NCT03663231

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 20, 2021

Completed
Last Updated

January 20, 2021

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

August 8, 2018

Results QC Date

November 18, 2020

Last Update Submit

December 27, 2020

Conditions

Dry Mouth

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline up to 2 hours

Secondary Outcomes (6)

  • Mean Tolerability of Product

    2 hours

  • Mean Acceptability of Product

    2 hours

  • Mean Continued Use of Project

    2 hours

  • Mean Purchase Product Rating

    2 hours

  • Mean Ease of Use of Product

    2 hours

  • +1 more secondary outcomes

Study Arms (2)

Biotene

EXPERIMENTAL

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

Device: Biotene

Placebo

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

BioteneDEVICE

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.

Biotene
PlaceboDEVICE

IND/IDE exempt device primarily water

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Eastman Dental Center

Rochester, New York, 14620, United States

Location

Related Publications (1)

  • 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.

    PMID: 33602603DERIVED

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Ralph Saunders
Organization
University of Rochester
ralph_saunders@urmc.rochester.edu
585-275-1141

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2018

First Posted

September 10, 2018

Study Start

February 11, 2019

Primary Completion

November 22, 2019

Study Completion

November 22, 2019

Last Updated

January 20, 2021

Results First Posted

January 20, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)