Clinical trial NCT04186806: Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray
Official title: An Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray on the Relief of Dry Mouth Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2019-12-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All subjects completing the wash-in procedures and meeting inclusion/exclusion criteria will undergo a pre-study 5-hour visit (the day before randomization) to assess the effect of water on their dry mouth symptoms. The subjects will return the next day for confirmation that inclusion/exclusion criteria and the wash-in procedures continue to be met or followed. Eligible subjects will be randomized at this baseline visit in a 1:1 ratio to one of two treatment orders: A-\>B (AB) or B-\>A (BA).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10 cm Mouth Dryness Visual Analog Score
timeFrame: 15 minutes post dose
Secondary outcomes:
measure: 10 cm Mean Mouth Dryness Visual Analog Score
timeFrame: 240 minutes post dose
measure: 10 cm Mouth Dryness Visual Analog Score
timeFrame: 240 minutes
measure: 10 cm Mean Mouth Dryness Visual Analog Score
timeFrame: 5 minutes
measure: 10 cm Mean Mouth Dryness Visual Analog Scale
timeFrame: 30 minutes
measure: 10 cm Mean Mouth Dryness Visual Analog Scale
timeFrame: 60 minutes
measure: 10 cm Mean Mouth Dryness Visual Analog Scale
timeFrame: 120 minutes
measure: 10 cm Mouth Dryness Visual Analog Scale
timeFrame: 5 minutes
measure: 10 cm Mouth Dryness Visual Analog Scale
timeFrame: 15 minutes
measure: 10 cm Mouth Dryness Visual Analog Scale
timeFrame: 30 minutes
measure: 10 cm Mouth Dryness Visual Analog Score
timeFrame: 60 minutes
measure: 10 cm Mouth Dryness Visual Analog Score
timeFrame: 120 minutes
measure: Response on Dry Mouth Relief
timeFrame: 5 minutes
measure: Response on Dry Mouth Relief
timeFrame: 15 minutes
measure: Response on Dry Mouth Relief
timeFrame: 30 minutes
measure: Response on Dry Mouth Relief
timeFrame: 60 minutes
measure: Response on Dry Mouth Relief
timeFrame: 120 minutes
measure: Response on Dry Mouth Relief
timeFrame: 240 minutes
measure: Response to Effectively Lubricates the Mouth
timeFrame: 5 minutes
measure: Response to Effectively Lubricates the Mouth
timeFrame: 15 minutes
measure: Response to Effectively Lubricates the Mouth
timeFrame: 30 minutes
measure: Response to Effectively Lubricates the Mouth
timeFrame: 60 minutes
measure: Response to Effectively Lubricates the Mouth
timeFrame: 120 minutes
measure: Response to Effectively Lubricates the Mouth
timeFrame: 240 minutes
measure: Response to Feel Comfortable in the Mouth
timeFrame: 5 minutes
measure: Response to Feel Comfortable in the Mouth
timeFrame: 15 minutes
measure: Response to Feel Comfortable in the Mouth
timeFrame: 30 minutes
measure: Response to Feel Comfortable in the Mouth
timeFrame: 60 minutes
measure: Response to Feel Comfortable in the Mouth
timeFrame: 120 minutes
measure: Response to Feel Comfortable in the Mouth
timeFrame: 240 minutes
measure: Response to Soothing in the Mouth
timeFrame: 5 minutes
measure: Response to Soothing in the Mouth
timeFrame: 15 minutes
measure: Response to Soothing in the Mouth
timeFrame: 30 minutes
measure: Response to Soothing in the Mouth
timeFrame: 60 minutes
measure: Response to Soothing in the Mouth
timeFrame: 120 minutes
measure: Response to Soothing in the Mouth
timeFrame: 240 minutes
measure: Response to Effectively Moistens the Mouth
timeFrame: 5 minutes
measure: Response to Effectively Moistens the Mouth
timeFrame: 15 minutes
measure: Response to Effectively Moistens the Mouth
timeFrame: 30 minutes
measure: Response to Effectively Moistens the Mouth
timeFrame: 60 minutes
measure: Response to Effectively Moistens the Mouth
timeFrame: 120 minutes
measure: Response to Effectively Moistens the Mouth
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University, School of Dentistry
state: California
Study officials:
affiliation: Loma Linda University, School of Dentistry
name: Yiming Li, DDS,MSD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
citation: 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.
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.
citation: 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.