Reconstructive Surgical Treatment of Peri-implant Intra-osseous Defects - A MULTICENTER RANDOMIZED PROSPECTIVE CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- changes in radiographic bone level (mm)
研究概览
简要总结
The purpose of this randomized trial was to compare reconstructive surgery of advanced peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap debridement (OFD/Control) in a non-submerged technique over 6 months.
详细描述
Scientific rationale for study:
There is a paucity of data for the effectiveness of reconstructive procedures in the treatment of peri-implantitis. Recently, titanium brushes have been introduced for implant surface debridement and porous titanium granules (PTG) as an osteoconductive bone substitute.
Study design The study was designed as a prospective multicentre, multi-national, randomized, parallel group-controlled clinical trial of 6 months duration.
All participating investigators attended training and calibration meetings to discuss and optimize patient accrual and retention as well as data management. Preliminary clinical cases were discussed to standardize case selection, the measurement techniques and surgical procedures. On-site rules, for the compilation of the data collection sheets for appropriate oversight were frequently reassured by a study monitor to ensure the validity of the data.
Open flap debridement and surface decontamination with titanium brush (n = 30/Control), or additional insertion of PTG (n=33/Test) was performed for reconstruction of 3- or 4-wall intra-osseous peri-implant defects with at least 3 mm defect depth and circumferential (≥270°) morphology. Patients were given amoxicillin and metronidazole for 8 days. Radiographic and clinical assessments were performed at baseline and 6 months.
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 (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
- 否
入选标准
- •All implants had to be in function for more than 12 months. Only one implant per patient was included in the study.
- •Primary inclusion criteria
- •By initial radiographic evaluation:
- •Intraosseous defect ≥ 3 mm defect depth on standard intraoral radiograph.
- •By clinical evaluation:
- •Peri-implant probing depth (PD) ≥ 5 mm
- •Bleeding (BOP) and/or suppuration (PUS)
- •Secondary inclusion criteria
- •By intra-operative exploration:
- •Intra-osseous defect component ≥ 3 mm at the deepest point
- •3 to 4 wall intra-osseous
- •Osseous defect with at least 270 degrees (circumferential)
- •Defect angle ≤ 35 degrees (from axis of implant)
排除标准
- •Subjects with diabetes mellitus (HbA1c ≥6.5)
- •Subjects taking corticosteroids or other anti-inflammatory prescription drugs.
- •Subjects taking medications known to induce gingival hyperplasia
- •Subjects with a history of taking systemic antibiotics in the preceding month.
- •Patients pregnant or nursing
- •Implants placed in grafted bone or previously augmented with bone /bone substitute or other type of regenerative material
- •Implants previously surgically treated for peri-implantitis
- •Failure to obtain soft tissue closure
- •Mobile implant
研究组 & 干预措施
Tigran PTG
Surgical intervention: open flap debridement and implantation of bone grafting material
干预措施: Tigran PTG (Device)
Tigran PTG
Surgical intervention: open flap debridement and implantation of bone grafting material
干预措施: Surgical intervention (Procedure)
Control
Surgical intervention: open flap debridement
干预措施: Surgical intervention (Procedure)
结局指标
主要结局
changes in radiographic bone level (mm)
时间窗: baseline and 6 month after treatment
次要结局
- % radiographic defect fill(baseline and 6 month after treatment)
- Bleeding on Probing (BoP)(baseline and 6 month after treatment)
- % radiographic defect resolution(baseline and 6 month after treatment)
- Pocket Probing Depth (PPD)(baseline and 6 month after treatment)
- Plaque(baseline and 6 month after treatment)
- Suppuration (PUS)(baseline and 6 month after treatment)