Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction
Status:
Completed
Trial end date:
2018-10-30
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia