EdentulousNCT02850458
Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients
An observational study of Edentulous, run by Ji-hua Chen at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients. Read more about this study
- Who is it for?
- Ages 45 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- implant-retained overdentures
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Aug 2017
- Phase
- Observational
- 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 45 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients treated with implant retained overdentures at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between July 2011 to May 2014.
Who may be able to join
- Patients treated with implant retained overdentures
- With the ability to read and sign the informed consent document
Who cannot join
- Jaw radiotherapy treatment before and after implanting
- Patients who suffered with mental and psychological disease will influence their oral health normal maintenance
- Can not read and sign the informed consent document
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Stomatological Hospital of Fourth Military Medical University
Xi’an, Shanxi
ji hua chen, PhD, 029-84776329, jhchen@fmmu.edu.cn
huan zhou, 029-84776128, zhouhuan113@126.com
About this study
Official title: Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study
The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.
Read the detailed description
The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires.
- 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 overdenturesDevice
patients treated with an implant-retained overdenture in the mandible
| Study group | Role | What they receive |
|---|---|---|
| implant retained-overdentures with the attachment of bar | patients treated with implant-retained overdentures,and the attachment is bar Receives: Device: implant-retained overdentures | |
| implant retained-overdentures with the attachment of magnet | patients treated with implant-retained overdentures,and the attachment is magnet Receives: Device: implant-retained overdentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of implants
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Gingival Bleeding on Probing
Gingival bleeding on probing (BOP) using the modified sulcus bleeding index for implants. Scale equals 0 = No bleeding when periodontal probe is passed along the gingival margin;1 = Isolated bleeding spots visible;2 = Blood forms a confluent red line on the gingival margin;3 = Heavy or profuse bleeding
Measured: through study completion, an average of 1 year
Pocket depths
Pocket depths measured around implants in millimeter (mm)
Measured: through study completion, an average of 1 year
Marginal bone loss
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionAug 2017 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji-hua Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji-hua Chen, Air Force Military Medical University, China
- Investigators
- Yong jin chen, Principal investigator, IRB of Stomatological Hospital of FMMU,PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850458
- Sponsor's protocol ID
- IRB-REV-2016036
- Status last verified
- Feb 2017
- First submitted
- 25 Jul 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study
- ClinicalTrials.gov ID
- NCT02850458
- Acronym / sponsor ID
- IRB-REV-2016036
- Conditions
- Edentulous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ji-hua ChenUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 1 Aug 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 evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.
Detailed description
The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant retained-overdentures with the attachment of bar | – | Device: implant-retained overdenturespatients treated with implant-retained overdentures,and the attachment is bar |
| implant retained-overdentures with the attachment of magnet | – | Device: implant-retained overdenturespatients treated with implant-retained overdentures,and the attachment is magnet |
Who may qualify
- Ages
- 45 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with implant retained overdentures at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between July 2011 to May 2014.
Key inclusion criteria (2 listed)
- Patients treated with implant retained overdentures
- With the ability to read and sign the informed consent document
Key exclusion criteria (3 listed)
- Jaw radiotherapy treatment before and after implanting
- Patients who suffered with mental and psychological disease will influence their oral health normal maintenance
- Can not read and sign the informed consent document
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 overdenturespatients treated with an implant-retained overdenture in the mandible | Device | implant retained-overdentures with the attachment of bar, implant retained-overdentures with the attachment of magnet |
Primary outcome
Survival of implants
Time frame: through study completion, an average of 1 year
3 secondary outcomes
Gingival Bleeding on Probing
Time frame: through study completion, an average of 1 year
Pocket depths
Time frame: through study completion, an average of 1 year
Marginal bone loss
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Yes
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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.
Yong jin chen principal investigator
IRB of Stomatological Hospital of FMMU,PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous, run by Ji-hua Chen 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 2 inclusion and 3 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 7 Feb 2017. 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 Ji hua chen, PhD (029-84776329, hchen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of implants (time frame: through study completion, an average of 1 year). 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 7 Feb 2017.