Medium-term Follow-up of a Randomised Controlled Study Evaluating Reconstructive Peri-implantitis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- success
研究概览
简要总结
This study is a medium-term (6-9 years) follow-up of the health of the tissues surrounding the implant which was treated for peri-implantitis (peri-implant infection) in an already completed study with a 12 month follow-up. Patients who were treated in a randomised controlled trial with a 12 month follow-up will be invited to attend for examination of the implant and an x-ray to assess the bone levels at the implant. Participants will be asked to complete a questionnaire about their overall satisfaction following treatment.
详细描述
Follow-up of 40 participants who were already enrolled in a randomised controlled trial comparing access flap with and without guided bone regeneration for the treatment of peri-implantitis. The 12 month outcomes have been published. doi: 10.1111/clr.14116 This study will provide a medium term (6-9 years) follow-up of the participants Participants will be invited to attend an examination.
Full mouth probing Full mouth bleeding and plaque scores Peri-implant probing depth and recession measurements at the treated implant An intraoral radiograph to evaluate marginal bone levels at the treated implant Questionnaire to evaluate satisifaction with the treatment
Participants will receive maintenance care at the treated implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants from the previous study ID 37382408
- •participants from the previous study who were treated for peri-implantitis either with access flap or access flap and graft material + barrier membrane.
排除标准
- •- individuals who were not enrolled in the previous study ID 37382408
研究组 & 干预措施
participants who have received surgical peri-implantitis treatment
6 -9 year follow-up after treatment of peri-implantitis
干预措施: Medium-term follow-up of peri-implantitis treatment (Other)
结局指标
主要结局
success
时间窗: minimum 6 years
implant present + peri-implant probing depths ≤ 5 mm + absence of bleeding BOP ( 1 spot of bleeding allowed) + suppuration + no additional bone loss
Number of implants with peri-implant health
时间窗: minimum 6 years
implant present + peri-implant probing depths ≤ 5 mm + absence of bleeding BOP ( 1 spot of bleeding allowed) + absence suppuration + no additional bone loss as compared to baseline measures
次要结局
- bleeding on probing(minimum 6 years)
- probing depth (mm)(minimum 6 years)
- suppuration(minimum 6 years)
- mucosal recession (mm) change from prior to treatment(minimum 6 years)
- radiographic marginal bone level compared to bone level pre-treatment(minimum 6 years)
- patient reported outcomes(minimum 6 years)
- radiographic marginal bone level compared to 12 month marginal bone level(minimum 6 years)
- peri-implant probing depth (mm)(minimum 6 years)
- peri-implant bleeding on probing (presence or absence)(minimum 6 years)
- peri-implant suppuration (presence or absence)(minimum 6 years)
- peri-implant mucosal recession (mm)(minimum 6 years)
- radiographic marginal bone level (mm) compared to bone level at baseline(minimum 6 years)
- patient reported outcomes on VAS scale 0 - 100 mm(minimum 6 years)
- radiographic marginal bone level ( mm) compared to 12 month marginal bone level(minimum 6 years)
研究者
Lisa Heitz-Mayfield
Adjunct Professor
The University of Western Australia