PeriodontitisNCT02417363
Study on the Relationship Between Periodontitis and Renal Disease
An observational study of Periodontitis, run by Zhejiang University at 1 site in China.
Trial summary
Analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2016
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 50 individuals are recruited for each group, the factors of age and gender are matched while selecting the incruited indiduals,all participants were in general good health(except renal disease) and non-smoking.
Who may be able to join
- all participants were in general good health(except renal disease) and non-smoking
Who cannot join
- less than 20 teeth in the dentin
- hypertension
- the presence of systemic disease (e.g., diabetes mellitus ,coronary heart disease, liver, or lung disease)
- a history or the symptom of any other acute or chronic infections
- systemic antibiotic treatment within previous 4 weeks
- periodontal treatment within1 month
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006
Na Zhou, 86-571-87217437, kate0228@163.com
Na Zhou
About this study
Official title: Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
Analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease.
Read the detailed description
A total of 200 population is recruited, individuals are divided into four groups according to a periodontal examination and a general physical examination: healthy individuals ,periodontitis, renal disease patients with healthy periodontium, and renal disease patients wth peridontitis. Fasting blood samples and gingival crevicular fluid are collected from all individuals, and inflammatory markers are analysed for the four groups.
- Conditions
- Periodontitis
- Keywords
- biomarkers, renal disease, periodontitis
- Medical subject headings
- Periodontitis, Kidney Diseases
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 |
|---|---|---|
| Group A | the control group,healthy individuals | |
| Group B | patients with 1-4 stage K/DOQI (Kidney Disease Outcome Quality Initiative) chronic kidney disease, but healthy periodontium | |
| Group C | patients with periodontitis, but healthy renal conditions | |
| Group D | patients with 1-4 stage K/DOQI (Kidney Disease Outcome Quality Initiative) chronic kidney disease and periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers analysis of the four groups
Analysis of inflammatory biomarkers of blood and gingival crevicular fluid samples of the four groups
Measured: 3 months after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Zhou, Zhejiang University
- Investigators
- Hui Chen, Study director, Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417363
- Sponsor's protocol ID
- ZJUSH2015-1
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2015
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
- ClinicalTrials.gov ID
- NCT02417363
- Acronym / sponsor ID
- ZJUSH2015-1
- Conditions
- Periodontitis
- Keywords
- biomarkers, renal disease, periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 15 Apr 2015 (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.
Analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease.
Detailed description
A total of 200 population is recruited, individuals are divided into four groups according to a periodontal examination and a general physical examination: healthy individuals ,periodontitis, renal disease patients with healthy periodontium, and renal disease patients wth peridontitis. Fasting blood samples and gingival crevicular fluid are collected from all individuals, and inflammatory markers are analysed for the four groups.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –the control group,healthy individuals |
| Group B | – | –patients with 1-4 stage K/DOQI (Kidney Disease Outcome Quality Initiative) chronic kidney disease, but healthy periodontium |
| Group C | – | –patients with periodontitis, but healthy renal conditions |
| Group D | – | –patients with 1-4 stage K/DOQI (Kidney Disease Outcome Quality Initiative) chronic kidney disease and periodontitis |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50 individuals are recruited for each group, the factors of age and gender are matched while selecting the incruited indiduals,all participants were in general good health(except renal disease) and non-smoking.
Key inclusion criteria (1 listed)
- all participants were in general good health(except renal disease) and non-smoking
Key exclusion criteria (6 listed)
- less than 20 teeth in the dentin
- hypertension
- the presence of systemic disease (e.g., diabetes mellitus ,coronary heart disease, liver, or lung disease)
- a history or the symptom of any other acute or chronic infections
- systemic antibiotic treatment within previous 4 weeks
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
Inflammatory markers analysis of the four groups
Time frame: 3 months after sampling
Analysis of inflammatory biomarkers of blood and gingival crevicular fluid samples of the four groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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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.
Hui Chen study director
Affiliated Hospital of Stomatology, School of Medicine, Zhejiang University
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 Periodontitis, run by Zhejiang University 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 6 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 17 Apr 2015. 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 Na Zhou (86-571-87217437, kate0228@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers analysis of the four groups (time frame: 3 months after sampling). 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 17 Apr 2015.