NCT03494985

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

A Clinical Study to Evaluate the Efficacy of an Experimental Oralbalance Gel, Oral Rinse and Spray Versus Water

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 35 Years – 84 Years
• Healthy volunteers: Accepted

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.

Detailed description

This was a multi-centered (two-sites), examiner-blinded, four treatment arms, stratified (by Modified Dry Mouth Inventory \[DMI\] score), randomized, parallel group study in participants with self-reported dry mouth symptoms as determined by participant responses to the DMI. Participants used their assigned dry mouth treatment at home for 28 days.

Conditions

• Xerostomia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-09-17
• Primary completion: 2014-01-10
• Completion: 2014-01-10
• First posted: 2018-04-11
• Last updated: 2018-09-26
• Results posted: 2018-07-18