The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

Study 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.

Official Title
-----------------
A Clinical Trial on Conventional Dentures and Implant-retained Mandibular Overdentures With Respect to Oral Functionality and Quality of Life in Edentulous Patients

Conditions
-----------------
Edentulous

Intervention / Treatment
-----------------
* Procedure: implant-retained overdentures


Participation Criteria
=================
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 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: complete dentures<br>complete dentures will be provided for all subjects according to the standardized treatment protocol | |
| Experimental: implant-retained overdentures<br>subjects will receive two-implant-retained overdentures in the mandible ,and continue wearing their complete denture in the maxilla | Procedure: implant-retained overdentures<br>* subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| masticatory efficiency | masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software | three months after restoration of the implant-retained overdenture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health related quality of life | Oral health related quality of life will be measured with the Oral Health Impact Profile 14(OHIP-14). | three months after restoration of the implant-retained overdenture | 
| patients' satisfaction | patients' satisfaction will be assessed on visual analog scales (VAS) | three months after restoration of the implant-retained overdenture |