Targeting the reduction of inflammatory risk associated with cardiovascular disease by treating periodontitis either alone or in combination with a systemic anti-inflammatory agent: protocol for a pilot, parallel group, randomised controlled trial

INTRODUCTION: Cardiovascular disease (CVD) is associated with systemic inflammation. Colchicine, an anti-inflammatory drug, reduces the incidence of CVD events. Periodontitis, a chronic localised inflammatory disease of the tissues supporting the teeth, triggers systemic inflammation and contributes to inflammatory risk. Treatment for periodontitis reduces markers of inflammation, however, there is no evidence on whether an anti-inflammatory medication in combination with periodontal treatment can reduce the inflammatory risk. The aim of this trial is to investigate the effect of periodontal treatment either alone or in combination with an anti-inflammatory agent on inflammation in patients with periodontitis and CVD at 8 weeks. METHODS AND ANALYSIS: 60 participants with moderate-to-severe periodontitis, coronary artery disease and an increased inflammatory risk (>2 mg/L high sensitivity C reactive protein (hsCRP) levels) will be recruited from a tertiary referral hospital in Australia in a parallel design, single blind, randomised controlled trial. Baseline hsCRP levels, lipid profile and periodontal assessment will be completed for each participant before they are randomised in a 1:1:1:1 ratio to one of 4 arms as follows: (group A) periodontal treatment and colchicine; (group B) periodontal treatment only; (group C) colchicine only or (group D) control/delayed periodontal treatment. Periodontal treatment will be provided over three treatment visits, 0.5 mg of colchicine will be provided as a daily tablet. Participants will be followed up at 8 weeks to measure primary and secondary outcomes and complete a follow-up questionnaire. The primary outcome is the difference in hsCRP levels, the secondary outcomes are differences in lipid levels and periodontal parameters and the feasibility measures of recruitment conversion rate, completion rate and the safety and tolerability of the trial. ETHICS AND DISSEMINATION: The study has been approved by the Western Sydney Local Health District Human Ethics Committee (protocol number 2019/ETH00200). Results will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: ACTRN12619001573145.