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A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water

NCT03494985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2018-09-26

Study results available
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Summary

This study assessed the efficacy of three dry mouth products (including an experimental Oralbalance gel, oral rinse, and moisturizing spray) to relieve the feeling of dry mouth compared to water, in dry mouth population over a period of 28 days.

Conditions

  • Xerostomia

Interventions

DEVICE

Experimental Oralbalance Moisturizing Gel

Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

DEVICE

Biotene Original Oral Rinse

Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

DEVICE

Biotene Moisturizing Mouth Spray

Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.

OTHER

Water

Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-17
Primary Completion
2014-01-10
Completion
2014-01-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03494985 on ClinicalTrials.gov