The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

Edentulous Clinical Trial

— TIMOEP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02846805
• Other study ID #: IRB-REV-2016035
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Fourth Military Medical University
• Contact: Chufan Ma
• Phone: +86 29 84776128
• Email: machufan[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: April 2020
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous
• Mouth, Edentulous

Intervention

Procedure:
• implant-retained overdentures
subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.

Locations

Country	Name	City	State
China	Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chufan Ma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	patients' satisfaction	patients' satisfaction will be assessed on visual analog scales (VAS)	three months after restoration of the implant-retained overdenture