NCT01742728

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

2.8 years

First QC Date

November 28, 2012

Last Update Submit

December 3, 2012

Conditions

Periodontitis

Keywords

oxidative stress, antioxidant, periodontitis, serum immunoglobulin Gantibody titer

Outcome Measures

Primary Outcomes (1)

  • oxidative stress and periodontitis

    reactive oxygen metabolites were measured. immunoglobulin G antibodies were measured by enzyme-linked immunosorbent assay.

    participants will be followed by an expected average of 1 year.

Study Arms (3)

Nagasaki

Sample collection

Tokushima

Oxidative stress, cytokine

Kanagawa

oxidative stress

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • more than 15 teeth

You may not qualify if:

  • less than 15 teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nagasaki

Nagasaki, Goto, Japan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 19486462BACKGROUND

  • Tamaki 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.

    PMID: 26227009DERIVED

Related Links

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oxidative stress and periodontitis

Study Record Dates

First Submitted

November 28, 2012

First Posted

December 5, 2012

Study Start

May 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2015

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

JP(1)