Dry MouthNCT03663231

Duration of Effect of Biotene Spray in Patients With Dry Mouth

A study testing Biotene in people with Dry Mouth, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Mouth
What is being tested?: Biotene
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2019to 22 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Eastman Dental Center
Rochester, New York, 14620

Other trials in United States

About this study

Official title: Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth

Conditions: Dry Mouth
Being tested: Biotene, Placebo
Medical subject headings: Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
PlaceboDevice
IND/IDE exempt device primarily water

Study groups in NCT03663231
Study group	Role	What they receive
Biotene	Experimental	People who present with dry mouth and will receive a single dose of Biotene. Receives: Device: Biotene
Placebo	Placebo comparator	People who present with dry mouth and will receive a single dose of an alternative agent. Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline up to 2 hours

Secondary outcomes (6)

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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 201922 Nov 2019

First posted10 Sep 2018
Study start11 Feb 2019
Primary completion22 Nov 2019
Study completion22 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry MouthStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03663231
Sponsor's protocol ID: 69726
Status last verified: Dec 2020
First submitted: 8 Aug 2018
Last updated: 20 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 33602603

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Mouth trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth
ClinicalTrials.gov ID: NCT03663231
Acronym / sponsor ID: 69726
Conditions: Dry Mouth
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Study start: 11 Feb 2019 (actual)
Primary completion: 22 Nov 2019 (actual)
Study completion: 22 Nov 2019 (actual)
First posted: 10 Sep 2018 (actual)
Results: Posted 20 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Biotene	Experimental	Device: BiotenePeople who present with dry mouth and will receive a single dose of Biotene.
Placebo	Placebo comparator	Device: PlaceboPeople who present with dry mouth and will receive a single dose of an alternative agent.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BioteneBiotène 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	Biotene
PlaceboIND/IDE exempt device primarily water	Device	Placebo

Primary outcome

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.

6 secondary outcomes

Mean Tolerability of Product
Time frame: 2 hours
Mean Acceptability of Product
Time frame: 2 hours
Mean Continued Use of Project
Time frame: 2 hours
Mean Purchase Product Rating
Time frame: 2 hours
Mean Ease of Use of Product
Time frame: 2 hours
Mean Preference for Another Product
Time frame: 2 hours

Results and safety

Results posted to the registry on 20 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biotene Then Placebo	16	14
Placebo Then Biotene	13	12

Primary outcome: Mean Duration of Action of Intervention

Time frame: baseline up to 2 hours. Mean (Standard Deviation). Unit: minutes

Measure	Biotene n = 26	Placebo n = 26
Value	27 (25)	26 (25)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biotene	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Placebo	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33602603Lung 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biotene in people with Dry Mouth, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Duration of Action of Intervention (time frame: baseline up to 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03663231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.