Trial Outcomes & Findings for Blinded Dry Mouth Spray Crossover Study (NCT NCT04608773)
NCT ID: NCT04608773
Last Updated: 2024-02-01
Results Overview
at the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics. Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"
COMPLETED
NA
129 participants
2 week trial period
2024-02-01
Participant Flow
1824 patients were screened for eligibility at UPMC's Head and Neck Cancer Survivorship Clinic between January 2021 and September 2022.
468 patients were found eligible, 339 declined to participate and 129 were enrolled.
Participant milestones
| Measure |
Biotene Spray, Followed by Refresh Spray
The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)
Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
|
Refresh Spray, Followed by Biotene Spray
The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)
Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
|
|---|---|---|
|
First Wash Out (1 Week)
STARTED
|
69
|
60
|
|
First Wash Out (1 Week)
COMPLETED
|
57
|
54
|
|
First Wash Out (1 Week)
NOT COMPLETED
|
12
|
6
|
|
First Intervention (2 Weeks)
STARTED
|
57
|
54
|
|
First Intervention (2 Weeks)
COMPLETED
|
53
|
50
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
4
|
4
|
|
Second Wash Out (1 Week)
STARTED
|
53
|
50
|
|
Second Wash Out (1 Week)
COMPLETED
|
53
|
50
|
|
Second Wash Out (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Week)
STARTED
|
53
|
50
|
|
Second Intervention (2 Week)
COMPLETED
|
51
|
45
|
|
Second Intervention (2 Week)
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
Biotene Spray, Followed by Refresh Spray
The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)
Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
|
Refresh Spray, Followed by Biotene Spray
The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)
Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
|
|---|---|---|
|
First Wash Out (1 Week)
Withdrawal by Subject
|
12
|
6
|
|
First Intervention (2 Weeks)
Lost to Follow-up
|
3
|
1
|
|
First Intervention (2 Weeks)
mild adverse effects
|
1
|
3
|
|
Second Intervention (2 Week)
Lost to Follow-up
|
2
|
4
|
|
Second Intervention (2 Week)
mild adverse effect
|
0
|
1
|
Baseline Characteristics
Only participants who completed the protocol were included in the analysis.
Baseline characteristics by cohort
| Measure |
Biotene Spray, Followed by Refresh Spray
n=69 Participants
The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)
Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
|
Refresh Spray, Followed by Biotene Spray
n=60 Participants
The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)
Remineralizing Extreme Dry Mouth Spray with Xylitol: oral hydrating spray
Alcohol-Free Moisturizing Dry Mouth Spray: oral hydrating spray
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
4 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
5 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
56 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
124 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=7 Participants • Only participants who completed the protocol were included in the analysis.
|
0 Participants
n=5 Participants • Only participants who completed the protocol were included in the analysis.
|
|
Region of Enrollment
United States
|
69 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Drymouth baseline
|
44.0 units on a scale
STANDARD_DEVIATION 20.6 • n=5 Participants
|
39.2 units on a scale
STANDARD_DEVIATION 21.8 • n=7 Participants
|
42.4 units on a scale
STANDARD_DEVIATION 21.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 week trial periodat the end of each study period an online questionnaire was administered. The questionnaire included continuous variables derived from the 100mm visual analog scale (VAS); documented via questionnaire completion by participants administered via Qualtrics. Dryness was measured on a 0-100 point scale "During the last three days, overall, your mouth or tongue was: 'Very Dry' = 0 10 20 30 40 50 60 70 80 90 100 = 'Not at All Dry"
Outcome measures
| Measure |
Biotene Spray
n=96 Participants
Participants who received Biotene in either the first or last two week trial period of the study.
|
Refresh Spray
n=96 Participants
Participants who received Refresh spray in either the first or second two week period of the study.
|
|---|---|---|
|
Oral Dryness
Oral dryness Dryness baseline
|
45.5 units on a scale
Standard Deviation 20.3
|
46.6 units on a scale
Standard Deviation 22.7
|
|
Oral Dryness
Dryness 2 weeks
|
52.76 units on a scale
Standard Deviation 19.25
|
54.1 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: 2 week trialPopulation: Number of participants in analysis is less than overall number of participants due to missing responses.
sleeping difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Sleeping difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to sleep? Consider such factors as how difficult it was for you to go to sleep, the duration and quality of your sleep, and how often you woke up to drink or urinate. Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy" (Higher score means better outcome)
Outcome measures
| Measure |
Biotene Spray
n=96 Participants
Participants who received Biotene in either the first or last two week trial period of the study.
|
Refresh Spray
n=96 Participants
Participants who received Refresh spray in either the first or second two week period of the study.
|
|---|---|---|
|
Sleeping Difficulty Due to Oral Dryness
Sleep Baseline
|
56.3 units on a scale
Standard Deviation 27.0
|
61.9 units on a scale
Standard Deviation 26.3
|
|
Sleeping Difficulty Due to Oral Dryness
Sleep 2 weeks
|
66.8 units on a scale
Standard Deviation 23.0
|
64.8 units on a scale
Standard Deviation 24.9
|
SECONDARY outcome
Timeframe: 2 week trialPopulation: The number of participants in analysis are lower in this specific analysis due to missing data
Speaking difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Speaking difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to speak without drinking liquids? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"
Outcome measures
| Measure |
Biotene Spray
n=96 Participants
Participants who received Biotene in either the first or last two week trial period of the study.
|
Refresh Spray
n=96 Participants
Participants who received Refresh spray in either the first or second two week period of the study.
|
|---|---|---|
|
Speaking Difficulty Due to Oral Dryness
speaking baseline
|
60.8 units on a scale
Standard Deviation 27.6
|
63.0 units on a scale
Standard Deviation 26.6
|
|
Speaking Difficulty Due to Oral Dryness
speaking 2 weeks
|
69.9 units on a scale
Standard Deviation 22.2
|
66.8 units on a scale
Standard Deviation 24.1
|
SECONDARY outcome
Timeframe: 2 week trialPopulation: The number of participants in this analysis are lower than the overall population due to missing data.
Alteration/impairment in sense of taste will be documented via questionnaire completion by participants administered via Qualtrics. Taste alteration/impairment will be measured on a 0-100 point scale "During the last three days, has your sense of taste been impaired or affected? Greatly Impaired/Affected 0 10 20 30 40 50 60 70 80 90 100 Not Impaired/Affected"
Outcome measures
| Measure |
Biotene Spray
n=96 Participants
Participants who received Biotene in either the first or last two week trial period of the study.
|
Refresh Spray
n=96 Participants
Participants who received Refresh spray in either the first or second two week period of the study.
|
|---|---|---|
|
Taste Alteration/Impairment Due to Oral Dryness
Taste baseline
|
73.2 units on a scale
Standard Deviation 29.0
|
71.5 units on a scale
Standard Deviation 29.3
|
|
Taste Alteration/Impairment Due to Oral Dryness
Taste 2 weeks
|
78.1 units on a scale
Standard Deviation 22.8
|
75.4 units on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: 2 week trialSwallowing and chewing difficulty due to oral dryness will be documented via questionnaire completion by participants administered via Qualtrics. Swallowing and chewing difficulty will be measured on a 0-100 point scale "During the last three days, overall, due to the dryness of your mouth and tongue, how difficult was it to chew and swallow food? Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy"
Outcome measures
| Measure |
Biotene Spray
n=96 Participants
Participants who received Biotene in either the first or last two week trial period of the study.
|
Refresh Spray
n=96 Participants
Participants who received Refresh spray in either the first or second two week period of the study.
|
|---|---|---|
|
Swallowing and Chewing Difficulty Due to Oral Dryness
swallowing baseline
|
53.7 units on a scale
Standard Deviation 25.6
|
54.6 units on a scale
Standard Deviation 24.4
|
|
Swallowing and Chewing Difficulty Due to Oral Dryness
swallowing 2 weeks
|
62.7 units on a scale
Standard Deviation 24.1
|
60.4 units on a scale
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 2 week trialPopulation: The number of participants in this analysis are lower than the overall population due to missing data.
PH Is a measure of acidity on a logarithmic scale range 0 (most acidic) to 14 (most basic) with a neutral PH of 7 as the desired outcome.
Outcome measures
| Measure |
Biotene Spray
n=96 Participants
Participants who received Biotene in either the first or last two week trial period of the study.
|
Refresh Spray
n=96 Participants
Participants who received Refresh spray in either the first or second two week period of the study.
|
|---|---|---|
|
Saliva PH
PH baseline
|
5.3 units on a scale
Standard Deviation 1.0
|
5.5 units on a scale
Standard Deviation 1.1
|
|
Saliva PH
PH 2 weeks
|
5.4 units on a scale
Standard Deviation 1.0
|
5.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: No participants in study with dental prosthesis, therefore data was not collected.
Difficulty wearing dental prostheses (if applicable) will be documented via questionnaire completion by participants administered via Qualtrics. Dental prostheses wearing difficulty will be measured on a 0-100 point scale "If you normally wear dentures, due to the dryness of your mouth and tongue, how difficult was it to wear dentures during the last three days? (If you do not normally wear dentures or could not wear dentures for other reasons not associated with dry mouth, please check the box marked "Not applicable") Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy Not Applicable
Outcome measures
Outcome data not reported
Adverse Events
Biotene Spray
Refresh Spray
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biotene Spray
n=129 participants at risk
Participants who received biotene spray in either the 1st or 2nd two week trial period
|
Refresh Spray
n=129 participants at risk
Participants who received Refresh spray in either the 1st or 2nd two week trial period
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
oral burning and swelling sensation
|
0.00%
0/129 • 6 weeks
|
3.9%
5/129 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place