Effectiveness of Non-Surgical Mechanical Therapy of Peri-Implantitis With or Without Prosthetic Crown Removal: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Peri-implant probing depth (PIPD)
研究概览
简要总结
The aim of this single-blind, randomized controlled clinical trial is to evaluate whether removal of the prosthetic crown influences the clinical effectiveness of non-surgical mechanical therapy in implants affected by peri-implantitis.
The study is designed to compare changes in several clinical and radiographic parameters between baseline and follow-up examinations at 3, 6, and 12 months. The primary outcome measure will be the mean peri-implant probing depth (PIPD). Secondary outcomes will include changes in gingival recession (REC), radiographic marginal bone level (MBL), modified bleeding index (mBI), and additional patient-related variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with at least one implant diagnosed with peri-implantitis (Berglundh et al., 2018);
- •Patients with a crown on the implant affected by peri-implantitis that is removable;
- •Patients who have not received non-surgical peri-implant therapy in the previous 6 months;
- •Patients who have not taken systemic antibiotic therapy in the previous 3 months.
排除标准
- •Full-Mouth Plaque Score (FMPS) > 30% at the time of non-surgical therapy;
- •Pregnant or breastfeeding women;
- •Relevant medical history, in the opinion of the examining clinician, that could affect the outcome of non-surgical peri-implant therapy;
- •Smoking patients consuming > 10 cigarettes/day.
研究组 & 干预措施
Non-surgical therapy with prosthetic crown removal
Implants allocated to this group will receive non-surgical peri-implant therapy after temporary removal of the prosthetic crown. The crown will be unscrewed before treatment to allow direct access and full visibility of the implant surface and peri-implant tissues. Mechanical debridement will then be performed under local anesthesia using sonic and ultrasonic devices with dedicated thin tips and Gracey curettes, according to the EFP S3-level clinical practice guidelines. After completion of debridement and biofilm removal, the prosthetic crown will be reinstalled. Patients will receive oral hygiene instructions and reinforcement.
干预措施: Non-Surgical Peri-Implant Therapy without Crown (Procedure)
Non-surgical therapy without prosthetic crown removal
Implants allocated to this group will receive non-surgical peri-implant therapy with the prosthetic crown left in place. Mechanical debridement will be performed under local anesthesia using the same instruments and protocol as in the test group (sonic scaler, ultrasonic devices, and Gracey curettes), but with access limited by the presence of the restoration. Professional oral hygiene instructions and reinforcement will also be provided.
干预措施: Non-Surgical Peri-Implant Therapy with Crown (Procedure)
结局指标
主要结局
Peri-implant probing depth (PIPD)
时间窗: From enrollment to the end of treatment at 1 year
Change in mean peri-implant probing depth (PIPD) at the implant level (measured at 6 sites per implant) from baseline to 3, 6, and 12 months after crown removal.
次要结局
未报告次要终点
研究者
Michele Paolantonio
Full Professor
G. d'Annunzio University