Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms

The purpose of the clinical trial is to evaluate and validate the performance of the experimental mouth spray when used by persons with mild to severe dry mouth symptoms.

Study Overview

• Status: Completed
• Conditions: Xerostomia
• Intervention / Treatment: Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

Detailed Description

The purpose of this study is to investigate the efficacy of 3M Dry Mouth Moisturizing Spray to reduce symptoms of dry mouth for up to 4 hours and after 7 days of use. In addition, this study aims to support comparative claims.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • LOMA LINDA UNIVERSITY, School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Screening - Start of Wash-In Visit

• Subject who is ≥18 years of age and complains of dry mouth
• Only 1 subject per household is allowed into study
• Subject with a Challacombe scale score of 1 or higher
• Subject agrees to refrain from eating spicy foods and foods containing garlic beginning 48-hours prior to all study visits
• Subject agrees to eat a meal prior to all study visits that include sample evaluation in the clinic
• Subject agrees to not eat, drink, chew tobacco, chew gum, smoke, brush or floss teeth for 2-hours prior to sample evaluation study visits
• Subject agree to not use any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
• Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
• Subject agrees to only use those clinical oral care supplies provided during the entire study
• Able to understand and willing to sign the Informed Consent Form

Water Only Evaluation Visit

• Subject has successfully completed a ≥ 2-day wash-in period
• Subject has Challacombe scale score of 1 or higher
• Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to the sample evaluation visits
• Subject ate a meal prior to sample evaluation study visits
• Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
• Subject has not used any oral care products, any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
• Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
• Subject has used only those clinical oral care supplies provided during study

Baseline Period 1/Randomization Visit

• Subject has successfully completed a ≥ 2-day wash-in period
• Subject has a Challacombe Scale score of 1 or higher
• Subject has refrained from eating spicy foods and foods containing garlic beginning 48-hours prior to sample evaluation study visits
• Subject ate a meal prior to sample evaluation study visits
• Subject has not eaten, drank, chewed tobacco, chewed gum, smoked, brushed or flossed teeth for 2-hours prior to sample evaluation study visits
• Subject has not used any oral care products and any type of breath mint or lozenges for 2-hours prior to sample evaluation study visits
• Subject agrees to refrain from any food and liquid during the 5-hour study visits except for what is provided by the study research staff (e.g., water and treatments A and B during evaluation periods)
• Subject has used only those clinical oral care supplies provided during study

Exclusion Criteria:

Subject Exclusion Criteria for Start of Wash-In, Water Only Evaluation and Baseline Period 1 (Randomization Visit)

• Subject has active mouth sores (e.g., cold sores, cuts, burns, canker sores)
• Subject has a life-threatening pathological condition
• Subject is participating in another clinical trial at the time of the study
• Subject has profound marginal periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
• Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study
• Difficult to be compliant with recalls, such as extensive travel commitments, lack of transportation etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3M Dry Mouth Moisturizing Spray; Dry mouth agent	Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; 20 ml bottle; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray; 44.3 ml bottle
Active Comparator: Biotene Moisturizing Mouth Spray; Dry mouth agent	Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; 20 ml bottle; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray; 44.3 ml bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 cm Mouth Dryness Visual Analog Score	Primary endpoint will be paired-difference in Visual Analog Scale (VAS) between experimental and active control product. On the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms.	15 minutes post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 cm Mean Mouth Dryness Visual Analog Score	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms	240 minutes post dose
10 cm Mouth Dryness Visual Analog Score	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.	240 minutes
10 cm Mean Mouth Dryness Visual Analog Score	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms	5 minutes
10 cm Mean Mouth Dryness Visual Analog Scale	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms	30 minutes
10 cm Mean Mouth Dryness Visual Analog Scale	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms	60 minutes
10 cm Mean Mouth Dryness Visual Analog Scale	Mean Visual Analog Scale (VAS) on the scale 0 represents normal and 10 represents worst imaginable dry mouth symptoms	120 minutes
10 cm Mouth Dryness Visual Analog Scale	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.	5 minutes
10 cm Mouth Dryness Visual Analog Scale	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.	15 minutes
10 cm Mouth Dryness Visual Analog Scale	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.	30 minutes
10 cm Mouth Dryness Visual Analog Score	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.	60 minutes
10 cm Mouth Dryness Visual Analog Score	Paired-difference Visual Analog Scale (VAS) between both experimental and active control against water control. The range of possible values is -10 to +10. A negative value means is a better outcome than water. A positive value means is a worse outcome than water.	120 minutes
Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	5 minutes
Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	15 minutes
Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	30 minutes
Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	60 minutes
Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	120 minutes
Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	240 minutes
Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes
Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes
Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes
Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Yiming Li, DDS,MSD,PhD, LOMA LINDA UNIVERSITY, School of Dentistry

Publications and helpful links

General Publications

• Locker D. Xerostomia in older adults: a longitudinal study. Gerodontology. 1995 Jul;12(1):18-25. doi: 10.1111/j.1741-2358.1995.tb00125.x.
• Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
• Guijarro Guijarro B, Lopez Sanchez AF, Hernandez Vallejo G. Treatment of xerostomia. A review. Med Oral. 2001 Jan-Feb;6(1):7-18. English, Spanish.
• Fontana M, Zunt S, Eckert GJ, Zero D. A screening test for unstimulated salivary flow measurement. Oper Dent. 2005 Jan-Feb;30(1):3-8.
• Andersson G, Johansson G, Attstrom R, Edwardsson S, Glantz PO, Larsson K. Comparison of the effect of the linseed extract Salinum and a methyl cellulose preparation on the symptoms of dry mouth. Gerodontology. 1995 Jul;12(1):12-7. doi: 10.1111/j.1741-2358.1995.tb00124.x.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2019
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia; Anti-Infective Agents; Muramidase
• Other Study ID Numbers: EM-11-050038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No