Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Changes marginal bone level
研究概览
简要总结
Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high.
Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.
详细描述
The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:
Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.
Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.
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 (Investigator, 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
- •Age ≥18 years.
- •Systemically healthy patients.
- •Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component.
- •Absence of mobility of the implants.
- •Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded).
- •Patient's smoking ≤ 10 cigarettes/day.
排除标准
- •Non-removable prostheses
结局指标
主要结局
Changes marginal bone level
时间窗: baseline, 6 and 12 months
measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.
次要结局
- Change Keratinized mucosa(baseline, 6 and 12 months)
- Change blending on probing(baseline, 6 and 12 months)
- Change plaque score(baseline, 6 and 12 months)
- Change Reccesion(baseline, 6 and 12 months)
- Changes Clinical attachment level(baseline, 6 and 12 months)
- Changes Probing pocket depth(baseline, 6 and 12 months)
- Change supuration(baseline, 6 and 12 months)
- configuration of the bone defect(baseline)
研究者
Juan Blanco Carrión
Principal investigator - Juan Blanco Carrión
University of Santiago de Compostela