Shanghai Journal of Stomatology

Shanghai Journal of Stomatology ›› 2023, Vol. 32 ›› Issue (2): 198-202.doi: 10.19439/j.sjos.2023.02.016

• Original Articles • Previous Articles     Next Articles

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

JU Jia1, YANG Chi2, WU He-ming3, ZHAO Ji-hong4, CHENG Li-fei1, ZHANG Huan1, FENG Bin1, HU Kai-jin5   

  1. 1. State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Engineering Research Center for Dental Materials and Advanced Manufacture, Medical Institution Conducting Clinical Trials for Human Used Drug, Department of Pharmacy, Third Affiliated Hospital of Air Force Medical University. Xi'an 710032, Shaanxi Province;
    2. Department of Oral Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. Shanghai 200011;
    3. Department of Oral and Maxillofacial Surgery, Stomatological Hospital of Nanjing Medical University. Nanjing 210000, Jiangsu Province;
    4. Department of Oral and Maxillofacial Surgery, Stomatological Hospital of Wuhan University. Wuhan 430079, Hubei Province;
    5. State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Oral Surgery, Third Affiliated Hospital of Air Force Medical University, Xi'an 710032, Shaanxi Province, China
  • Received:2022-01-03 Revised:2022-03-16 Online:2023-04-25 Published:2023-06-13

PDF (PC)

104

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

Key words: Calcined cattle bone grafting material, Bio-Oss, Tooth extraction, Alveolar bone defect

CLC Number: