Evaluating the impact of oral hygiene instruction and digital oral health education within cardiac rehabilitation clinics: A protocol for a novel, dual centre, parallel randomised controlled trial

Diseases of the periodontal tissues including gingivitis and periodontitis can affect up to 90% and 50% of the population respectively. These conditions are multifactorial inflammatory conditions involving a dysbiotic biofilm that, if left untreated, can lead to the destruction of the supporting structures of the teeth and have significant systemic implications, specifically on cardiovascular health. The elevation of inflammatory markers, particularly high-sensitive C-reactive protein (hsCRP), are strongly associated with an increased risk of atherosclerosis, a key risk factor for cardiovascular disease (CVD). HsCRP as well as other inflammatory markers can be detected in blood samples as early as 21 days after ceasing toothbrushing, due to the immune response to stagnant oral biofilm. The most effective way to ensure oral biofilm cannot remain on oral tissues, thus preventing periodontitis and reducing inflammatory CVD risk, is with good oral hygiene. The primary aim of this study is to assess whether individualised oral hygiene instruction (OHI) partnered with a digital oral health education (DOHE) package can improve the oral health of patients living with CVD. A total of 165 participants will be recruited from the Westmead and Blacktown Mt Druitt cardiac rehabilitation out-patient clinics into this dual centre, single blind, parallel design, randomised controlled trial. A baseline oral health clinical examination will be completed, followed by a self-report questionnaire before they are randomised in a 1:1:1 ratio into one of 3 arms as follows: individualised OHI partnered with DOHE (Group A), (Group B) DOHE only (Group B), and control/usual care (no oral health education) (Group C). Groups will have their intervention repeated at the 6-week follow-up. After completing the 12-week follow-up, Group B and Group C will receive tailored OHI. Group C will also receive the DOHE package. The primary outcome is the change in approximal plaque index score between baseline and 6-week follow up. The study has been approved by the Western Sydney Local Health District Human Ethics Committee 2023/ETH00516. Results will be published in peer-reviewed journals and presented at conferences. ACTRN12623000449639p ANZCTR: https://www.anzctr.org.au/.