A Randomized Clinical Trial to Measure Mouth Moisturization and Dry Mouth Relief in Dry Mouth Subjects Using Dry Mouth Products

Anto Jose, Mounir Atassi, Lucy Shneyer, Matthew Cronin

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

OBJECTIVES: This study examined ratings of two subjective aspects (moisturization and dry mouth relief) that may be changed following the use of dry mouth relief products (an oral gel, an oral rinse, or a mouth spray), in comparison to water over a period of four hours following a single supervised use on two separate occasions.

METHODS: This was a single-center, two site, randomized, examiner blind, four treatment arm, stratified (by dry mouth screening score at baseline), parallel group study in healthy subjects with a self-reported feeling of dry mouth. Prior to product use, subjects rated their current subjective perception of moisturization and dry mouth on an 11-point scale. Subjects then rated the two questions immediately after product use and 30, 60, 90, 120, and 240 minutes later. At the 240-minute time point, subjects also rated global efficacy questions regarding "overall" and "long-lasting" moisturization and dry mouth relief, and overall product opinion. Subjects then used their assigned products at home for three days and the procedures were repeated on Day 4.

RESULTS: In total, 300 subjects were randomized to treatment. Compared with water, all test products showed statistically significantly greater improvements over baseline on both Day 1 and Day 4 at most time points, on the area under the curve from baseline for the moisturization and dryness questions, and after 240 minutes for the global efficacy and overall opinion assessments (all p < 0.05). There was a statistically significant difference between the pre-dosing assessments on Day 1 versus Day 4 (p < 0.001) for both efficacy questions. Products were generally well-tolerated.

CONCLUSIONS: Three different types of dry mouth relief products were shown to provide significant relief of dry mouth and increased feelings of moisturization compared to water using subjective questionnaires.

Original languageEnglish
Pages (from-to)32-38
Number of pages7
JournalThe Journal of clinical dentistry
Volume28
Issue number2
Publication statusPublished - Jun 2017

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Mouth
Randomized Controlled Trials
Water
Emotions
Area Under Curve
Healthy Volunteers
Arm
Gels
Therapeutics

Keywords

  • Journal Article
  • dry mouth
  • moisturization
  • oral rinse
  • oral spray
  • oral gel

Cite this

A Randomized Clinical Trial to Measure Mouth Moisturization and Dry Mouth Relief in Dry Mouth Subjects Using Dry Mouth Products. / Jose, Anto; Atassi, Mounir; Shneyer, Lucy; Cronin, Matthew.

In: The Journal of clinical dentistry, Vol. 28, No. 2, 06.2017, p. 32-38.

Research output: Contribution to journalArticle

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AB - OBJECTIVES: This study examined ratings of two subjective aspects (moisturization and dry mouth relief) that may be changed following the use of dry mouth relief products (an oral gel, an oral rinse, or a mouth spray), in comparison to water over a period of four hours following a single supervised use on two separate occasions.METHODS: This was a single-center, two site, randomized, examiner blind, four treatment arm, stratified (by dry mouth screening score at baseline), parallel group study in healthy subjects with a self-reported feeling of dry mouth. Prior to product use, subjects rated their current subjective perception of moisturization and dry mouth on an 11-point scale. Subjects then rated the two questions immediately after product use and 30, 60, 90, 120, and 240 minutes later. At the 240-minute time point, subjects also rated global efficacy questions regarding "overall" and "long-lasting" moisturization and dry mouth relief, and overall product opinion. Subjects then used their assigned products at home for three days and the procedures were repeated on Day 4.RESULTS: In total, 300 subjects were randomized to treatment. Compared with water, all test products showed statistically significantly greater improvements over baseline on both Day 1 and Day 4 at most time points, on the area under the curve from baseline for the moisturization and dryness questions, and after 240 minutes for the global efficacy and overall opinion assessments (all p < 0.05). There was a statistically significant difference between the pre-dosing assessments on Day 1 versus Day 4 (p < 0.001) for both efficacy questions. Products were generally well-tolerated.CONCLUSIONS: Three different types of dry mouth relief products were shown to provide significant relief of dry mouth and increased feelings of moisturization compared to water using subjective questionnaires.

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