Clinical Evaluation of a Polyethylene Glycol Derivative Rinse for Xerostomia

Background/Objectives: This study aimed to evaluate the effect of a mouth rinse, MucoPEG™, containing a polyethylene glycol derivative, on oral dryness, compared to Biotène^® Dry Mouth Gentle Oral Rinse (Biotène^®). Methods: Forty-two subjects with mild oral dryness with a Challacombe scale score of 1 or more were enrolled in the study across two sites using an open-label randomized crossover design. Subjects used either Biotène^® or MucoPEG™ twice daily for two weeks (Period 1) with a one-week washout period and then crossed over to the other product for two weeks (Period 2). The subjects provided a rating on a Visual Analogue Scale (VAS) for tongue and oral dryness and completed the Dry Mouth Relief Questionnaire (DMRQ), Dry Mouth Product Performance and Attributes Questionnaire (PPAQ), and Dry Mouth Inventory (DMI). Results: Both MucoPEG™ and Biotène^® demonstrated overall improvements in oral dryness symptoms with no statistically significant difference observed between products when both periods were combined. However, a statistically significant difference favoring MucoPEG™ was observed during Period 2. No significant sequence or period effects were detected. DMRQ and DMI responses were generally comparable between products. However, MucoPEG™ was associated with higher patient-reported ratings for sustained moisturizing and lubricating effects at 240 min post-application on the PPAQ only. No adverse events were reported. Conclusions: In this study MucoPEG™ demonstrated clinical performance comparable to that of Biotène^® in improving symptoms of oral dryness and was well tolerated. Although outcomes showed no significant differences between the two products, a subset of patient-reported outcomes suggests a potential advantage of MucoPEG™ in sustained symptom relief, consistent with its PEG-derivative formulation mechanism. However, these observations require validation. Further studies using parallel-group designs may help to clarify potential differences in long-term and sustained efficacy, thereby supporting the potential value of MucoPEG™ as an alternative therapeutic option for the management of xerostomia.