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

Primary Purpose

Edentulous

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
implant-retained overdentures
Sponsored by
Chufan Ma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Prosthodontics,School of Stomatology,The Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

complete dentures

implant-retained overdentures

Arm Description

complete dentures will be provided for all subjects according to the standardized treatment protocol

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

Outcomes

Primary Outcome Measures

masticatory efficiency
masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software

Secondary Outcome Measures

Oral health related quality of life
Oral health related quality of life will be measured with the Oral Health Impact Profile 14(OHIP-14).
patients' satisfaction
patients' satisfaction will be assessed on visual analog scales (VAS)

Full Information

First Posted
July 3, 2016
Last Updated
April 18, 2020
Sponsor
Chufan Ma
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1. Study Identification

Unique Protocol Identification Number
NCT02846805
Brief Title
The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chufan Ma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
complete dentures
Arm Type
No Intervention
Arm Description
complete dentures will be provided for all subjects according to the standardized treatment protocol
Arm Title
implant-retained overdentures
Arm Type
Experimental
Arm Description
subjects will receive two-implant-retained overdentures in the mandible ,and continue wearing their complete denture in the maxilla
Intervention Type
Procedure
Intervention Name(s)
implant-retained overdentures
Intervention Description
subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.
Primary Outcome Measure Information:
Title
masticatory efficiency
Description
masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software
Time Frame
three months after restoration of the implant-retained overdenture
Secondary Outcome Measure Information:
Title
Oral health related quality of life
Description
Oral health related quality of life will be measured with the Oral Health Impact Profile 14(OHIP-14).
Time Frame
three months after restoration of the implant-retained overdenture
Title
patients' satisfaction
Description
patients' satisfaction will be assessed on visual analog scales (VAS)
Time Frame
three months after restoration of the implant-retained overdenture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chufan Ma
Phone
+86 29 84776128
Email
machufan@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chufan Ma
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chufan Ma
Phone
+86 29 84776128
Email
machufan@fmmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
secret

Learn more about this trial

The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

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