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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Collaborator: Sunstar Suisse
• Treatments: Betaine; Lactoferrin

Criteria

Inclusion Criteria:

• Use of a dry mouth product in the past 6 months

• Level of discomfort from dry mouth between 4 to 10 on a 0 (no discomfort) to 10 (extreme discomfort) scale

• Use of a dry mouth product at least 2-3 times per week

Exclusion Criteria:

• History of any treatment for cancer in the last 3 months

• Recurrence of cancer and end stage of it

• Being on a restrictive dietary regimen