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Biomarkers of Periodontal Disease Progression

NCT01489839 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2018-02-07

No results posted yet for this study

Summary

The primary purpose of the study will be to look for biological biomarkers to determine which people with gum disease will have a worsening of the disease. A second objective of this study will be to look at the effects of periodontal treatment on the levels of the biomarkers that are identified.

Conditions

  • Periodontal Disease

Interventions

OTHER

Periodontal therapy

All subjects will have professional dental prophylaxis and periodontal therapy withheld for 12 months during the disease progression and monitoring phase. After 12 months, subjects with periodontal disease will receive periodontal therapy to consist of scaling and root planing, and periodontally healthy subjects will receive professional dental prophylaxis. Subjects with periodontal disease will also receive Supportive Periodontal Therapy at the 3- and 6-month post-therapy visits. Subjects showing periodontal disease progression greater than a predetermined threshold during the monitoring or maintenance phases of the study will be given rescue therapy consisting of placement of a local antibiotic at the site of disease progression.

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • NYU Langone Health

    collaborator OTHER

  • State University of New York at Buffalo

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Southern Illinois University

    collaborator OTHER

  • The Forsyth Institute

    lead OTHER

Principal Investigators

  • Ricardo P Teles, DDS, DMSc · The Forsyth Institute

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-06-30
Completion
2017-05-31

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489839 on ClinicalTrials.gov