Periodontal DiseaseRAPA-JMCSNCT01866761
Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services
An observational study of Periodontal Disease and Atherosclerosis, run by Okayama University at 1 site in Japan.
Trial summary
Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontal Disease, Atherosclerosis
- What is being tested?
- Periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2008to Jan 2012
- How long will I take part?
- 2 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This clinical study was performed by the local clinics which belonged to Tokyo Medical Practitioners Association, Tokyo Dental Practitioners Association, and Chiba Medical Practitioners Association. 37 patients (with lifestyle-related diseases under consultation in either of 16 medical clinics), and 79 periodontal patients (not undergoing treatment at a medical clinic,) were enrolled. The subjects constituted a broad cross-section of the local society. Medical treatment at an internal medicine clinic and clinical periodontal treatment including periodontal surgery at a dental clinic were performed on all the subjects. Twenty-six patients dropped out of the study and medical treatment and periodontal treatment were provided to the remaining 90 subjects (mean ages: 59.2 ± 12.3 yrs).
Who may be able to join
- Periodontal disease: inflamed gingiva with positive for bleeding on probing or teeth with probing pocket depth more than 4 mm Lifestyle-related disease: Plaques are included when maximum IMT is measured. Furthermore, hypertension was defined as systolic blood pressure of more than 140 mm Hg or diastolic pressure of more than 90 mm Hg, or both, or patients already being treated by anti-hypertensive agents. Hypercholesterolemia was defined by serum concentration of LDL-C of more than 140 mg/dL, or patients already being treated by lipid-lowering agents. Diabetes mellitus was defined by HbA1c of more than 6.9 % (NGSP value) or fasting blood sugar of more than 126 mg/dl or both, or patients already being treated by agents for diabetes.
Who cannot join
- At initial consultation and examination (Baseline), patients with less than 6 months after the onset of acute myocardial infarction (AMI), and with a past history or complication of serious heart disease were excluded. Similarly, those with less than 6 months after cardiovascular revascularization surgery, less than 6 months after the onset of cerebrovascular disorder, or serious liver disease or renal disease were also excluded.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Okayama University of Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Okayama, Okayama-ken, 700-8525
About this study
Official title: Analysis of the Relationship Between Periodontal Disease and Atherosclerosis Within a Local Cooperation System of Japanese Medical Services
Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services.
Materials and methods:
- A prospective multi-center case cohort study was conducted on 37 ambulatory medical patients (with lifestyle-related diseases under consultation in either of the medical clinics registered as collaborative investigation facilities) and 79 periodontal patients (who were seen by the dental clinics registered as collaborative investigation facilities).
- Medical treatment and clinical periodontal treatment were provided on the subjects under medical and dental care across borders by each internal medicine and dental clinics.
- Systemic examination of lifestyle-related disease and periodontal examination were performed before and after periodontal treatment, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed before and after periodontal treatment.
- Conditions
- Periodontal Disease, Atherosclerosis
- Being tested
- Periodontal treatment
- Medical subject headings
- Periodontal Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis, Lifestyle-related disease | Not described Receives: Procedure: Periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between probing pocket depth and anti-periodontopathic bacteria IgG antibody titer for periodontitis and the MAX intima-media thickness, urea sugar, urea protein, urea occult blood, creatinine, and eGFR for atherosclerosis
At following 3-time points; Baseline, After initial preparation of periodontal treatment, Starting point of supportive periodontal therapy
Measured: an expected average of 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startNov 2008
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- 116 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Okayama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shogo Takashiba, DDS, PhD, Professor of Periodontal Science, Okayama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866761
- Sponsor's protocol ID
- TCHK_OU-RN605
- Acronym
- RAPA-JMCS
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Relationship Between Periodontal Disease and Atherosclerosis Within a Local Cooperation System of Japanese Medical Services
- ClinicalTrials.gov ID
- NCT01866761
- Acronym / sponsor ID
- RAPA-JMCS / TCHK_OU-RN605
- Conditions
- Periodontal Disease, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Okayama UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jan 2012 (actual)
- First posted
- 31 May 2013 (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.
Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services.
Materials and methods:
- A prospective multi-center case cohort study was conducted on 37 ambulatory medical patients (with lifestyle-related diseases under consultation in either of the medical clinics registered as collaborative investigation facilities) and 79 periodontal patients (who were seen by the dental clinics registered as collaborative investigation facilities).
- Medical treatment and clinical periodontal treatment were provided on the subjects under medical and dental care across borders by each internal medicine and dental clinics.
- Systemic examination of lifestyle-related disease and periodontal examination were performed before and after periodontal treatment, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed before and after periodontal treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontitis, Lifestyle-related disease | – | Procedure: Periodontal treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This clinical study was performed by the local clinics which belonged to Tokyo Medical Practitioners Association, Tokyo Dental Practitioners Association, and Chiba Medical Practitioners Association. 37 patients (with lifestyle-related diseases under consultation in either of 16 medical clinics), and 79 periodontal patients (not undergoing treatment at a medical clinic,) were enrolled. The subjects constituted a broad cross-section of the local society. Medical treatment at an internal medicine clinic and clinical periodontal treatment including periodontal surgery at a dental clinic were performed on all the subjects. Twenty-six patients dropped out of the study and medical treatment and periodontal treatment were provided to the remaining 90 subjects (mean ages: 59.2 ± 12.3 yrs).
Key inclusion criteria (1 listed)
- Periodontal disease: inflamed gingiva with positive for bleeding on probing or teeth with probing pocket depth more than 4 mm Lifestyle-related disease: Plaques are included when maximum IMT is measured. Furthermore, hypertension was defined as systolic blood pressure of more than 140 mm Hg or diastolic pressure of more than 90 mm Hg, or both, or patients already being treated by anti-hypertensive agents. Hypercholesterolemia was defined by serum concentration of LDL-C of more than 140 mg/dL, or patients already being treated by lipid-lowering agents. Diabetes mellitus was defined by HbA1c of more than 6.9 % (NGSP value) or fasting blood sugar of more than 126 mg/dl or both, or patients already being treated by agents for diabetes.
Key exclusion criteria (1 listed)
- At initial consultation and examination (Baseline), patients with less than 6 months after the onset of acute myocardial infarction (AMI), and with a past history or complication of serious heart disease were excluded. Similarly, those with less than 6 months after cardiovascular revascularization surgery, less than 6 months after the onset of cerebrovascular disorder, or serious liver disease or renal disease were also excluded.
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 |
|---|---|---|
| Periodontal treatment | Procedure or surgery | Periodontitis, Lifestyle-related disease |
Primary outcome
Relation between probing pocket depth and anti-periodontopathic bacteria IgG antibody titer for periodontitis and the MAX intima-media thickness, urea sugar, urea protein, urea occult blood, creatinine, and eGFR for atherosclerosis
Time frame: an expected average of 1.5 year
At following 3-time points; Baseline, After initial preparation of periodontal treatment, Starting point of supportive periodontal therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontal Disease and Atherosclerosis, run by Okayama University at 1 site in Japan.
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 1 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: finished, as of the sponsor's last update on 31 May 2013. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between probing pocket depth and anti-periodontopathic bacteria IgG antibody titer for periodontitis and the MAX intima-media thickness, urea sugar, urea protein, urea occult blood, creatinine, and eGFR for atherosclerosis (time frame: an expected average of 1.5 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 31 May 2013.