EdentulousTIMOEPNCT02846805
The Treatment of Implant-retained Mandibular Overdentures for Edentulous Patients
A study testing implant-retained overdentures in people with Edentulous, run by Chufan Ma at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- implant-retained overdentures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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。
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Prosthodontics,School of Stomatology,The Fourth Military Medical University
Xi'an, Shaanxi, 710032
Chufan Ma, +86 29 84776128, machufan@fmmu.edu.cn
About this study
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
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.
- Conditions
- Edentulous
- Being tested
- implant-retained overdentures
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant-retained overdenturesProcedure or surgery
subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: implant-retained overdentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
masticatory efficiency
masticatory efficiency will be measured with chwing-gum ,and the outcome will be analysed with the viewgum software
Measured: three months after restoration of the implant-retained overdenture
Secondary outcomes (2)
Oral health related quality of life
Oral health related quality of life will be measured with the Oral Health Impact Profile 14(OHIP-14).
Measured: three months after restoration of the implant-retained overdenture
patients' satisfaction
patients' satisfaction will be assessed on visual analog scales (VAS)
Measured: three months after restoration of the implant-retained overdenture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2018
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chufan Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chufan Ma, Air Force Military Medical University, China
- Investigators
- Chufan Ma, Study chair, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846805
- Sponsor's protocol ID
- IRB-REV-2016035
- Acronym
- TIMOEP
- Status last verified
- Apr 2020
- First submitted
- 3 Jul 2016
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: secret
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02846805
- Acronym / sponsor ID
- TIMOEP / IRB-REV-2016035
- Conditions
- Edentulous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Chufan MaUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Apr 2020 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complete dentures | No intervention | –complete dentures will be provided for all subjects according to the standardized treatment protocol |
| implant-retained overdentures | Experimental | Procedure: implant-retained overdenturessubjects will receive two-implant-retained overdentures in the mandible ,and continue wearing their complete denture in the maxilla |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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。
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implant-retained overdenturessubjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla. | Procedure or surgery | implant-retained overdentures |
Primary outcome
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
2 secondary outcomes
Oral health related quality of life
Time frame: three months after restoration of the implant-retained overdenture
patients' satisfaction
Time frame: three months after restoration of the implant-retained overdenture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No. secret
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chufan Ma study chair
Air Force Military Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant-retained overdentures in people with Edentulous, run by Chufan Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chufan Ma (+86 29 84776128, machufan@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
masticatory efficiency (time frame: three months after restoration of the implant-retained overdenture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.