Surgical Reconstructive Treatment of Peri-Implantitis With or Without Simultaneous Soft Tissue Augmentation: a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects. More specifically, the control group will be a reconstructive approach (xenograft bone graft granules and collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). The test group will be the same, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to grafting materials.
Outcomes will include CAL, PD, MR, defect resolution, PI, BoP, SUPP, surgical characteristics, and patient-reported outcome measures, including an aesthetic self-evaluation.
详细描述
The study will aim to compare two modalities in the reconstructive treatment of peri-implantitis defects.
More specifically, the control group will be a "pure" reconstructive approach (xenograft bone graft granules and resorbable collagen membrane, BioOss and BioGide, Geistlich, Wolhusen). This is in accordance with gold standard practices of reconstructive therapy of peri-implant defects.
The test group will be treated with the same approach and materials, with the exception of an autologous sub-epithelial connective tissue palatal graft, sutured beneath the flap, which will be used in addition to the grafting materials. The graft will be harvested from the homolateral palate (molar region).
Outcomes will include clinical attachment level (CAL; primary outcome), probing depth (PD), mucosal recession (MR), defect resolution (a composite outcome defined as the simultaneous absence of PD > 5 mm, bleeding on probing [BOP] and/or suppuration [SUP], and bone level changes > 0.5 mm), plaque index (PI), BOP, suppuration on probing, suppuration on palpation, surgical duration, the Early Wound Healing Index (EHI), and patient-reported outcome measures (PROMs), including aesthetic self-evaluation.
PROMs will assess patients' perception of surgery, pain intensity, perceived swelling, perceived bleeding, and analgesic intake.
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
- None
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
- •· Be able and willing to provide consent and sign the informed consent form.
- •Be able and willing to comply with study procedures and follow-up appointments required by the study protocol.
- •Age>18 years
- •Presence of at least one implant affected with peri-implantitis, defined as the following con-dition: at least one site presenting peri-implant probing depth (PPD) >6 mm and simultane-ous presence of profuse BoP/SUP and a radiographically documented change in bone level greater than initial bone remodeling. In the likely event that a baseline radiographic image is absent, the bone level will be compared to where it would likely have been at the time of implant insertion and a difference of >3 mm from that level will be considered.
- •Implants in function (i.e. loaded) for at least 1 year.
- •Screw- and cement-retained suprastructures for both fixed and removable prostheses.
排除标准
- •Compromised systemic health which contraindicates the study procedures.
- •Pregnant or nursing women.
- •Cigarette smoking>5 per day
- •Systemic conditions compromising healing (i.e. diabetes mellitus). Patients with diabe-tes mellitus types I or II will be asked to provide information regarding their most re-cent HbA1c values. Only patients with HbA1c<7% will be enrolled.
- •Patients taking medications known to interfere with gingival or bone metabolism.
研究组 & 干预措施
Xenograft+collagen membrane
Reconstructive approach (Xenograft+collegen membrane)
干预措施: Peri-implantitis reconstructive surgery (Procedure)
Xenograft+collagen membrane+autologous soft tissue graft
Reconstructive approach (Xenograft+collegen membrane) plus soft tissue graft (autologous, harvested as FGG)
干预措施: Peri-implantitis reconstructive surgery (Procedure)
结局指标
主要结局
Clinical attachment level
时间窗: change from baseline to: 6, 12, 18, 24 months
linear distance (mm) from the implant platform to the bottom of the pocket
次要结局
- Gingival thickness(6, 12, 18, 24 months)
- Probing depth(6, 12, 18, 24 months)
- profuse bleeding(6, 12, 18, 24 months)
- Disease resolution(6, 12, 18, 24 months)
- plaque index (minimum value 0, maximum 1)(6, 12, 18, 24 months)
- BOP(6, 12, 18, 24 months)
- Patient-reported outcome measures(6, 12, 18, 24 months)
- Mucosal recession(6, 12, 18, 24 months)
- suppuration(6, 12, 18, 24 months)
- Radiographic bone levels(2 weeks, 12 months, 24 months)
研究者
Lucrezia Paternò Holtzman
Investigator
George Eastman Dental Hospital, Italy