Department of Periodontology, Peking University School and Hospital of Stomatology and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology, Beijing, China.
Department of Periodontology, Peking University School and Hospital of Stomatology and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology, Beijing, China
BMJ Open. 2020 Dec 10;10(12):e040046. doi: 10.1136/bmjopen-2020-040046.
Periodontal regeneration surgery has been widely used to deal with intrabony defects. Modified minimally invasive surgical technique (M-MIST) is designed to deal with isolated interdental intrabony defects, and has achieved satisfactory periodontal regenerative effect. Bio-Oss Collagen, as a bioactive material, has been applied for periodontal regeneration. It is similar to human cancellous bone, with the ability to promote bone formation; furthermore, it has exceptional plasticity and spatial stability. The combination of different materials and techniques has become a research hotspot in recent years. By combining the superiority of regeneration technology and materials, better regenerative effect can be achieved. This study will search for differences between M-MIST combined with Bio-Oss Collagen, and M-MIST alone in regeneration therapy for intrabony defects.
The present research is designed as a two-group parallel randomised controlled trial. The total number of patients is 40. The patients will be randomly assigned to two groups, with 20 participants in each group, for further periodontal regenerative surgery. Test group: M-MIST plus Bio-Oss Collagen.
M-MIST. After 12 months, the measurement indices will be recorded; these will include clinical attachment gain and radiographical intrabony defect depth change as the primary results, and secondary outcomes of full-mouth plaque scores, probing depth, full-mouth bleeding scores, gingival recession, mobility, gingival papilla height and Visual Analogue Scale. The paired samples t-test will be applied to detect any difference between baseline and 1-year registrations. A general linear model will be performed to study the relationship between the secondary and the primary outcome.
The present research has received approval from the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-202053002). Data of the present research will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results through scientific dental journals.
ChiCTR-2000030851.
Protocol Version 4, 14 July 2020.
牙周再生手术已广泛应用于处理骨内缺损。改良微创外科技术（M-MIST）旨在处理孤立的牙间骨内缺损，并已取得令人满意的牙周再生效果。Bio-Oss 胶原作为一种生物活性材料，已被应用于牙周再生。它与人的松质骨相似，具有促进骨形成的能力；此外，它具有出色的可塑性和空间稳定性。近年来，不同材料和技术的结合已成为研究热点。通过结合再生技术和材料的优势，可以达到更好的再生效果。本研究将探讨 M-MIST 联合 Bio-Oss 胶原与单独 M-MIST 在骨内缺损再生治疗中的差异。
本研究设计为两组平行随机对照试验。总共有 40 名患者。将患者随机分为两组，每组 20 名，进一步进行牙周再生手术。实验组：M-MIST 加 Bio-Oss 胶原。对照组：M-MIST。12 个月后，记录测量指标；这些将包括临床附着体获得和影像学骨内缺损深度变化作为主要结果，以及全口菌斑评分、探诊深度、全口出血评分、牙龈退缩、松动度、牙龈乳头高度和视觉模拟评分的次要结果。采用配对样本 t 检验检测基线和 1 年登记之间的差异。采用一般线性模型研究次要和主要结果之间的关系。
本研究已获得北京大学口腔医学院和医院伦理委员会的批准（PKUSSIRB-202053002）。本研究的数据将在国际临床试验注册平台上注册。此外，我们将通过科学的牙科期刊传播研究结果。
ChiCTR-2000030851。
方案版本 4，2020 年 7 月 14 日。
