-2.38%, 7.22%) of PPS, and there was no significant difference between the two groups. The incision healing of the two groups was good, and the incidence of rejection, bone infection signs, post-filling symptoms and bone metabolic changes was very low. The incidence of adverse events was similar in the two groups, and no serious adverse events related to the study materials occurred.

結論:

抜歯後の歯槽骨欠損に対する焼成牛骨移植材の充填効果は、Bio-Ossと比較して劣るものではなく、歯槽骨欠損修復に対して安全かつ有効である。

CONCLUSIONS: The efficacy of calcined cattle bone grafting material in filling alveolar bone defect after tooth extraction is not inferior to that of Bio-Oss, and it is safe and effective for alveolar bone defect repair.