Department of Prosthodontics, Peking University School of Stomatology, Beijing, China.
Department of the Fourth Clinical Division, Peking University School of Stomatology, Beijing, China.
BMJ Open. 2021 Dec 7;11(12):e053286. doi: 10.1136/bmjopen-2021-053286.
Implant-supported prostheses are often successfully used in edentulous patients. However, the incidences of peri-implant mucositis and peri-implantitis increase over time. The accumulation of pathogenic bacteria adjacent to prostheses can induce peri-implant disease. Plaque removal is recommended to prevent and manage peri-implant diseases. The purpose of this study is to compare the plaque removal efficacy of ultrasonic debridement with/without erythritol air-polishing powder around implants and bridges in patients with full-arch fixed implant-supported prostheses as well as the effects of these two methods on the rates of peri-implant mucositis and peri-implantitis, and the submucosal microbiota composition over 5 years in patients undergoing supportive periodontal therapy.
We plan to enrol 10 edentulous (maxilla and/or mandible) patients seeking full-arch fixed implant-supported prostheses. The study will use a split-mouth model in which contralateral quadrants are randomly assigned to two groups. Group 1: one contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement combined with erythritol air-polishing powder. Group 2: a separate contralateral quadrant of full-arch fixed implant-supported prostheses will undergo ultrasonic debridement. The 5-year trial will involve a total of 10 re-examinations per participant. The mucosal conditions around the implants will be recorded at 6-month intervals after restoration. Peri-implant submucosal plaque will be collected at each re-examination, and the bacterial flora will be analysed by 16s ribosomal RNA gene sequencing. X-ray examinations will be conducted at 12-month intervals to evaluate the marginal bone level around implants.
This prospective single-centre, randomised controlled trial (PKUSSIRB-202054045) has been approved by the Ethics Committee of Stomatology School and Hospital of Peking University. Data will be registered with the International Clinical Trials Registry Platform. Additionally, we will disseminate the results via publication in scientific journals.
ChiCTR-2000032431.
种植体支持的修复体在无牙患者中常被成功应用。然而，种植体周围黏膜炎和种植体周围炎的发生率会随时间增加。毗邻种植体的致病性细菌的积累会导致种植体周围疾病。建议通过清除菌斑来预防和管理种植体周围疾病。本研究旨在比较超声洁治术联合/不联合赤藓糖醇喷砂粉去除种植体和种植桥周围菌斑的效果，以及这两种方法对 5 年内接受支持性牙周治疗的全颌固定式种植义齿患者的种植体周围黏膜炎和种植体周围炎发生率以及黏膜下微生物群落组成的影响。
我们计划招募 10 名寻求全颌固定式种植义齿的无牙（上颌和/或下颌）患者。该研究将采用分口模型，将对侧象限随机分为两组。第 1 组：全颌固定式种植义齿的一侧对侧象限同时接受超声洁治术联合赤藓糖醇喷砂粉治疗。第 2 组：全颌固定式种植义齿的另一侧对侧象限单独接受超声洁治术。每位参与者的 5 年试验将共进行 10 次复查。修复后每 6 个月记录一次种植体周围黏膜状况。每次复查时都将采集种植体周围黏膜下菌斑，并通过 16s 核糖体 RNA 基因测序分析细菌菌群。每隔 12 个月进行 X 射线检查，以评估种植体周围的边缘骨水平。
这项前瞻性单中心、随机对照试验（PKUSSIRB-202054045）已获得北京大学口腔医学院和医院伦理委员会的批准。数据将在国际临床试验注册平台上注册。此外，我们将通过在科学期刊上发表来传播研究结果。
ChiCTR-2000032431。
