Evaluation of the Efficacy of 3M Dry Mouth Moisturizing Spray

NCT04186806 | Completed Results FDA Device

• 1 other identifier: EM-11-050038
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (41)

• 10 cm Mean Mouth Dryness Visual Analog Score

  240 minutes post dose

• 10 cm Mouth Dryness Visual Analog Score

  240 minutes

• 10 cm Mean Mouth Dryness Visual Analog Score

  5 minutes

• 10 cm Mean Mouth Dryness Visual Analog Scale

  30 minutes

• 10 cm Mean Mouth Dryness Visual Analog Scale

  60 minutes

Study Arms (2)

3M Dry Mouth Moisturizing Spray

EXPERIMENTAL

Dry mouth agent

Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

Biotene Moisturizing Mouth Spray

ACTIVE COMPARATOR

Dry mouth agent

Device: 3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray; Device: Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray

Interventions

3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray DEVICE

20 ml bottle

3M Dry Mouth Moisturizing Spray; Biotene Moisturizing Mouth Spray

Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray DEVICE

44.3 ml bottle

3M Dry Mouth Moisturizing Spray; Biotene Moisturizing Mouth Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Loma Linda University, School of Dentistry

Loma Linda, California, 92350, United States

Location

Related Publications (5)

• 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.

  PMID: 8626175 BACKGROUND

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

  PMID: 9344281 BACKGROUND

• 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.

  PMID: 11488135 BACKGROUND

• 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.

  PMID: 15765951 BACKGROUND

• 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.

  PMID: 8626174 BACKGROUND

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Elaine Egging/Project Manger
• Organization: 3M Health Care

eegging@mmm.com

651-737-0263

Study Officials

• Yiming Li, DDS,MSD,PhD

  Loma Linda University, School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: December 5, 2019
• Study Start: November 2, 2019
• Primary Completion: December 13, 2019
• Study Completion: December 13, 2019
• Last Updated: October 2, 2024
• Results First Posted: November 20, 2020

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)