Regenerative Treatment of Peri-implantitis: A Comparison of the Reinforced PTFE Mesh (RPM) and the Collagen Membrane in the Submerged Approach: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Probing depth measurements in millimeters
研究概览
简要总结
The purpose of this study is to study the use of a new type of d-PTFE membrane called reinforced PTFE Mesh (RPM) with dental surgery. The regenerative outcomes of RPM membranes and collagen membrane for surgical reconstructive treatment of peri-implantitis (gum disease around implants) will be compared.
详细描述
Peri-implantitis is an inflammatory response that leads to irreversible loss of implant supporting bone. This study will investigate the regenerative outcomes obtained with two membranes for surgical reconstructive treatment of peri-implantitis defects when the implant is submerged and primary wound closure is obtained. In one group the newly designed d-PTFE membrane with macropores, known as the RPM membrane will be utilized, which will be compared to the traditional collagen membrane used in the other group. The clinical, radiographic, and histologic outcomes for the regenerative treatment of peri-implantitis when utilizing the same bone graft in combination with either a collagen membrane or the RPM will be evaluated via a parallel-arm randomized controlled clinical trial.
32 patients with peri-implantitis will be recruited and randomized to receive peri-implantitis treatment with either a collagen membrane or an RPM membrane.
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
- 否
入选标准
- •Age ≥ 18 years
- •Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
- •Subjects having at least one dental implant with peri-implantitis according to the definition proposed by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018):
- •Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)
- •Correct 3-dimensional implant positioning, or buccal position ≤ 1 mm
- •Implants which have been in function for at least 6 months
排除标准
- •A clearly mal-positioned dental implant
- •Significant interproximal horizontal bone loss (more than 50% of implant fixture length)
- •A mobile dental implant
- •Presence of uncontrolled or untreated periodontal disease
- •More than 2 weeks usage of antibiotics in the past two months
- •Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).
- •Pregnant subjects or individuals attempting to get pregnant (self-reported)
- •Subjects smoking more than 10 cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
- •Subjects unable to maintain adequate oral hygiene (O'Leary plaque index more than 50%) (O'Leary et al., 1972)
- •Any other contraindications for undergoing periodontal surgery
研究组 & 干预措施
PTFE Mesh Membrane
A reinforced PTFE Mesh membrane will be used to cover the bone graft.
干预措施: Membrane placement with bone grafting (Procedure)
Collagen membrane
A collagen membrane will be used to cover the bone graft.
干预措施: Membrane placement with bone grafting (Procedure)
结局指标
主要结局
Probing depth measurements in millimeters
时间窗: About 5 weeks before baseline surgery and at 8.5 months after baseline surgery.
To compare probing depth measurements using a periodontal probe after peri-implantitis treatment
Bone measurements in millimeters
时间窗: Baseline and 8 months after baseline surgery
Bone measurements obtained from CBCT
次要结局
- Marginal bone levels in millimeters at the implant site(8 months after baseline surgery)
- Volumetric changes of grafted area in cubic millimeters(8 months after baseline surgery)
- Clinical attachment levels in millimeters(8 months after baseline surgery)
研究者
Muhammad Saleh
Clinical Assistant Professor, Periodontics and Oral Medicine
University of Michigan