Regenerative Treatment of Peri-Implantitis: Double Blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in peri-implant probing depth
研究概览
简要总结
The purpose of this experimental study in humans is to evaluate and compare, the regenerative therapy for the treatment of peri-implantitis using different bone substitutes and absorbable membranes with surgical therapy without the use of materials for regeneration.
详细描述
Specifics aims
- Compare radiographic and clinical results of guided bone regeneration (GBR) technique in the treatment of peri-implantitis using membrane and bone substitute (JHS HAP91 ® + JHS COL-HAP-91®) to surgical approach without bone substitutes.
- Compare the radiographic and clinical results of GBR with surgical therapy without biomaterials
- Evaluate radiographic changes in bone levels after GBR therapy.
- Evaluate changes in probing depth (PD) after GBR therapy.
- Evaluate the long term predictability of GBR and surgical therapy in the treatment of peri-implantitis.
Study Design This prospective clinical trial will recruit to clinical periodontal and peri-implant examination, individuals diagnosed with peri-implantitis who fit the eligibility criteria described below. After the clinical examination the individuals will receive oral hygiene instructions and those diagnosed with peri-implantitis will take implants standardized radiographic exams prior to surgery. Only circular and/or bowl-shaped bone defects will be selected for the study.
Sampling In this design the inclusion of at least 15 individuals is estimated for each experimental group when it performs a sample calculation with power of 90% and a significance level of 95% considering an outcome data from previous studies.
Individuals diagnosed with peri-implantitis will be recruited in two specialized private treatment centers and post graduation schools from June 2013 to June 2016. The total sample of 15 eligible implants with peri-implantitis per group will be treated (n total = 30).
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It will include individuals diagnosed with early to moderate peri-implantitis (probing depth between 5 and 10 mm) rehabilitated with implant supporting fixed prosthesis for at least 6 months. Due to the great variation in implants' length the probing depth can shows great variability. In this way it is complicated to establish a cutoff point to define the severity of the disease. So in order to minimize this limitation, the peri-implant bone defect should be angular or circular involving at least 3 threads and should not exceed 50% of the total length of the implant.
排除标准
- •Individuals with blood glucose more than 120 mg/dl or Insulin dependent diabetes
- •Individuals who have undergone treatment of peri-implant disease over the last 6 months
- •Individuals who used antibiotic therapy, for any reason, in the last 3 months
- •Individuals who have any systemic condition that prevents surgical treatment
- •Refusal to sign the informed consent
- •A history of local radiotherapy to the head and neck region
- •Pregnancy and lactation
- •Active, uncontrolled periodontal pathology of the remaining dentition
结局指标
主要结局
Changes in peri-implant probing depth
时间窗: one year and half. Pre-operative, after surgery: 6, 12 and 18 months
Peri-implant probing depth measured in millimeters with peri-implant probe
次要结局
- Changes in radiographic marginal bone level on standardized intraoral radiographs(One year and half. Pre operative and after surgery: immediatelly, 6, 12 and 18 months)
研究者
Mr. Sergio Diniz Ferreira
PhD student
Federal University of Minas Gerais