Longitudinal Study of Dental Implant Therapy in HIV Positive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
研究概览
简要总结
The purpose is to place implants in HIV positive and HIV negative patients then follow patients over 3 years period of time to evaluate how well dental implants perform in HIV positive patients versus HIV negative patients.
详细描述
This study will review the osseointegration of implant supported restorations in HIV positive and HIV negative patients, then follow patients over a 3 year period of time. The treatment outcome as measured according to Mish criteria for implant success. Patients will be examined at each interval for the presence of pain, infection, mobility, and radiographic bone height of each implant.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy enough to undergo the proposed therapy without compromise to existing health status
- •At least 19 years old
- •Able to read and understand written English without the aid of ad hoc interpretation
- •Able to cognitively understand the proposed study and therapy and possible prognoses
- •Able to consent for their own inclusion in the study.
- •Implant supported restorations are limited to the following edentulous areas: Mandibular arch (excluding 2nd and 3rd molar areas), Maxillary anterior and premolar areas
排除标准
- •Uncontrolled diabetes
- •Uncontrolled hypertension
- •Bisphosphonate user
- •Extraction site healed less than 6 months
- •Women pregnant or lactating at the time of enrollment
- •Previous malignant neoplasm
- •A known hypersensitivity to Titanium metal
- •Any medication/condition that in the opinion of the clinical investigators may adversely affect bone healing
- •Any indication of an inability to make autonomous decisions
结局指标
主要结局
Number of Implants Functioning in HIV Positive Subjects Compared to HIV Negative Subjects
时间窗: Baseline to 36 months after implant restoration complete
Dental implant supported restoration functioning in the mouth with no pain, no mobility, no infection and less than 50% bone loss around the implant site.
次要结局
- Peri-implant Health and Bone Maintenance as Measured by Radiographic Examination in HIV Positive Subjects Compared to HIV Negative Subjects(36 months after implant restoration)
研究者
Toni Neumeier
Associate professor
University of Alabama at Birmingham