Jaw, Edentulous, PartiallyNCT02676661
Evaluation of the Prevalence and Risk Factors for Patients With Peri-implant Disease
An observational study of Jaw, Edentulous, Partially, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2022
- How long will I take part?
- 5 Years
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Partially edentulous patients implant dental implants and will be restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University
Who may be able to join
- Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.
Who cannot join
- Jaw radiotherapy treatment before and after implanting. Patients who have bruxism,xerostomia or the adjacent teeth periapical periodontitis.
- Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.
- Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Stomatological Hospital of Fourth Military Medical University
Xi’an, Shanxi, 710032
Min Tian, PhD, +86 13891862298, tianminno1@163.com
Jihua Chen, PhD, +86 13991390388, jhchen@fmmu.edu.cn
About this study
Official title: The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study
To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.
Read the detailed description
The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- peri-implant disease, risk factors, prevalence
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| no peri-implant disease | The subjects who did not suffer from peri-implant disease. | |
| peri-implant disease | The subjects who suffered from peri-implant disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant disease
Peri-implant disease includes Peri-implant mucositis and Peri-implantitis.Peri-implant mucositis: BoP/suppuration but no detectable bone loss. Peri-implantitis: BoP/suppuration and bone loss >2 mm.
Measured: at the 5 years after prosthetic loading.
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: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Pocket depths
PD will be measured from the free gingival margin to the base of the pocket and will be recorded in whole millimeters (mm).
Measured: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Marginal bone loss
Marginal bone loss will be assessed by periapical radiographs taken with the paralleling technique.
Measured: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-hua Chen, Air Force Military Medical University, China
- Investigators
- Yongjin Chen, PhD, Principal investigator, IRB of Stomatological Hospital of FMMU,PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676661
- Sponsor's protocol ID
- Jhchen
- Status last verified
- Jan 2016
- First submitted
- 24 Jan 2016
- Last updated
- 8 Feb 2016
- 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 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Risk Factors for Patients With Peri-implant Disease： A Prospective Study
- ClinicalTrials.gov ID
- NCT02676661
- Acronym / sponsor ID
- Jhchen
- Conditions
- Jaw, Edentulous, Partially
- Keywords
- peri-implant disease, risk factors, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Feb 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.
To investigate the prevalence and risk factors for peri-implant disease in partially edentulous patients rehabilitated with implants supported crown or bridge so as to provide evidence for clinical prevention and control.
Detailed description
The aim of the present study is to identify the prevalence of peri-implant disease in partially edentulous subjects treated with osseointegrated implants, using clinical parameters, as well as to analyse the possible disease association with demographic, behavioural, and biological risk variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no peri-implant disease | – | –The subjects who did not suffer from peri-implant disease. |
| peri-implant disease | – | –The subjects who suffered from peri-implant disease. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Partially edentulous patients implant dental implants and will be restored with implant-supported fixed partial dentures and single crowns at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University
Key inclusion criteria (1 listed)
- Partially edentulous patients will implant at least one implant and will be restored with implant-supported fixed partial dentures and single crowns.
Key exclusion criteria (3 listed)
- Jaw radiotherapy treatment before and after implanting. Patients who have bruxism,xerostomia or the adjacent teeth periapical periodontitis.
- Patients who suffered with oral mucosa disease,or aggressive periodontitis or jaw defect.
- Patients who suffered with mental and psychological disease will influence their oral health normal maintenance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
peri-implant disease
Time frame: at the 5 years after prosthetic loading.
Peri-implant disease includes Peri-implant mucositis and Peri-implantitis.Peri-implant mucositis: BoP/suppuration but no detectable bone loss. Peri-implantitis: BoP/suppuration and bone loss >2 mm.
3 secondary outcomes
Gingival Bleeding on Probing
Time frame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Pocket depths
Time frame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Marginal bone loss
Time frame: at the first day,6 months 1,3 and 5 years after prosthetic loading.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- 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.
Yongjin Chen, PhD 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 Jaw, Edentulous, Partially, run by Air Force Military Medical University, China 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 1 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 8 Feb 2016. 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 Jihua Chen, PhD (029-84776329, jhchen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri-implant disease (time frame: at the 5 years after prosthetic loading.). 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 8 Feb 2016.