带冠向推进瓣的脱细胞真皮基质移植物治疗薄龈型Miller 分类 I/II 型单个牙龈退缩的疗效：一项随机对照分口研究方案。
Effectiveness of acellular dermal matrix graft with a coronally advanced flap for the treatment of Miller Class I/II single gingival recession with thin gingival phenotype: study protocol for a split-mouth randomised controlled trial.
机构信息
First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & Research Center of Engineering and Technology for Computerized Dentistry Ministry of Health & NMPA Key Laboratory for Dental Materials, Beijing, Beijing, PR China.
First Clinical Division, Peking University School and Hospital of Stomatology & National Center of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices & Beijing Key Laboratory of Digital Stomatology & Research Center of Engineering and Technology for Computerized Dentistry Ministry of Health & NMPA Key Laboratory for Dental Materials, Beijing, Beijing, PR China
出版信息
BMJ Open. 2022 Jan 25;12(1):e047703. doi: 10.1136/bmjopen-2020-047703.
INTRODUCTION
Gingival recession is one of the most common mucogingival deformities requiring surgical correction. The American Academy of Periodontology Regeneration Workshop recommended connective tissue graft (CTG) combined with coronally advanced flap (CAF) for the treatment of Miller Class I and II single-tooth gingival recession. The disadvantages of harvesting autogenous tissue include postoperative bleeding, pain and discomfort at the donor site, restricted tissue supply, increased morbidity and prolonged operative times. Acellular dermal matrix (ADM) contains undamaged collagen and elastin matrices that can be used as a substitute for CTG during root coverage procedures. However, the use of ADM is still controversial. The objective of this split-mouth; randomised, controlled, clinical study is to evaluate the long-term effects of ADM graft (ADMG) combined with CAF on root coverage, aesthetics and patient satisfaction for the treatment of single gingival recession with thin gingival phenotype.
METHODS AND ANALYSIS
Forty participants with bilateral Miller Class I/II gingival recession will be randomised to receive an ADMG on one side and CTG on the contralateral side, combined with CAF. Gingival recession depth, gingival recession width and keratinised tissue width will be measured at baseline, 2 weeks and 1, 3, 6, 12 and 24 months. Mean root coverage, complete root coverage, root coverage aesthetic score, colour change (∆E) and patient satisfaction will be assessed during follow-up visits.
ETHICS AND DISSEMINATION
The present study has received approval from the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-202054029). Data of this study will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results through scientific journal.
TRIAL REGISTRATION NUMBER
ChiCTR2000033230.
简介
牙龈退缩是最常见的黏膜-牙周组织变形之一，需要手术矫正。美国牙周病学会再生研讨会建议使用结缔组织移植物（CTG）联合冠向推进瓣（CAF）治疗 Miller Ⅰ类和Ⅱ类单颗牙牙龈退缩。自体组织采集的缺点包括术后出血、供区疼痛不适、组织供应受限、发病率增加和手术时间延长。脱细胞真皮基质（ADM）含有未受损的胶原和弹性蛋白基质，可在根覆盖术中替代 CTG。然而，ADM 的使用仍存在争议。本研究采用随机对照临床试验，旨在评估 ADM 移植物（ADMG）联合 CAF 治疗薄龈型单颗牙龈退缩的长期效果，包括根覆盖、美学和患者满意度。
方法和分析
40 名双侧 Miller Ⅰ/Ⅱ类牙龈退缩患者将被随机分为两组，一组接受 ADMG，另一组接受 CTG，均联合 CAF。在基线、2 周和 1、3、6、12 和 24 个月时测量牙龈退缩深度、牙龈退缩宽度和角化组织宽度。在随访期间评估平均根覆盖、完全根覆盖、根覆盖美学评分、颜色变化（∆E）和患者满意度。
伦理和传播
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-202054029）。本研究的数据将在国际临床试验注册平台上注册。此外，我们将通过科学期刊传播研究结果。
临床试验注册号
ChiCTR2000033230。
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