Duration of Effect of Biotene Spray in Patients With Dry Mouth

Duration of Effect of Biotene Spray in Patients With Symptomatic Dry Mouth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03663231

Enrollment

Registered

2018-09-10

Start date

2019-02-11

Completion date

2019-11-22

Last updated

2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

DEVICEBiotene

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.

DEVICEPlacebo

IND/IDE exempt device primarily water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
Biotene Then Placebo 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.	16
Placebo Then Biotene People who present with dry mouth and will receive a single dose of an alternative agent. Placebo: IND/IDE exempt device primarily water	13
Total	29

Baseline characteristics

Characteristic	Total	Biotene Then Placebo	Placebo Then Biotene
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	9 Participants	6 Participants	3 Participants
Age, Categorical Between 18 and 65 years	19 Participants	9 Participants	10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	1 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants	15 Participants	13 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	6 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	23 Participants	12 Participants	11 Participants
Region of Enrollment United States	29 participants	16 participants	13 participants
Sex: Female, Male Female	21 Participants	12 Participants	9 Participants
Sex: Female, Male Male	8 Participants	4 Participants	4 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 29	0 / 29
other Total, other adverse events	0 / 29	0 / 29
serious Total, serious adverse events	0 / 29	0 / 29

Outcome results

Primary

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.

Time frame: baseline up to 2 hours

Arm	Measure	Value (MEAN)	Dispersion
Biotene	Mean Duration of Action of Intervention	27 minutes	Standard Deviation 25
Placebo	Mean Duration of Action of Intervention	26 minutes	Standard Deviation 25

Secondary

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.

Time frame: 2 hours