Statistical analysis
SE, denture
RECRUITMENT, INFILTRATION, SECONDARY
For the pilot study, as the purpose was not to compare treatment arms but to understand if the food occlusion model was applicable to different patterns of adhesive application, the study was not blinded and no formal statistical analysis was performed. Approximately 48 (maximum 50) participants were planned to be enrolled. Recruitment was targeted to achieve 50 ± 10% of participants with low (score of 6–14, clinically fair to good denture retention and stability) or high (score of 15–18, clinically very good denture retention and stability) KO Index sum scores.In the efficacy study, it was planned to screen 53 participants and randomize 52 to ensure that 48 evaluable participants would complete the study. It was estimated that this sample size would provide 91% power to detect a multiplicative difference of 2.25 (0.3522 on the logarithmic scale) between the Test adhesive and no adhesive in the mean mass of peanut particles recovered from maxillary and mandibular dentures (based on the pilot study results). These were calculated using power analysis and sample size (PASS) software (NCSS Statistical Software, 2019) for a two‐period crossover trial and using the Sw option for the variability estimate as 0.5075. An extensive simulation conducted in the PASS study supported the above calculations.Primary and secondary efficacy analyses for both studies were based on a modified intent‐to‐treat (mITT) population, including all participants who were randomized, received at least one dose of study treatment, and had at least one assessment of efficacy. For the efficacy study, primary and secondary analysis of food infiltration was performed using a mixed model analysis of variance (ANOVA) with LogFor participants’ responses to questionnaires, descriptive statistics, mean score, and standard error (SE) were calculated for each question by the treatment group and frequency graphs were constructed. Analysis of participants’ responses to questions was performed using the methods described for the number of denture dislodgements.