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

NCT05342272 | Completed Phase 3

• 1 other identifier: NP2789
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Surveys and Questionnaires

Outcome Measures

Primary Outcomes (1)

• Dry mouth sensation relief change

  Patients were asked to complete a "patient questionnaire" at the same time of the day at t0, t1 (after 1st week), t2 (2nd week), t3 (3rd week) and at the end of the trial, t4 (4th week), and a "daily journal". The "patient questionnaire" was used to record the severity of the dry mouth sensation and changes in the symptoms (thanks to a VAS scale and dichotomous variables). In the "daily journal", patients indicated on a dedicated calendar the times of product use, they reported their subjective sensation of oral dryness 3 times a day on a Visual Analogue Scale (VAS) ranging from 0 (well lubricated mouth) to 10 (worst possible dry mouth feeling), and they answered the following two questions: "How many minutes after the use of the gel did you feel dry mouth relief?" and "How long (expressed in minutes) did the dry mouth relief last (after the use of the gel)?" to record the perceived speed and duration of effects of the products and their pleasantness of use.

  Beginning, after 1 - 2 - 3 - 4 weeks, after 6 months

Study Arms (2)

GUM Hydral Moisturizing Gel

EXPERIMENTAL

One group of 20 patients receiving GUM® Hydral® Moisturizing Gel (test group): they were be instructed to apply during a 28 days treatment period 1 to 2 cm of gel to gums, oral mucosa membrane and tongue, repeating as many times as necessary.

Drug: Betaine taurine PVP gel

Biotene Oral Balance Gel

ACTIVE COMPARATOR

One group of 20 patients receiving Biotene® Oral Balance Gel (control group): they were be instructed to apply during a 28 days treatment period 1 to 2 cm of gel to gums, oral mucosa membrane and tongue, repeating as many times as necessary.

Drug: Xylitol, Lactoperoxidase, Lysozyme, Lactoferrin

Interventions

Betaine taurine PVP gel DRUG

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.

Also known as: GUM Hydral® Gel

GUM Hydral Moisturizing Gel

Xylitol, Lactoperoxidase, Lysozyme, Lactoferrin DRUG

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.

Also known as: Biotene® Oral Balance Gel

Biotene Oral Balance Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Sunstar Suisse: collaborator

Study Sites (2)

ASST Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

ASST Spedali Civili di Brescia

Brescia, Italy

Location

MeSH Terms

Conditions

Xerostomia

Interventions

Xylitol; Lactoperoxidase; Muramidase; Lactoferrin

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Peroxidases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Glycoside Hydrolases; Hydrolases; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Serine Proteases; Glycoproteins; Glycoconjugates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• Domenico Dalessandri, Prof.

  Università degli Studi di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: April 22, 2022
• Study Start: September 22, 2017
• Primary Completion: January 26, 2018
• Study Completion: October 30, 2018
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)