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Status unknownNCT02846805TIMOEPUpdated Apr 21, 2020

The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients

An interventional study of implant-retained overdentures in Edentulous, sponsored by Chufan Ma. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Chufan Ma · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Edentulous

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03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's planned enrollment of 53 is above the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

This is the only study on the registry with Chufan Ma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
53 participants (estimated)

Study arms

  • 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

Interventions

  • Procedureimplant-retained overdentures

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

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What researchers measure

Primary outcomes

  1. masticatory efficiency

    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 outcomes

  1. Oral health related quality of life

    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

  2. patients' satisfaction

    patients' satisfaction will be assessed on visual analog scales (VAS)

    Time frame: three months after restoration of the implant-retained overdenture

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Study locations

1 of 1 sites recruiting
  • Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University
    Xi'an, Shaanxi 710032, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No — secret

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02846805
Lead sponsor
Chufan Ma
Responsible party
Chufan Ma (Associate professor, Air Force Military Medical University, China) — Sponsor-investigator
First posted
Jul 27, 2016
Start date
May 2016
Primary completion
Jul 2018
Completion
Apr 2020 (estimated)
Last update
Apr 21, 2020

Study contacts

Chufan Ma
Contact
machufan@fmmu.edu.cn
+86 29 84776128
Chufan Ma
study chair · Air Force Military Medical University, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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