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Duration of Effect of Biotene Spray in Patients With Dry Mouth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03663231
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Ralph Saunders, University of Rochester

Brief 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).

Condition or disease Intervention/treatment Phase
Dry Mouth Device: Biotene Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
Actual Study Start Date : February 11, 2019
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dry Mouth

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

Primary Outcome Measures :
  1. mean duration of action of intervention [ Time Frame: baseline up to 2 hours ]
    Participant will receive a dose of Biotene 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.

Secondary Outcome Measures :
  1. mean subject evaluation of test reagent [ Time Frame: 2 hours ]
    Subjects will be given a 10 question survey that assesses their tolerability, acceptability, and ease of use of product. The range of the questionnaire score is 1-30 with 30 indicating better outcomes.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03663231

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United States, New York
University of Rochester Eastman Dental Center
Rochester, New York, United States, 14620
Sponsors and Collaborators
University of Rochester
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Responsible Party: Ralph Saunders, Professor, University of Rochester Identifier: NCT03663231    
Other Study ID Numbers: 69726
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases