Assessment of the Accuracy of the Clinical Parameters and Radiographs in Determining the Topography of Implant Bony Lesions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Absolute change from baseline of probing pocket depth (PPD in mm) and the degree of bone fill at re-entry (6 months)
研究概览
简要总结
In recent years, dental implants have gained popularity as the treatment choice for replacement of missing teeth. With this, one of the late biological complications that arise is peri-implantitis. Based on a consensus conference in 2008, peri-implantitis was found in 28% and ≥ 56% of subjects and in 12% and 43% of implant sites (Zitzmann & Berglundh 2008). Detection of peri-implantitis is currently based on clinical parameters like probing depths and radiographic findings of bone loss. There is however no study that assess the variability of clinical probing and radiographic reading in relation to the true outline of the peri-implantitis lesion. The present study will measure variability of clinical probing and radiographs in relation to the true outline of the peri-implantitis lesion, as well as assess the use of 2 different bone substitutes in regenerating the lesions with a barrier membrane.
详细描述
Identification of peri-implant bony lesions by clinical parameters or radiographs alone may sufficiently reflect the topographical outline of a peri-implant bony lesion. To date, no comparative studies are available that identify the accuracy of clinical parameters or radiographs in outlining the extent and the severity of the lesion. If these parameters are of sufficient accuracy, surgical procedures to regenerate the lesion may be more predictable to plan.
The study population will be patients undergoing regular implant maintenance care in the National Dental Centre Singapore, Periodontics Unit, Department of Restorative Dentistry and yielding peri-implantitis (residual probing depths ≥6mm and bleeding on probing, bone loss of ≥2mm documented on periapical radiographs).
In the first part of the study, the variability of the clinical parameters and periapical radiographs will be assessed and compared to the actual bony lesions revealed after surgical access. This prospective cohort study will encompass 24 subjects. In the second part of the study, a randomised controlled clinical trial will be staged exploring the clinical outcomes of regenerative therapy of the peri-implant lesions applying 2 different bone substitutes with a barrier membrane for the principle of guided bone regeneration (GBR).
First part of study:
The null hypothesis is that of no difference in the mesial and distal radiographic readings as compared to the measurement obtained by clinical probing of the actual peri-implant lesions. The null hypothesis is also that of no difference between probing depth measurements and the actual lesions measured under open access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically healthy adults (ASA classification I-II), at least 21 years of age.
- •Diagnosed with peri-implantitis (at least one site with PPD of ≥ 6 mm, a positive bleeding on probing (BOP) and radiographic bone loss of ≥ 2 mm).
- •Had non-surgical therapy performed previously
- •Ability to comply with 6-month study follow-up.
排除标准
- •Medically compromised subjects (ASA classification III-V).
- •Had not gone through non-surgical therapy
- •Known allergy or other severe adverse reactions to the synthetic membrane and bone substitutes.
- •Self declared pregnancy or intend to conceive.
结局指标
主要结局
Absolute change from baseline of probing pocket depth (PPD in mm) and the degree of bone fill at re-entry (6 months)
时间窗: 6 months after GBR
- To determine: 1. Absolute change from baseline of probing pocket depth (PPD in mm) 6 months following GBR therapy in test and control 2. The degree of bone fill at re-entry (6 months), as well as radiographically (in mm) following GBR
The accuracy of clinical probing pocket depths to the true outline in peri-implantitis lesions
时间窗: 6 months after GBR
To determine the accuracy of clinical probing pocket depths (in mm) to the true outline in peri-implantitis lesions
The accuracy of peri-apical radiographic readings to the true outline in peri-implantitis lesions
时间窗: 6 months after GBR
To determine the accuracy of peri-apical radiographic readings (in mm) to the true outline in peri-implantitis lesions
次要结局
未报告次要终点
研究者
Tan Wah Ching
Dr, Visiting Specialist (Peridontics), Department of Restorative Dentistry
National Dental Centre, Singapore