Pakistan Journal of Pharmaceutical Sciences

Abstract: Background: Dry mouth is a condition associated with significant morbidity. It not only causes discomfort but also increases risk of many health and oral health problems. Objectives: This study compared the efficacy and patient satisfaction of a novel sesame oil wafer, called “Freeze-Dried Sesame Oil Emulsion Salivary Substitute (FD-SOESS),” with ACT® lozenges in managing dry mouth in patients who had undergone treatment for head and neck cancer. Methods: A randomized, single-blind, crossover trial was conducted in 35 patients. Subjective dry mouth (Shortening Xerostomia Inventory), objective dry mouth (Clinical Oral Dryness Score, CODS), dysphagia (Eating Assessment Tool-10, EAT-10) and oral mucositis (WHO Oral Toxicity Scale) were assessed before and after 2 weeks of use. Satisfaction was rated using a visual analog scale (VAS 0-10). Outcomes were compared using paired t-tests and Wilcoxon signed-rank tests at a significance level of 0.05. Results: Both products showed significant improvements in objective dry mouth. While the lozenges group showed a borderline significant improvement in subjective dry mouth (P=0.037). Notably, the FD-SOESS group demonstrated significant improvement in dysphagia scores (P=0.003). Satisfaction levels were moderate to high in both groups, with slightly higher levels in the FD-SOESS group. Conclusion: To conclude, FD-SOESS significantly improved objective dry mouth and dysphagia but not subjective dry mouth. It received a relatively high level of satisfaction. Therefore, this newly developed product has the potential to be an alternative product for dry mouth patients.