Duration of Effect of Biotene Spray in Patients With Dry Mouth

Dry Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663231
• Other study ID #: 69726
• Status: Completed
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: November 22, 2019

Study information

• Verified date: December 2020
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Mouth
• Xerostomia

Intervention

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
IND/IDE exempt device primarily water

Locations

Country	Name	City	State
United States	University of Rochester Eastman Dental Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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