Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

Xerostomia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04186806
• Other study ID #: EM-11-050038
• Status: Completed
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: November 2020
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Xerostomia

Intervention

Device:
• 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray
20 ml bottle
• Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray
44.3 ml bottle

Locations

Country	Name	City	State
United States	Loma Linda University, School of Dentistry	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

References & Publications (5)

Andersson G, Johansson G, Attström 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. — View Citation

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. — View Citation

Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75. Review. — View Citation

Guijarro Guijarro B, López Sánchez AF, Hernández Vallejo G. Treatment of xerostomia. A review. Med Oral. 2001 Jan-Feb;6(1):7-18. Review. English, Spanish. — View Citation

Locker D. Xerostomia in older adults: a longitudinal study. Gerodontology. 1995 Jul;12(1):18-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	5 minutes
Secondary	Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	15 minutes
Secondary	Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	30 minutes
Secondary	Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	60 minutes
Secondary	Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	120 minutes
Secondary	Response on Dry Mouth Relief	Count of each category of the ordinal scale 0 = No Relief and 4 = Significant/Excellent	240 minutes
Secondary	Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Secondary	Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Secondary	Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Secondary	Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Secondary	Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Secondary	Response to Effectively Lubricates the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes
Secondary	Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Secondary	Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Secondary	Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Secondary	Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Secondary	Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Secondary	Response to Feel Comfortable in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes
Secondary	Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Secondary	Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Secondary	Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Secondary	Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Secondary	Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Secondary	Response to Soothing in the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes
Secondary	Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	5 minutes
Secondary	Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	15 minutes
Secondary	Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	30 minutes
Secondary	Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	60 minutes
Secondary	Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	120 minutes
Secondary	Response to Effectively Moistens the Mouth	5 point ordinal scale 1 = Poor and 5 = Excellent	240 minutes