Results
thirty-four, OLP
ADVERSE EFFECTS, SYSTEMIC DISEASE, RECRUITMENT
During the recruitment phase, 36 patients were assessed for eligibility from September 2019 to February 2022. Two patients did not meet the inclusion criteria due to their chronic systemic diseases. Only thirty-four participants were eligible for inclusion. All patients gave written informed consent and were randomly allocated equally to the intervention group (CONSORT flow diagram of participantsDemographic data of age and genderClinical characteristics of symptomatic OLP lesions in both groupsAfter the 4 week follow up period, both the intervention group and control group showed a significant difference in VAS scores at different follow-up intervals (Mean and standard deviation (SD) of VAS scores in both groups and different follow-up intervalsDifferent superscript letters within the same column indicate a statistically significant difference*; significant (Regarding the (mean ± SD) value of lesion size using the (Thongprasom scale), the intervention group showed a significant difference between lesion sizes at different follow-up intervals (Mean and standard deviation of lesion size in (Thongprasom scale) in both groups and different follow-up intervalsDifferent superscript letters within the same column indicate a statistically significant difference*; significant (Line chart showing average lesion size in (Thongprasom scale) in different follow-up intervalsIn addition to the clinical assessment, the salivary level of malondialdehyde (pg/ml) before and after the treatment in both groups was assessed which showed that the intervention group value of salivary level of malondialdehyde (pg/ml) measured before (7.08 ± 4.46) was higher than value measured after treatment (5.92 ± 2.73), however the difference was not statistically significant (Mean and standard deviation of salivary level of malondialdehyde (pg/ml) in both groups and different follow-up intervals
Line chart showing the average salivary level of malondialdehyde (pg/ml) at different follow-up intervalsFinally, PGI-C assessing patient experience with their OLP at end of dosing also showed clinically meaningful improvements in both groups with 12/17 patients (70.5%) in mucoadhesive Coq10 intervention group and 14/17 patients (82.3%) in the control group reporting their OLP feeling much better or very much better.Regarding drug safety in both groups, none of the participants in either group reported any temporary or permanent adverse effects with either treatment during the 4 week follow up period.