search
Back to results

Duration of Effect of Biotene Spray in Patients With Dry Mouth

Primary Purpose

Dry Mouth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biotene
Placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Mouth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Rochester Eastman Dental Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Biotene

Placebo

Arm Description

People who present with dry mouth and will receive a single dose of Biotene.

People who present with dry mouth and will receive a single dose of an alternative agent.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 8, 2018
Last Updated
December 27, 2020
Sponsor
University of Rochester
search

1. Study Identification

Unique Protocol Identification Number
NCT03663231
Brief Title
Duration of Effect of Biotene Spray in Patients With Dry Mouth
Official Title
Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biotene
Arm Type
Experimental
Arm Description
People who present with dry mouth and will receive a single dose of Biotene.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
People who present with dry mouth and will receive a single dose of an alternative agent.
Intervention Type
Device
Intervention Name(s)
Biotene
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
IND/IDE exempt device primarily water
Primary Outcome Measure Information:
Title
Mean Duration of Action of Intervention
Description
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.
Time Frame
baseline up to 2 hours
Secondary Outcome Measure Information:
Title
Mean Tolerability of Product
Description
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.
Time Frame
2 hours
Title
Mean Acceptability of Product
Description
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.
Time Frame
2 hours
Title
Mean Continued Use of Project
Description
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.
Time Frame
2 hours
Title
Mean Purchase Product Rating
Description
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.
Time Frame
2 hours
Title
Mean Ease of Use of Product
Description
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.
Time Frame
2 hours
Title
Mean Preference for Another Product
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
University of Rochester Eastman Dental Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33602603
Citation
Lung CB, Watson GE, Verma S, Feng C, Saunders RH. Duration of effect of Biotene 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.
Results Reference
derived

Learn more about this trial

Duration of Effect of Biotene Spray in Patients With Dry Mouth

We'll reach out to this number within 24 hrs