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Duration of Effect of Biotene Spray in Patients With Dry Mouth

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ClinicalTrials.gov Identifier: NCT03663231
Recruitment Status : Completed
First Posted : September 10, 2018
Results First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ralph Saunders, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Mouth
Interventions Device: Biotene
Device: Placebo
Enrollment 37
Recruitment Details  
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.
Arm/Group Title Biotene Then Placebo Placebo Then Biotene
Hide 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: Washout
Started 14 12
Completed 14 12
Not Completed 0 0
Period Title: Second Intervention
Started 14 12
Completed 14 12
Not Completed 0 0
Arm/Group Title Biotene Then Placebo Placebo Then Biotene Total
Hide 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 Number of Baseline Participants 16 13 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 13 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  60.0%
10
  76.9%
19
  67.9%
>=65 years
6
  40.0%
3
  23.1%
9
  32.1%
[1]
Measure Analysis Population Description: One participant did not have data collected for age in the Biotene then Placebo arm.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Female
12
  75.0%
9
  69.2%
21
  72.4%
Male
4
  25.0%
4
  30.8%
8
  27.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
Hispanic or Latino
1
   6.3%
0
   0.0%
1
   3.4%
Not Hispanic or Latino
15
  93.8%
13
 100.0%
28
  96.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 13 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  25.0%
2
  15.4%
6
  20.7%
White
12
  75.0%
11
  84.6%
23
  79.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 13 participants 29 participants
16 13 29
1.Primary Outcome
Title Mean Duration of Action of Intervention
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biotene Placebo
Hide 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

Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: minutes
27  (25) 26  (25)
2.Secondary Outcome
Title Mean Tolerability of Product
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.2  (0.9) 3.8  (1.3)
3.Secondary Outcome
Title Mean Acceptability of Product
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.2  (0.9) 3.9  (1.1)
4.Secondary Outcome
Title Mean Continued Use of Project
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.1  (1.1) 2.9  (1.0)
5.Secondary Outcome
Title Mean Purchase Product Rating
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.9  (1.1) 2.6  (0.9)
6.Secondary Outcome
Title Mean Ease of Use of Product
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.0  (0.8) 3.9  (0.8)
7.Secondary Outcome
Title Mean Preference for Another Product
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.2  (0.9) 3.4  (0.9)
Time Frame 2 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biotene Placebo
Hide 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 (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%) 
Hide Serious Adverse Events
Biotene Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biotene Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/29 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ralph Saunders
Organization: University of Rochester
Phone: 585-275-1141
EMail: ralph_saunders@urmc.rochester.edu
Layout table for additonal information
Responsible Party: Ralph Saunders, University of Rochester
ClinicalTrials.gov Identifier: NCT03663231    
Other Study ID Numbers: 69726
First Submitted: August 8, 2018
First Posted: September 10, 2018
Results First Submitted: November 18, 2020
Results First Posted: January 20, 2021
Last Update Posted: January 20, 2021