The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

NCT ID: NCT02846805

Last Updated: 2020-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-04-30

Brief Summary

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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

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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.

Conditions

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Edentulous

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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complete dentures

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

Group Type NO_INTERVENTION

No interventions assigned to this group

implant-retained overdentures

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

Group Type EXPERIMENTAL

implant-retained overdentures

Intervention Type PROCEDURE

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

Interventions

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implant-retained overdentures

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chufan Ma

OTHER

Sponsor Role lead

Responsible Party

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Chufan Ma

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chufan Ma

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chufan Ma

Role: CONTACT

+86 29 84776128

Facility Contacts

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Chufan Ma

Role: primary

+86 29 84776128

Other Identifiers

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IRB-REV-2016035

Identifier Type: -

Identifier Source: org_study_id

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