- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846805
The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients (TIMOEP)
April 18, 2020 updated by: Chufan Ma
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chufan Ma
- Phone Number: +86 29 84776128
- Email: machufan@fmmu.edu.cn
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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
|
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
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
|
three months after restoration of the implant-retained overdenture
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral health related quality of life
Time Frame: 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).
|
three months after restoration of the implant-retained overdenture
|
patients' satisfaction
Time Frame: three months after restoration of the implant-retained overdenture
|
patients' satisfaction will be assessed on visual analog scales (VAS)
|
three months after restoration of the implant-retained overdenture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Chufan Ma, Air Force Military Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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