A Clinical Trial on Conventional Dentures and Implant-retained Mandibular Overdentures With Respect to Oral Functionality and Quality of Life in Edentulous Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Edentulous
- Sponsor
- Chufan Ma
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- masticatory efficiency
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Chufan Ma
Associate professor
Air Force Military Medical University, China
Eligibility Criteria
Inclusion Criteria
- •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。
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
masticatory efficiency
Time Frame: 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
Secondary Outcomes
- 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)