PeriodontitisNCT01742728
Nagasaki and Tokushima
An observational study of Periodontitis, run by University of Tokushima at 1 site in Japan.
Trial summary
we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers, cytokines, and periodontitis through community-based study held in the Goto city, Japan. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- How many people
- 2,000 participants
- Where
- 1 siteJapan
- Study dates
- May 2009to Mar 2015
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: community sample
Who may be able to join
- more than 15 teeth
Who cannot join
- less than 15 teeth
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
University of Nagasaki
Nagasaki, Goto
Toshiyuki Saito, +81-(95)-819-7662
About this study
Official title: Oxidative Stress in Community-dwelling Adults
we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers, cytokines, and periodontitis through community-based study held in the Goto city, Japan.
- Conditions
- Periodontitis
- Keywords
- oxidative stress, antioxidant, periodontitis, serum immunoglobulin G, antibody titer
- Medical subject headings
- Periodontitis
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 |
|---|---|---|
| Nagasaki | Sample collection | |
| Tokushima | Oxidative stress, cytokine | |
| Kanagawa | oxidative stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress and periodontitis
reactive oxygen metabolites were measured. immunoglobulin G antibodies were measured by enzyme-linked immunosorbent assay.
Measured: participants will be followed by an expected 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 posted5 Dec 2012 (estimated)
- Study startMay 2009
- Primary completionMar 2012
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tokushima
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naofumi Tamaki, University of Tokushima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742728
- Sponsor's protocol ID
- goto2012
- Status last verified
- Dec 2012
- First submitted
- 28 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
Publications
Hayashida H, Kawasaki K, Yoshimura A, Kitamura M, Furugen R, Nakazato M, Takamura N, Hara Y, Maeda T, Saito T. Relationship between periodontal status and HbA1c in nondiabetics. J Public Health Dent. 2009 Summer;69(3):204-6. doi: 10.1111/j.1752-7325.2009.00122.x.
PubMed 19486462Tamaki N, Yoshino F, Fukui M, Hayashida H, Yoshida A, Kitamura M, Iwasaki T, Furugen R, Kawasaki K, Nakazato M, Maeda T, Kokeguchi S, Yamamoto T, Lee MC, Ito HO, Saito T. Relationship among salivary antioxidant activity, cytokines, and periodontitis: the Nagasaki Island study. J Clin Periodontol. 2015 Aug;42(8):711-718. doi: 10.1111/jcpe.12438. Epub 2015 Aug 29.
PubMed 26227009
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress in Community-dwelling Adults
- ClinicalTrials.gov ID
- NCT01742728
- Acronym / sponsor ID
- goto2012
- Conditions
- Periodontitis
- Keywords
- oxidative stress, antioxidant, periodontitis, serum immunoglobulin G, antibody titer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of TokushimaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 5 Dec 2012 (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.
we analyzed the relationship between oxidative stress, immunoglobulin G antibody titers, cytokines, and periodontitis through community-based study held in the Goto city, Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nagasaki | – | –Sample collection |
| Tokushima | – | –Oxidative stress, cytokine |
| Kanagawa | – | –oxidative stress |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- more than 15 teeth
Key exclusion criteria (1 listed)
- less than 15 teeth
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
oxidative stress and periodontitis
Time frame: participants will be followed by an expected average of 1 year.
reactive oxygen metabolites were measured. immunoglobulin G antibodies were measured by enzyme-linked immunosorbent assay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Background: PubMed 19486462Hayashida H, Kawasaki K, Yoshimura A, Kitamura M, Furugen R, Nakazato M, Takamura N, Hara Y, Maeda T, Saito T. Relationship between periodontal status and HbA1c in nondiabetics. J Public Health Dent. 2009 Summer;69(3):204-6. doi: 10.1111/j.1752-7325.2009.00122.x.
- Derived from this study: PubMed 26227009Tamaki N, Yoshino F, Fukui M, Hayashida H, Yoshida A, Kitamura M, Iwasaki T, Furugen R, Kawasaki K, Nakazato M, Maeda T, Kokeguchi S, Yamamoto T, Lee MC, Ito HO, Saito T. Relationship among salivary antioxidant activity, cytokines, and periodontitis: the Nagasaki Island study. J Clin Periodontol. 2015 Aug;42(8):711-718. doi: 10.1111/jcpe.12438. Epub 2015 Aug 29.
- JapaneseLink provided by the sponsor.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
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 University of Tokushima 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: status not confirmed, as of the sponsor's last update on 5 Dec 2012. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxidative stress and periodontitis (time frame: participants will be followed by an expected average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01742728, which also lists 2 linked publications.
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 5 Dec 2012.