Smoking is a significant risk factor for periodontitis and cardiovascular disease (CVD). Systemic sub-antimicrobial dose doxycycline (SDD, Periostat®) improves the clinical outcomes of scaling and root planing (SRP) in patients with periodontitis and reduces the levels of high sensitivity C-reactive protein (hsCRP) in subjects with CVD. Objectives: The purpose of the ongoing randomized clinical study is to characterize the pattern of levels of selected biomarkers of systemic inflammation correlated with risk of CVD in smokers with periodontitis. The study may also determine whether dimunition in the levels of these markers can be achieved with SRP alone and/or with adjunctive SDD thereby lowering the risk for CVD. Methods: 30 patients are enrolled in a 15 month study; 9 months of SDD or placebo administration with a 6 month washout. All subjects receive periodontal therapy every 3 months, at which time plasma, serum, oral mouth rinse, saliva and gingival crevicular fluid (GCF) volumes and samples are obtained and clinical measurements are recorded. Currrently 138 plasma samples collected at baseline and at 3 month intervals have been analyzed for levels of cotinine and inflammatory biomarkers by ELISA. Results: Stratification of the samples into quartiles with respect to cotinine levels reveals that the strongest correlations to GCF volume, sICAM and IL-8 are within the quartile of samples with the highest cotinine values, whereas other biomarkers such as IL-1&beta,IL-6, TNF-&alpha and hsCRP are not closely correlated with cotinine. Conclusions: Preliminary data suggests that therapy with SRP alone and/or with adjunctive SDD may lead to a disassociation of cotinine to a number of biomarkers of systemic inflammation including hsCRP which may be maximized by the modulation of the host reponse with SDD. Additional conclusions await breaking of the blind and subsequent clinical and assay analyses. Supported by Philip Morris External Research Program, CollaGenex Pharmaceuticals, NIH-GCRC-Center M01RR10710.

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