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OpenTrials
Completed

NCT Number: NCT03663231

Duration of Effect of Biotene Spray in Patients With 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Eastman Dental Center

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biotene

Device

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

Device

IND/IDE exempt device primarily water

Primary outcomes

  1. Mean Duration of Action of Intervention

    Time frame: baseline up to 2 hours

    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.

Secondary outcomes

  1. Mean Tolerability of Product

    Time frame: 2 hours

    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. Mean Acceptability of Product

    Time frame: 2 hours

    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.

  3. Mean Continued Use of Project

    Time frame: 2 hours

    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.

  4. Mean Purchase Product Rating

    Time frame: 2 hours

    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.

  5. Mean Ease of Use of Product

    Time frame: 2 hours

    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.

  6. Mean Preference for Another Product

    Time frame: 2 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 10, 2018
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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