Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Successful Treatment of Peri-Implantitis
研究概览
简要总结
The objective of the present randomized clinical trial will be to compare two surgical methods of treating peri-implantitis. This study will determine if surgical debridement of peri-implantitis bone defects, including air powder abrasive (APA) decontamination of implant surfaces, in combination with the placement of a bone graft, differs in treatment outcomes compared to placing the same bone graft material with a resorbable collagen membrane placed over the bone graft.
详细描述
The purpose of the study is to compare treatment outcomes of peri-implantitis defects when using a defect fill substitute (InterOss Collagen), against the treatment outcome when placing the same defect fill substitute with a resorbable collagen membrane (InterCollagen Guide). There is no current literature to suggest that placing a collagen membrane over a bone grafting material in an infrabony defect of more than 270 degrees is more effective than placing the bone graft material alone. The present study will help in understanding if such defects require an additional placement of a collagen membrane which could increase the cost of the procedure for the practitioner and the patient.
The study will be conducted at the University of Pittsburgh School of Dental Medicine Graduate Periodontics Department. A detailed description of research activities during each patient visit is provided below.
Screening Visit (V0):
Prior to starting any of the procedures, the subject will complete the informed consent interview. Patients will be screened to assess for inclusion in the study. Vitals (blood pressure and heart rate) will be measured and medical history will be discussed. Limited field of view (FOV) cone beam computed tomography (CBCT) scan will be taken and examined prior to the study to determine the presence of a 270 degree circumferential boney defect for inclusion in the study. Probing pocket depths (PPD), plaque sites, mobility and bleeding on probing (BOP) are clinical measurements that will be completed. The visit will take approximately 1.5 hours. All procedures will be performed by the faculty and Periodontics graduate resident.
Pre-surgical phase (V1):
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
- •To be enrolled, the participant must meet the following inclusion criteria:
- •age 18 years or older
- •be patients of record at the University of Pittsburgh Periodontics Department
- •Systemically healthy patients
- •Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at six sites per tooth)
- •Study individuals will be included if they met the following criteria: (a) one or more peri-implant sites with PPD ≥6 mm combined with BOP/suppuration, and (b) peri-implant marginal bone loss, defined as a crater like defect ≥3 mm as assessed from intra- oral radiographs, (c) Infrabony circumferential defect of more than 270° determined by CBCT, (d) crown not possible to retrieve before surgery
排除标准
- •study individuals will be excluded if any of the folllowing apply:
- •Unlikely to be able to comply with study procedures and unable to return to SDM for multiple appointments over the course of about a year.
- •Uncontrolled pathologic processes in the oral cavity (cancer and active periodontal disease)
- •History of allergic reactions to dental local anesthetics
- •History of head and neck chemotherapy or radiation within 5 years prior to surgery
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, such as HIV infection, Paget's disease, osteoporosis, etc.
- •Reported diagnosis of diabetes mellitus
- •Patients taking corticosteroids, IV bisphosphonates, or any immunosuppressant medication that could influence post-operative healing and/or osseointegration
- •Smokes more than 10 cigarettes/day (self-reported)
- •History or current medications with known side effects of gingival growth (including any of the following: phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, diltazem, amlodipine, felodipine, verapamil, cyclosporine).
- •Present alcohol and/or drug abuser (self-reported)
- •Pregnant, unsure pregnancy status, or lactating females (self-reported), or planning to become pregnant within 1 year of study enrollment
研究组 & 干预措施
Bone grafting with collagen membrane
This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with a collagen membrane (InterCollagen Guide) placed over the bone graft.
干预措施: InterOss Collagen (Bone xenograft) and InterOss Collagen Guide (Collagen membrane) (Procedure)
Bone grafting without collagen membrane
This arm will receive surgical intervention involving placement of a bone xenograft subsitute (InterOss Collagen) into the peri-implant bone defect with no collagen membrane placed over the graft.
干预措施: InterOss Collagen (Bone xenograft) (Procedure)
结局指标
主要结局
Successful Treatment of Peri-Implantitis
时间窗: 5 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 60 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
时间窗: 1 year
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 12 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
时间窗: 2 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 24 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
时间窗: 3 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 36 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
Successful Treatment of Peri-Implantitis
时间窗: 4 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 48 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
次要结局
- Radiographic Marginal Bone Loss (MBL)(12 months)
- Peri-Implant Bleeding on Probing(12 months)
- Peri-Implant Probing Depth(12 months)
- Clinical Peri-Implant Bone Defect Fill(4 months)
- Clinical Peri-Implant Bone Defect Resolution(4 months)
- Patient Reported Pain Outcomes(4 weeks)
- Radiographic Marginal Bone Loss (MBL)(8 months)
- Peri-Implant Bleeding on Probing(8 months)
- Peri-Implant Probing Depth(8 months)
研究者
Andrea Ravida
Periodontics Program Director
University of Pittsburgh