A Clinical Trial on Conventional Dentures and Implant-retained Mandibular Overdentures With Respect to Oral Functionality and Quality of Life in Edentulous Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- masticatory efficiency
研究概览
简要总结
The purpose of this study is to investigate to what extent IOs improve the functionality of edentulous patients and changes in quality of life and overall patient satisfaction following treatment with IOs.
详细描述
Edentulous individuals will be selected from patients attending the prosthodontic clinic. Then, new complete dentures will be provided; in a second stage half of these subjects (randomly selected) will receive IOs. The effect of different treatment protocols on chewing ability, patient satisfaction and OHRQoL will be investigated and assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being edentulous in the upper and lower jaw for at least 1 year
- •Dissatisfied or cannot function with their complete lower denture
- •Age between 40 and 75
- •Suitable bone quality as assessed radiographically (CBCT) according to Zarb's classification。
排除标准
- •Physical and mental disabilities which interfere with the maintenance of implants;
- •Severe skeletal jaw discrepancies (class III)
- •Those who have already received or lost dental implants
- •Those who abuse drugs or alcohol
- •Smoking more than 10 cigarettes a day
- •Having received radiotherapy to the head and neck region for malignancies
- •Undergoing chemotherapy
- •On long-term therapy with steroids
- •immunosuppressants or biphosphonates
- •Insulin-dependent diabetic patients and uncontrolled onset diabetic patients
- •Those affected by chronic renal or liver disease
- •Systemic and local bone disorders and pathology
- •Serious cardiac and pulmonary disorders
- •Haemophilic disorders who are susceptible for increased bleeding and tendency for post-operative infections
- •Those who are at risk of developing bacterial endocarditis
- •Immune system compromised patients, including those with HIV
结局指标
主要结局
masticatory efficiency
时间窗: three months after restoration of the implant-retained overdenture
masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software
次要结局
- Oral health related quality of life(three months after restoration of the implant-retained overdenture)
- patients' satisfaction(three months after restoration of the implant-retained overdenture)
研究者
Chufan Ma
Associate professor
Air Force Military Medical University, China