drugset / Trial / NCT05342272

Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction

NCT05342272

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

Background. Xerostomia is estimated to affect up to 50% of the adult population and especially the elderly suffer from dry mouth sensation. Our aim was to compare the efficacy of GUM® Hydral® Moisturizing Gel and Biotene® Oral Balance Gel in dry mouth sensation reduction. Study design and Methods. Forty patients, reporting dry mouth sensation between 4 to 10 on a 0 (no discomfort) to 10 (extreme discomfort) scale, were divided in two parallel groups respectively treated with GUM® Hydral® and Biotene® Gel following a stratified randomization list (t0). Patients and the research assistants were blinded to group assignment. Patients underwent measurements of unstimulated and stimulated whole saliva flow and weekly (t1, t2, t3, t4) were asked to fill in a patient questionnaire and daily a journal to evaluate the dry mouth symptoms and the subjective perception of changes in the symptoms during one month of treatment. After data collection (t1-t4), patients were medically followed over the next six months in order to detect any long-term side effects (t5).

Timeline

Start
2017-09-22
Primary completion
2018-01-26
Completion
2018-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Betaine taurine PVP gel Unknown Topical
Comparator Lactoferrin Protein / enzyme biologic Topical
Comparator Lysozyme Unknown Topical
Comparator MYELOPEROXIDASE Protein / enzyme biologic Topical
Comparator Xylitol Small molecule Topical

Indications

No indication recorded.