Clinical Trial: Biomarkers of Periodontal Disease Progression

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Biomarkers of Periodontal Disease Progression

Brief 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.

Detailed Summary: This multicenter clinical study will investigate biomarkers of periodontal disease progression. The study will enroll 375 subjects with periodontal disease and 125 periodontally healthy subjects. All subjects will be monitored clinically and have samples taken every 2 months for 12 months for analysis of inflammatory and immunological biomarkers and microbial species. Subjects displaying periodontal disease progression greater than an established threshold will receive periodontal rescue therapy at progressing periodontal sites and continue with monitoring. Periodontally healthy subjects and non-progressing sites in subjects with periodontal disease will serve as controls. After 12 months, subjects with periodontal disease will receive periodontal therapy consisting of 4 quadrants of scaling and root planing. Periodontally healthy subjects will receive prophylaxis and scaling and exit the study. Following periodontal therapy, subjects with periodontal disease will be followed for a maintenance period of 6 months for clinical and biological monitoring. Statistical analyses will compare biomarkers and microbial species between periodontally healthy subjects and subjects with periodontal disease, between progressing and non-progressing periodontally diseased sites, and between periodontally diseased sites before and after periodontal therapy.
Sponsor: The Forsyth Institute

Current Primary Outcome: Change in Clinical Attachment Level (CAL) [ Time Frame: After the baseline visit, subjects will return to the clinic every 2 months (± 7 days relative to baseline) for 12 months. ]

The primary study outcome will be progression of periodontal disease as determined by CAL. Initial disease progression at a site will be defined as loss of ≥2 mm in CAL at any assessment or follow-up visit compared with baseline. Subsequent disease progression will be similarly defined except that the loss in CAL will be compared with the last visit at which disease progression was detected.


Original Primary Outcome: Same as current

Current Secondary Outcome: Biomarker Levels compared between progressing and non-progressing sites as determined by CAL changes [ Time Frame: Levels measured every 2 months for 12 months ]

Biomarker levels will be compared between progressing and non-progressing periodontally diseased sites. The biomarkers include microbial species in saliva, GCF, and plaque and inflammatory and immunological markers in serum, saliva, and GCF. In addition, differences will be compared between diseased subjects before and after periodontal therapy and between periodontally diseased and healthy subjects.


Original Secondary Outcome: Same as current

Information By: The Forsyth Institute

Dates:
Date Received: December 6, 2011
Date Started: January 2012
Date Completion: May 2017
Last Updated: June 16, 2016
Last Verified: June 2016