Duration of Effect of Biotene Spray in Patients With Dry Mouth

Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth

To determine the duration of effect of a single dose of Biotène Moisturizing Mouth Spray in subjects who complain of a clinically dry mouth. The effect of the product will be compared to a control spray (water).

Study Overview

• Status: Completed
• Conditions: Dry Mouth
• Intervention / Treatment: Device: Biotene; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester Eastman Dental Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults who are in good general health and reply initially affirmatively to the question, "Do you feel that your mouth is too dry and causes you discomfort at times during the day other than on awakening from sleep?" This question is an adaptation of the question used successfully by Jose and others (2016) to recruit study subjects.
• Adults who are able to communicate easily in English and who are able to demonstrate understanding of the study instructions.
• Adults who are physically able to perform an unstimulated whole saliva flow rate (UWSFR) test and who produce 0.2 mL/min or less of saliva.

Exclusion Criteria:

• Adults under the care of a health professional specifically for xerostomia treatment, including those taking prescription systemic parasympathetic medications.
• Adults who regularly "self-medicate" their xerostomia with water or other agents or products designed to treat their xerostomia and are unwilling or unable to cease use of the agent for at least 48 hours prior to the two test visits.
• Adults who are primarily mouth breathers (i.e. mouth breathing secondary to nasal obstruction)
• Adults who cannot consent for themselves or have physical/mental disabilities requiring a caregiver.
• Adults with a known allergy to any of the ingredients in Biotène Spray (eg. dairy allergy)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biotene; People who present with dry mouth and will receive a single dose of Biotene.	Device: Biotene; Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL.
Placebo Comparator: Placebo; People who present with dry mouth and will receive a single dose of an alternative agent.	Device: Placebo; IND/IDE exempt device primarily water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Duration of Action of Intervention	Participant will receive a dose of Biotene or placebo (water) and will be asked if their mouth is dry up to 2 hrs. The time at which their mouth becomes dry again will be the duration of action.	baseline up to 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Tolerability of Product	Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The taste of the product was tolerable.	2 hours
Mean Acceptability of Product	Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: The thickness of the product was acceptable.	2 hours
Mean Continued Use of Project	Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would like to continue using this product.	2 hours
Mean Purchase Product Rating	Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would purchase this product to use on a regular basis.	2 hours
Mean Ease of Use of Product	Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: This product is easy to use.	2 hours
Mean Preference for Another Product	Subjects were asked to agree or disagree with the following statement where 1= strongly agree and 5- strongly disagree: I would prefer using another product.	2 hours

Collaborators and Investigators

• Sponsor: University of Rochester

Publications and helpful links

General Publications

• Lung CB, Watson GE, Verma S, Feng C, Saunders RH. Duration of effect of Biotene spray in patients with symptomatic dry mouth: A pilot study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2021 Apr;131(4):415-421. doi: 10.1016/j.oooo.2020.12.002. Epub 2021 Jan 16.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: December 27, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: 69726

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