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

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).

Conditions

• Xerostomia

Interventions

DRUG

Betaine taurine PVP gel

At the beginning of the trial (t0) each patient received a print-out summarizing the instructions for use of the products: they were instructed to apply during a 28 days treatment period 1 to 2 cm of GUM Hydral® gel to gums, oral mucosa membrane and tongue, repeating as many times as necessary, and to brush their teeth with GUM® Technique® Pro soft compact toothbrush (Sunstar Europe S.A., Etoy, Switzerland) using GUM® Hydral® Toothpaste (Sunstar Europe S.A., Etoy, Switzerland) at least twice a day. The first application was done by the participants themselves under the supervision of the same operator that provided them both oral and written usage instructions. They had to refrain from using any other commercial mouthrinse, toothpaste or saliva supplements during the trial.

DRUG

Xylitol, Lactoperoxidase, Lysozyme, Lactoferrin

At the beginning of the trial (t0) each patient received a print-out summarizing the instructions for use of the products: they were instructed to apply during a 28 days treatment period 1 to 2 cm of Biotene® Oral Balance gel to gums, oral mucosa membrane and tongue, repeating as many times as necessary, and to brush their teeth with GUM® Technique® Pro soft compact toothbrush (Sunstar Europe S.A., Etoy, Switzerland) using GUM® Hydral® Toothpaste (Sunstar Europe S.A., Etoy, Switzerland) at least twice a day. The first application was done by the participants themselves under the supervision of the same operator that provided them both oral and written usage instructions. They had to refrain from using any other commercial mouthrinse, toothpaste or saliva supplements during the trial.

Sponsors & Collaborators

• Sunstar Suisse

  collaborator UNKNOWN

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  lead OTHER

Principal Investigators

• Domenico Dalessandri, Prof. · Università degli Studi di Brescia

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-22

Primary Completion

2018-01-26

Completion

2018-10-30

Countries

• Italy

Study Locations