NCT01658475

Brief Summary

This study was performed to evaluate prospectively the diagnostic utility of a blood IgG antibody titer test against periodontal pathogens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

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

January 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

July 31, 2012

Last Update Submit

August 2, 2012

Conditions

Keywords

IgG titerperiodontopathic bacteria

Outcome Measures

Primary Outcomes (1)

  • Level of IgG antibodies in serum/plasma against periodontal pathogens

    Serum/plasma samples will be screened for the presence of IgG antibodies against the below mentioned periodontal pathogens, using the "ELISA" method. Aggregatibacter actinomycetemcomitans, Eikenella corrodens, Prevotella intermedius, Porphyromonas gingivalis

    1 to 3 months after basic periodontal treatment (Scaling and root planing)

Secondary Outcomes (3)

  • Periodontal pocket depth

    1 to 3 months after basic periodontal treatment

  • Bleeding on probing

    1 to 3 monthsafter basic periodontal treatment

  • Tooth mobility

    1 to 3 months after basic periodontal treatment

Study Arms (1)

periodontitis

those with periodontitis and those without periodontitis

Eligibility Criteria

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

Patients who visit university hospitals to receive periodontal treatment are patients group. Employees who receive occupational health check at a company facility.

You may qualify if:

  • periodontal patients
  • adults

You may not qualify if:

  • difficulty of communication
  • received periodontal therapy within 3 months
  • with other diseases, i.e., hypertension, diabetes (self reported)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Aichi Gakuin University, School of Dentistry

Nagoya, Aichi-ken, 4648650, Japan

Location

Toyota Motor Corporation

Toyota, Aichi-ken, 4442225, Japan

Location

Nihon University School of Dentistry at Matsudo

Matsudo, Chiba, 2718587, Japan

Location

Hiroshima University Graduate School of Biomedical Sciences

Hiroshima, Hiroshima, 7348553, Japan

Location

Tohoku University Graduate School of Dentistry

Sendai, Miyagi, 9808575, Japan

Location

Nagasaki University Graduate School of Biomedical Sciences

Nagasaki, Nagasaki, 8528588, Japan

Location

Niigata University Faculty of Dentistry

Niigata, Niigata, 9518514, Japan

Location

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Okayama, Okayama-ken, 7008525, Japan

Location

Osaka University Graduate School of Dentistry

Suita, Osaka, 5650871, Japan

Location

The University of Tokushima Graduate School, Institute of Health Biosciences

Tokushima, Tokushima, 7708504, Japan

Location

Tokyo Medical and Dental University Graduate School

Bunkyo-ku, Tokyo, 1138510, Japan

Location

Nippon Dental University, School of Life Dentistry at Tokyo

Chiyoda-ku, Tokyo, 1020071, Japan

Location

Related Publications (1)

  • Kudo C, Naruishi K, Maeda H, Abiko Y, Hino T, Iwata M, Mitsuhashi C, Murakami S, Nagasawa T, Nagata T, Yoneda S, Nomura Y, Noguchi T, Numabe Y, Ogata Y, Sato T, Shimauchi H, Yamazaki K, Yoshimura A, Takashiba S. Assessment of the plasma/serum IgG test to screen for periodontitis. J Dent Res. 2012 Dec;91(12):1190-5. doi: 10.1177/0022034512461796. Epub 2012 Sep 26.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and/or serum

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Shogo Takashiba, Professor

    Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Pathiphysiology - Periodontal Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 7, 2012

Study Start

January 1, 2007

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations