Trial Outcomes & Findings for Clinical Evaluation of Oral Rinse for Xerostomia (NCT NCT04289051)

Last Updated: 2022-02-24

Results Overview

100 mm visual analog scale for subjective scoring the level of dry mouth (0 mm: not dry at all, 100 mm: very dry). Change in mm was calculated by subtracting the measurement at 14 days from the measurement at baseline. Higher values of the changes from baseline represent a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Baseline, 14 days

Results posted on

2022-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	HYDRAL Oral Rinse - Placebo Oral Rinse - Biotene Oral Rinse Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks. First intervention: HYDRAL Oral Rinse Second intervention: Placebo Oral Rinse Third intervention: BIOTENE® Oral Rinse	Placebo Oral Rinse - Biotene Oral Rinse - HYDRAL Oral Rinse Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of 2 weeks. First intervention: Placebo Oral Rinse Second intervention: BIOTENE® Oral Rinse Third intervention: HYDRAL Oral Rinse	BIOTENE Oral Rinse - HYDRAL Oral Rinse - Placebo Oral Rinse Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks. First intervention: BIOTENE® Oral Rinse Second intervention: HYDRAL Oral Rinse Third intervention: Placebo Oral Rinse
Overall Study STARTED	13	13	13
Overall Study First Intervention (2 Weeks)	13	13	11
Overall Study Washout (1 Week)	13	13	11
Overall Study Second Intervention (2 Weeks)	13	13	11
Overall Study Third Intervention (2 Weeks)	13	13	11
Overall Study COMPLETED	13	13	11
Overall Study NOT COMPLETED	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HYDRAL Oral Rinse - Placebo Oral Rinse - Biotene Oral Rinse Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks. First intervention: HYDRAL Oral Rinse Second intervention: Placebo Oral Rinse Third intervention: BIOTENE® Oral Rinse	Placebo Oral Rinse - Biotene Oral Rinse - HYDRAL Oral Rinse Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of 2 weeks. First intervention: Placebo Oral Rinse Second intervention: BIOTENE® Oral Rinse Third intervention: HYDRAL Oral Rinse	BIOTENE Oral Rinse - HYDRAL Oral Rinse - Placebo Oral Rinse Subjects use following oral rinses four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush. One-week washout period separates two different interventions of two weeks. First intervention: BIOTENE® Oral Rinse Second intervention: HYDRAL Oral Rinse Third intervention: Placebo Oral Rinse
Overall Study Lost to Follow-up	0	0	2

Baseline Characteristics

Clinical Evaluation of Oral Rinse for Xerostomia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=39 Participants Subject disposition for all arms
Age, Continuous	58.2 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 14 days

Outcome measures

Outcome measures
Measure	HYDRAL Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	Placebo Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	BIOTENE® Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline	10.1 mm Standard Deviation 2.5	11.6 mm Standard Deviation 3.9	13.0 mm Standard Deviation 3.2

PRIMARY outcome

Timeframe: Baseline, 14 days

Questionnaire to assess xerostomia symptoms. Subjects were asked the degree (grade 0: no problems to grade 3: the worst possible problem) of hoarse voice, oral dryness, oral pain, swallowing, and taste loss from which they were suffering in the xerostomia questionnaire. The symptoms scores were summed to calculate a total score per each subject (minimum total score: 0, maximum total score: 15). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -15, maximum change: 15).

Outcome measures

Outcome measures
Measure	HYDRAL Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	Placebo Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	BIOTENE® Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline	1.0 Score on a scale Standard Deviation 2.8	0.4 Score on a scale Standard Deviation 1.7	0.5 Score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline, 14 days

Assessment of oral functions by a dental professional. Eight categories were included in the assessment guide: voice, lips, mucous membranes, tongue, gums, teeth, saliva, and swallowing. Each category was described and rated from healthy (score 1) to severe (score 3). Scores for the categories were summed to calculate a total score per each subject (minimum total score: 8, maximum total score: 24). The change was calculated by subtracting the total score at 14 days from the total score at baseline. Higher values of the changes represent a better outcome (minimum change: -16, maximum change: 16).

Outcome measures

Outcome measures
Measure	HYDRAL Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	Placebo Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	BIOTENE® Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline	2.0 Score on a scale Standard Deviation 1.3	0 Score on a scale Standard Deviation 1.7	1.2 Score on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline, 14 days

Unstimulated whole saliva was collected over a 5-minute time period and the volume was measured. Change in mL per minute was calculated by subtracting the measurement at baseline from the measurement at 14 days.

Outcome measures

Outcome measures
Measure	HYDRAL Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	Placebo Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	BIOTENE® Oral Rinse n=37 Participants Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline	0.08 mL/min Standard Deviation 0.11	0.00 mL/min Standard Deviation 0.08	0.05 mL/min Standard Deviation 0.12

Adverse Events

HYDRAL Oral Rinse

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Oral Rinse

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

BIOTENE® Oral Rinse

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HYDRAL Oral Rinse n=37 participants at risk Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	Placebo Oral Rinse n=37 participants at risk Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.	BIOTENE® Oral Rinse n=37 participants at risk Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush for two weeks.
Gastrointestinal disorders Oral mucosal irritation	2.7% 1/37 • Number of events 3 • 14 days	5.4% 2/37 • Number of events 4 • 14 days	13.5% 5/37 • Number of events 5 • 14 days
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • 14 days	0.00% 0/37 • 14 days	0.00% 0/37 • 14 days
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/37 • 14 days	0.00% 0/37 • 14 days	2.7% 1/37 • Number of events 1 • 14 days

Additional Information

Akane Takemura

Sunstar Americas, Inc.

Phone: 18477944276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60