The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients (TIMOEP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Edentulous
• Intervention / Treatment: Procedure: implant-retained overdentures

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 Type: Interventional
• Enrollment (Anticipated): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University
      • Contact: Chufan Ma; Phone Number: +86 29 84776128; Email: machufan@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Chufan Ma
• Investigators: Study Chair: Chufan Ma, Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: July 3, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: IRB-REV-2016035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: secret