Surgical Peri-implantitis Treatment With and Without Implantoplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Bleeding on probing
研究概览
简要总结
This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis.
Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
- •Competent to give consent
- •Exposed, modified implant surface with loss >2mm
排除标准
- •Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
- •Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
- •Patients classified as > class II according to ASA classification
- •Implant unavailable for implantoplasty treatment
- •Inhability to comprehend and respond to the quality of life questionnaire
- •Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
- •History of peri-implantitis surgery prior to 6 months of screening
研究组 & 干预措施
Peri-implantitis treatment without implantoplasty
Open flap debridement withput implantoplasty treatment
干预措施: Open flap debridement alone (Procedure)
Peri-implantitis treatment with implantoplasty
Open flap debridement with implantoplasty treatment
干预措施: Implantoplasty (Procedure)
Peri-implantitis treatment with implantoplasty
Open flap debridement with implantoplasty treatment
干预措施: Open flap debridement alone (Procedure)
Peri-implantitis treatment without implantoplasty
Open flap debridement withput implantoplasty treatment
干预措施: Implantoplasty (Procedure)
结局指标
主要结局
Bleeding on probing
时间窗: 24 months after treatment
Measured with a periodontal probe
Bleeding on probing
时间窗: 12 months after treatment
Measured with a periodontal probe
次要结局
- Clinical attachment loss measurements(24 months after treatment)
- Radiographic bone loss(24 months after treatment)
- Implant fracture(24 months)
- Suppuration(24 months after treatment)
- Pocket probing depth(24 months after treatment)
- Changes in patient-reported quality of life (QoL)(Preoperatively compared to 24 months after treatment)
- Suppuration(12 months after treatment)
- Pocket probing depth(12 months after treatment)
- Clinical attachment loss measurements(12 months after treatment)
- Radiographic bone loss(12 months after treatment)
研究者
Anders Verket
Associate Professor
University of Oslo