Journal of Oral Science Research

Journal of Oral Science Research ›› 2022, Vol. 38 ›› Issue (9): 848-853.DOI: 10.13701/j.cnki.kqyxyj.2022.09.011

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Clinical Trial of Small Intestinal Submucosa Absorbable Bio-films in Reconstruction of Alveolar Bone and/or Soft Tissues.

JU Jia1, LIU Yuhua2, ZHAO Jizhi3, ZHAO Jihong4, LI Hongwei5, WANG Baoyan6, WANG Hu7, ZHANG Huan1, FENG Bin1*, HU Kaijin2*   

  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, School of Stomatology, The Fourth Military Medical University, Xi’an 710032, China;
    2. Department of Prosthodontics, Peking University Stomatological Hospital, Beijing 100050, China;
    3. Department of Oral and Maxillofacial Surgery, Peking Union Hospital, Chinese Academy of Medical Sciences, Beijing 100005, China;
    4. Department of Oral and Maxillofacial Surgery, Hospital of Stomatology Wuhan University, Wuhan 430079, China;
    5. Department of Oral and Maxillofacial Surgery, Stomatological Hospital of Nanjing Medical University, Nanjing 210000, China;
    6. Department of Periodontal Mucosa, Hospital of Stomatology Xi'an Jiaotong University, Xi'an 710032, China;
    7. Department of Oral Radiology, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China;
    8. State Key Laboratory of Military Stomatology & National Clinical Research Center for Oral Diseases & Shaanxi Clinical Research Center for Oral Diseases, Department of Oral Surgery, School of Stomatology, The Fourth Military Medical University, Xi’an 710032, China.
  • Received:2021-11-04 Published:2022-09-26

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Abstract: Objective: To evaluate the efficacy and safety of small intestinal submucosa (SIS) absorbable biofilms in reconstructing alveolar bone and/or soft tissue. Methods: Randomized, single-bind, parallel-control, multicenter, non-inferiority trial design was used. The main measures were the changes of the maximum length, height, and width in alveolar bone 0 and 180 days after operation. Secondary measures included changes in alveolar bone hyperplasia and resorption, changes in alveolar bone matrix marginal line, damage of biofilm, surgical incision healing, rejection reaction, and post-filling symptoms. The safety of SIS absorbable biofilms was evaluated by frequency and severity of adverse events. Results: A total of 280 cases were included in this study. Two hundred and seventy-two cases completed the trial and the abscission rate was 2.86% (8 cases). The imaging effective rate of FAS (PPS) after 180 days was 83.57% (91.34%) in the experimental group and 81.43% (92.62%) in the control group, and 95%CI was 2.14% (-6.75%, 11.04%) in FAS and -1.28% (-8.03%, 5.46%) in PPS (P>0.05). The changes of alveolar bone growth and resorption, alveolar bone matrix marginal line, experimental membrane damage 12 days after surgery, clinical incision healing, rejection reaction, and filling status of each visiting point had no significant differences between two groups (P>0.05). The incidence of adverse events and serious adverse events during the treatment had no significant difference (P>0.05). Conclusion: SIS absorbable biofilms were non-inferior to Bio-Gide absorbable biofilms in reconstructing alveolar bone and/or soft tissue.

Key words: SIS absorbable biofilms, alveolar bone, soft tissue, reconstruction, clinical research