NCT00569075

Brief Summary

The goal of this study is to facilitate early diagnosis of gum disease. Proteins associated with cell death will be isolated from gum pockets of diseased and healthy patients and evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

December 5, 2007

Last Update Submit

May 9, 2017

Conditions

Periodontitis

Keywords

Apoptic biomarkersEarly detection periodontitisGingival crevicular fluidHealthy subjects

Study Arms (2)

High Risk

High risk disease prone population

Other: collection of gingival crevicular fluid

Low Risk

Low risk disease population

Other: collection of gingival crevicular fluid

Interventions

collection of gingival crevicular fluidOTHER

GCF samples will be collected at 3 month intervals

High RiskLow Risk

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

healthy adults with healthy gums or those with periodontitis

You may qualify if:

  • Adults over age of 18
  • Healthy or diagnosis of periodontitis

You may not qualify if:

  • Active treatment with anti-inflammatory agents such as NSAIDs or steroids and pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michigan Center for Oral Health Research

Ann Arbor, Michigan, 48106, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva and plaque

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Yvonne Kapila, DDS, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

October 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

US(1)