Mechanical Treatment of Peri-Implant Mucositis -the Effect of Submucosal Instrumentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Bleeding on probing (BoP) extent
研究概览
简要总结
This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.
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 (Investigator)
盲法说明
Investigator-blinded
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be ≥ 20 years
- •Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of <2mm from the top of the intraosseous part of the implant is considered as the reference threshold)
- •Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus).
- •No evidence of occlusal overload
- •No cement remnants identified on radiographs or clinically
- •Implant-supported fixed restoration inserted at least 6 months before patient enrolment and not interfering with assessment of clinical parameters at more than 3/6 sites
- •Periodontally healthy subjects or treated periodontitis (no residual site with PPD ≥ 5 mm)
- •Full-mouth plaque (FMPS) and bleeding (FMBS) score ≤ 20%¬¬¬¬¬¬¬ at screening visit
- •Non-smokers or light-smokers (<10 cigarettes per day)
- •Competent to give consent
排除标准
- •Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment
- •Hematologic disorders
- •Pregnant subjects
- •Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
- •No systemic antibiotic treatment within 3 months prior to intervention
结局指标
主要结局
Bleeding on probing (BoP) extent
时间窗: 6 months
Reduction in the extent of BoP as measured on six sites per implant
次要结局
- Peri-implant sulcus fluid (PISF) biomarkers(6 months)
- Intraoral digital scan(6 months)
- Severity of BoP(6 months)
- Disease resolution(6 months)
- Probing pocket depth (PPD) reduction(6 months)
- Bone level changes(6 months)
- Onset of peri-implantitis(6 months)
研究者
Anders Verket
Principal investigator
University of Oslo