Periodontal therapy does not improve cardiovascular disease biomarkers: a randomized clinical trial

This randomized clinical trial is currently under the process of submission to a peer-review scientific journal. Contents available in this Fileset (published via Figshare): Tables, figures, and anonymized patient-level raw data. Abstract is also available below. Related publications: 1. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. (2011) Ramírez, Arce, Contreras. Trials URL (open access): http://www.trialsjournal.com/content/12/1/46 2. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study (2014). Ramírez, Parra, Gutierrez et al. Australian dental journal. URL (open access): http://figshare.com/articles/Biomarkers_of_cardiovascular_disease_are_increased_in_untreated_chronic_periodontitis_a_case_control_study_/1096115 --------------------------------------------------------------------- <strong>Abstract</strong> Introduction The purpose of this interventional study (parallel, single blind, randomized controlled trial) was to assess the effect of periodontal therapy on biomarkers of cardiovascular disease in patients with chronic periodontitis. Materials and methods Subjects with chronic moderate to severe periodontitis were invited to participate in the study. Patients were randomized (stratified by gender/smoking status) to periodontal intervention therapy using the full mouth disinfection protocol (one-stage supragingival/subgingival plaque cleaning plus chlorhexidine 1%) or adult dental prophylaxis (supragingival plaque removal). Participants were monitored at baseline, 24 hours and 12 weeks after the assigned intervention. The primary outcome was the change of brachial artery endothelium-dependent flow mediated dilatation at 12-weeks post-therapy. Secondary outcomes included biochemical cardiovascular disease biomarkers (C-reactive protein, E-selectin, MPO, ICAM-1, VCAM-1, MMP-9, tPAI-1), lipid profile and white-cell count. Probing depth, clinical attachment loss, number of periodontal pockets and subgingival microbiota (determined by microbial culture and polymerase chain reaction) were used to diagnose disease severity and to evaluate the effectiveness of periodontal therapy. Results Patients were randomized to dental prophylaxis (n=55) and periodontal intervention therapy (n=47). At 12 weeks of follow-up, forty-seven patients in the dental prophylaxis group and forty-one patients in the periodontal intervention therapy completed the study. Full mouth disinfection compared to dental prophylaxis group did not result in significant changes on endothelial dependent flow-mediated dilatation and cardiovascular disease biomarkers at 12 weeks post-treatment. Even though clinical periodontal and microbiological parameters were improved. Conclusions Non-surgical periodontal treatment of moderate to severe chronic periodontitis with the full mouth disinfection protocol did not improve endothelial function and other inflammatory biomarkers of cardiovascular disease. ClinicalTrials.gov Identifier: NCT00681564