The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

Not Applicable

• Conditions: Edentulous
• Interventions: Procedure: implant-retained overdentures

• Registration Number: NCT02846805
• Lead Sponsor: Chufan Ma

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-07-03
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-27
• Primary Completion: 2018-07
• Status Verified: 2020-04
• Study Completion: 2020-04
• Last Update Submitted: 2020-04-18
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Being edentulous in the upper and lower jaw for at least 1 year
2. Dissatisfied or cannot function with their complete lower denture
3. Age between 40 and 75
4. Suitable bone quality as assessed radiographically (CBCT) according to Zarb's classification。

Exclusion Criteria

1. Physical and mental disabilities which interfere with the maintenance of implants;
2. Severe skeletal jaw discrepancies (class III)
3. Those who have already received or lost dental implants
4. Those who abuse drugs or alcohol
5. Smoking more than 10 cigarettes a day
6. Having received radiotherapy to the head and neck region for malignancies
7. Undergoing chemotherapy
8. On long-term therapy with steroids
9. immunosuppressants or biphosphonates
10. Insulin-dependent diabetic patients and uncontrolled onset diabetic patients
11. Those affected by chronic renal or liver disease
12. Systemic and local bone disorders and pathology
13. Serious cardiac and pulmonary disorders
14. Haemophilic disorders who are susceptible for increased bleeding and tendency for post-operative infections
15. Those who are at risk of developing bacterial endocarditis
16. Immune system compromised patients, including those with HIV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
implant-retained overdentures	implant-retained overdentures	subjects will receive two-implant-retained overdentures in the mandible ,and continue wearing their complete denture in the maxilla

Primary Outcome Measures

Name	Time	Method
masticatory efficiency	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China