The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

NCT02846805 | Unknown DMC

• 1 other identifier: IRB-REV-2016035
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Oral health related quality of life

  three months after restoration of the implant-retained overdenture

• patients' satisfaction

  three months after restoration of the implant-retained overdenture

Study Arms (2)

complete dentures

NO INTERVENTION

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

implant-retained overdentures

EXPERIMENTAL

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

Procedure: implant-retained overdentures

Interventions

implant-retained overdentures PROCEDURE

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

implant-retained overdentures

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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。

You may not qualify if:

• 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

Sponsors & Collaborators

• Chufan Ma: lead

Study Sites (1)

Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Chufan Ma

  Air Force Military Medical University, China

  STUDY CHAIR

Central Study Contacts

Chufan Ma

CONTACT

+86 29 84776128; machufan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 27, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: April 1, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)