Duration of Effect of Biotene Spray in Patients With Dry Mouth

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT03663231
• Collaborator: (none)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Dry Mouth	Device: Biotene; Device: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 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: Feb 11, 2019
• Actual Primary Completion Date: Nov 22, 2019
• Actual Study Completion Date: Nov 22, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Duration of Action of Intervention [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.

Secondary Outcome Measures

1. Mean Tolerability of Product [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.

2. Mean Acceptability of Product [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.

3. Mean Continued Use of Project [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.

4. Mean Purchase Product Rating [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.

5. Mean Ease of Use of Product [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.

6. Mean Preference for Another Product [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Eastman Dental Center	Rochester	New York	United States	14620

Sponsors and Collaborators

• University of Rochester

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Jul 5, 2019
• Study Protocol and Statistical Analysis Plan - May 22, 2020

More Information

Publications

None provided.

• Responsible Party: Ralph Saunders, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03663231
• Other Study ID Numbers: 69726
• First Posted: Sep 10, 2018
• Last Update Posted: Jan 20, 2021
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Xerostomia

Study Results

Participant Flow

Pre-assignment Detail	37 subjects were enrolled. 8 subjects failed screening. 16 were randomized to either the Biotene then placebo arm and 13 were randomized to the water then Biotene arm.

Arm/Group Title	Biotene Then Placebo	Placebo Then Biotene
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Period Title: First Intervention
STARTED	16	13
COMPLETED	14	12
NOT COMPLETED	2	1
Period Title: First Intervention
STARTED	14	12
COMPLETED	14	12
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	14	12
COMPLETED	14	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Biotene Then Placebo	Placebo Then Biotene	Total
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water	Total of all reporting groups
Overall Participants	16	13	29
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 56.3%	10 76.9%	19 65.5%
>=65 years	6 37.5%	3 23.1%	9 31%
Sex: Female, Male (Count of Participants)
Female	12 75%	9 69.2%	21 72.4%
Male	4 25%	4 30.8%	8 27.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	0 0%	1 3.4%
Not Hispanic or Latino	15 93.8%	13 100%	28 96.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 25%	2 15.4%	6 20.7%
White	12 75%	11 84.6%	23 79.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%	13 100%	29 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	26	26
Mean (Standard Deviation) [minutes]	27 (25)	26 (25)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort.

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	4.2 (0.9)	3.8 (1.3)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort.

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	4.2 (0.9)	3.9 (1.1)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort.

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	3.1 (1.1)	2.9 (1.0)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort.

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	2.9 (1.1)	2.6 (0.9)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort.

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	4.0 (0.8)	3.9 (0.8)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data from 1 subject was excluded due to inability to comprehend the instructions for rating xerostomia-related oral discomfort.

Arm/Group Title	Biotene	Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.	People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
Measure Participants	25	25
Mean (Standard Deviation) [score on a scale]	3.2 (0.9)	3.4 (0.9)

Adverse Events

Time Frame	2 hours
Arm/Group Title	Biotene		Placebo
Arm/Group Description	People who present with dry mouth and will receive a single dose of Biotene. 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.		People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water
All Cause Mortality
	Biotene		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Serious Adverse Events
	Biotene		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Biotene		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.