Design This is a parallel-group, unicentric, randomised, assessor-blinded, superiority trial with equal allocation ratio to evaluate and compare the effects of periodontal treatment on endothelial function, measured by a flow-mediated dilation of brachial artery, in patients with a recent ST-segment elevation myocardial infarction (STEMI).Study population The study population included a total of 48 patients who were recruited from a hospital in Brazil. Patients who had a recent episode of acute STEMI and also exhibited severe periodontal disease were included, while exclusion criteria included factors like patients who were <30 years old, HIV-positive, had chronic inflammatory or neoplastic diseases, pregnant, significant dental loss (<8 teeth remaining) etc. After seeking consent, patients were randomised to two groups: patients in the intervention group were provided with periodontal treatment while no treatment was given to patients in the control group. Patients were assessed for the primary outcome (flow-mediated dilation [FMD] in the brachial artery), secondary outcomes (periodontal health and inflammatory markers) and other safety outcomes after six months of intervention.Data analysis Data was analysed using the intention-to-treat principle, wherein t-tests and chi-square tests were used to compare baseline variables between groups, while dependent t-test was used for within-group comparisons. The Mann-Whitney test was used to compare cytokine levels from baseline to six-month follow-up. Effect sizes were presented along with their respective p values and confidence intervals. Lastly, a sensitivity analysis was also carried out by taking stringent p values for establishing significance (p = 0.025).Results Statistically significant improvement was seen in FMD values among patients who received periodontal treatment (from 9.0 +/- 4.4% at baseline to 12.1 +/- 5.6% at follow-up; p = 0.01), while the patients in the control group exhibited a non-significant change in FMD values (from 12.2 +/- 7.2% at baseline to 11.9 +/- 4.0% at follow-up; p = 0.79). Group difference for observed 'FMD variation' was initially found to be significant (3.4%, CI = 0.6-5.8% and using generalised estimating equation p = 0.03). However, on repeating the analysis by taking stringent p values for establishing significance (p = 0.025), non-significant difference in FMD variation was seen. In the intervention group, all periodontal health parameters significantly improved over a period of six months (p <0.001, for all parameters) while inflammatory markers in both groups exhibited non-significant differences for the study period. No adverse outcomes were reported.Conclusions Treatment of periodontitis among patients with a recent episode of STEMI significantly improves the endothelial function as shown by improved FMD.
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