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Trial record 3 of 698 for:    dry mouth

Duration of Effect of Biotene Spray in Patients With Dry Mouth

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ClinicalTrials.gov Identifier: NCT03663231
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : April 11, 2019
Sponsor:
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)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : September 15, 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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03663231


Contacts
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Contact: Christine Lung, MS 585-275-5087 christine_lung@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Eastman Dental Center Recruiting
Rochester, New York, United States, 14620
Contact: Christine Lung, MS    585-275-5087    Christine_Lung@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester

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Responsible Party: Ralph Saunders, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03663231     History of Changes
Other Study ID Numbers: 69726
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: January 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Muramidase
Anti-Infective Agents