Periodontal DiseaseNCT00553007
The Relation Between Periodontal Disease and Metabolic Syndrome
A study testing Periodontal therapy in people with Periodontal Disease and Metabolic Syndrome, run by Aichi Gakuin University at 1 site in Japan.
Trial summary
Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontal Disease, Metabolic Syndrome
- What is being tested?
- Periodontal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Oct 2009
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with periodontal disease
Who cannot join
- Patients with malignant disease
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Aichi Gakuin University
Nagoya, Aichi-ken, 464-8651
About this study
Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.
- Conditions
- Periodontal Disease, Metabolic Syndrome
- Being tested
- Periodontal therapy
- Keywords
- Periodontal disease, Metabolic Syndrome
- Medical subject headings
- Periodontal Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal therapyProcedure or surgery
Normal periodontal therapy is performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
features of periodontal disease and metabolic syndrome
Measured: one year
Secondary outcomes (1)
Pulse wave velocity; max Intima-Media Thickness(IMT); mean IMT; ankle-brachial blood pressure index; toe-brachial blood pressure index
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startOct 2007
- Study completionOct 2009 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aichi Gakuin University
- Sponsor type
- University, hospital or other
- Investigators
- Tatsuaki Matsubara, MD. PhD, Principal investigator, Aichi Gakuin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553007
- Sponsor's protocol ID
- AGU070001
- Status last verified
- Oct 2007
- First submitted
- 1 Nov 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Periodontal Disease and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00553007
- Acronym / sponsor ID
- AGU070001
- Conditions
- Periodontal Disease, Metabolic Syndrome
- Keywords
- Periodontal disease, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aichi Gakuin UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Oct 2009 (estimated)
- First posted
- 2 Nov 2007 (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.
Periodontal disease is associated with the components of Metabolic syndrome, such as obesity, diabetes, hypertension and hyperlipidemia. Therefore, strong relation with periodontal disease and metabolic syndrome is suggested. the overall goal of this study is to define the relation between periodontal disease and metabolic syndrome, including atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with periodontal disease
Key exclusion criteria (2 listed)
- Patients with malignant disease
- Pregnant women
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 therapyNormal periodontal therapy is performed. | Procedure or surgery | – |
Primary outcome
features of periodontal disease and metabolic syndrome
Time frame: one year
1 secondary outcome
Pulse wave velocity; max Intima-Media Thickness(IMT); mean IMT; ankle-brachial blood pressure index; toe-brachial blood pressure index
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
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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.
Tatsuaki Matsubara, MD. PhD principal investigator
Aichi Gakuin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodontal therapy in people with Periodontal Disease and Metabolic Syndrome, run by Aichi Gakuin 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 2 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 2 Nov 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatsuaki Matsubara, MD, PhD (+81-52-759-2111, matt@dpc.agu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
features of periodontal disease and metabolic syndrome (time frame: one 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 2 Nov 2007.