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Duration of Effect of Biotene Spray in Patients With Dry Mouth

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ClinicalTrials.gov Identifier: NCT03663231
Recruitment Status : Completed
First Posted : September 10, 2018
Results First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ralph Saunders, University of Rochester

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE September 10, 2018
Results First Submitted Date  ICMJE November 18, 2020
Results First Posted Date  ICMJE January 20, 2021
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE February 11, 2019
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duration of Effect of Biotene Spray in Patients With Dry Mouth
Official Title  ICMJE Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Mouth
Intervention  ICMJE
  • 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.
  • Device: Placebo
    IND/IDE exempt device primarily water
Study Arms  ICMJE
  • Experimental: Biotene
    People who present with dry mouth and will receive a single dose of Biotene.
    Intervention: Device: Biotene
  • Placebo Comparator: Placebo
    People who present with dry mouth and will receive a single dose of an alternative agent.
    Intervention: Device: Placebo
Publications * Lung CB, Watson GE, Verma S, Feng C, Saunders RH. Duration of effect of Biotène 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2020)
37
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)
20
Actual Study Completion Date  ICMJE November 22, 2019
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03663231
Other Study ID Numbers  ICMJE 69726
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ralph Saunders, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rochester
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP