Periodontal Disease Clinical Trial
Official title:
Biomarkers of Periodontal Disease Progression
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.
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. ;
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