Clinical Evaluation of Oral Rinse for Xerostomia

• Sponsor: Sunstar Americas (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04289051
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.6
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

Xerostomia causes a difficulty in eating, have irritated oral tissues, and a poor quality of life. The new oral rinse was designed to reduce the symptoms and improve the patient's quality of life. The objectives of the clinical study is to evaluate the effectiveness of the oral rinse comparing to the placebo product and the control product in the market.

This is a randomized double-blind placebo controlled crossover study with 39 patients receiving treatment. Patients will be randomly allocated to three treatment groups. Patients will use the assigned oral rinse four times a day for two weeks. Dry mouth symptoms and other endpoints will be assessed subjectively and objectively at baseline and Day 14. Patients will be assigned to another treatment after one week wash-out period.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia	Device: HYDRAL Oral Rinse; Device: BIOTENE® Oral Rinse; Device: Placebo Oral Rinse	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia
• Actual Study Start Date: Aug 19, 2020
• Actual Primary Completion Date: Feb 4, 2021
• Actual Study Completion Date: Feb 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HYDRAL Oral Rinse Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.	Device: HYDRAL Oral Rinse; Application 4 times a day for two weeks; Device: BIOTENE® Oral Rinse; Application 4 times a day for two weeks; Device: Placebo Oral Rinse; Application 4 times a day for two weeks
Active Comparator: BIOTENE® Oral Rinse Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.	Device: HYDRAL Oral Rinse; Application 4 times a day for two weeks; Device: BIOTENE® Oral Rinse; Application 4 times a day for two weeks; Device: Placebo Oral Rinse; Application 4 times a day for two weeks
Placebo Comparator: Placebo Oral Rinse Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.	Device: HYDRAL Oral Rinse; Application 4 times a day for two weeks; Device: BIOTENE® Oral Rinse; Application 4 times a day for two weeks; Device: Placebo Oral Rinse; Application 4 times a day for two weeks

Outcome Measures

Primary Outcome Measures

1. Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline [Baseline, 14 days]

   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.

2. Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline [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).

Secondary Outcome Measures

1. Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline [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).

2. Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Must have read, understood and signed an informed consent prior to being entered into the study.

2. Must be 18 to 80 years of age, male or female.

3. Have at least 20 natural or restored teeth.

4. Have an unstimulated salivary flow rate <0.20 ml/minute which represents a significant reduction of normal salivary function

5. Must have subjective xerostomia symptom: minimum level of 4 on a 10 centimeters Visual Analog Scale (VAS) [How would you score dryness of your mouth?]

6. Agree not to have a dental prophylaxis or any other elective, non-emergency dental procedures (other than those provided during the study) any time during the study.

7. Agree to abstain from the use of any products for xerostomia other than those provided in the study.

8. Agree to comply with the conditions and schedule of the study.

Exclusion Criteria:

1. Physical limitations or restrictions that might preclude normal tooth brushing.

2. Evidence of gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or soft or hard tissue tumor of the oral cavity.

3. Presence of severe gingivitis with 30 or more sites showing bleeding on probing.

4. Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.

5. Chronic disease with concomitant oral manifestations other than xerostomia

6. Conditions requiring antibiotic treatment prior to dental prophylaxis and invasive procedures, such as heart murmur, history of rheumatic fever, valvular disease or certain prosthetic implants.

7. History of hepatic or renal disease, uncontrolled diabetes, or other serious conditions or transmittable diseases.

8. Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months

9. Currently using bleaching trays

10. History of radiotherapy, head and neck cancer or Sjogren's syndrome.

11. History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.

12. Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study.

13. Currently breast feeding

14. Eating disorders

15. Recent history of substance abuse

16. Participation in other clinical studies within 14 days of screening

17. Smoking >10 cigarettes/day

18. Chewing tobacco

19. Daily use of symptom alleviating products against xerostomia within 7 days of screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University at Buffalo, The Center for Dental Studies	Buffalo	New York	United States	14214

Sponsors and Collaborators

• Sunstar Americas

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 13, 2020

More Information

Publications

None provided.

• Responsible Party: Sunstar Americas
• ClinicalTrials.gov Identifier: NCT04289051
• Other Study ID Numbers: CLP-2020-02-01-1
• First Posted: Feb 28, 2020
• Last Update Posted: Feb 24, 2022
• Last Verified: Dec 1, 2021

• 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
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Xerostomia

Study Results

Participant Flow

Arm/Group Title	HYDRAL Oral Rinse - Placebo Oral Rinse - Biotene Oral Rinse	Placebo Oral Rinse - Biotene Oral Rinse - HYDRAL Oral Rinse	BIOTENE Oral Rinse - HYDRAL Oral Rinse - Placebo Oral Rinse
Arm/Group Description	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	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	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
Period Title: Overall Study
STARTED	13	13	13
First Intervention (2 Weeks)	13	13	11
Washout (1 Week)	13	13	11
Second Intervention (2 Weeks)	13	13	11
Washout (1 Week)	13	13	11
Third Intervention (2 Weeks)	13	13	11
COMPLETED	13	13	11
NOT COMPLETED	0	0	2

Baseline Characteristics

Arm/Group Title	Overall Participants
Arm/Group Description	Subject disposition for all arms
Overall Participants	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.2 (12.6)
Sex: Female, Male (Count of Participants)
Female	23 59%
Male	16 41%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 2.6%
Asian	1 2.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 12.8%
White	30 76.9%
More than one race	0 0%
Unknown or Not Reported	2 5.1%
Region of Enrollment (participants) [Number]
United States	39 100%

Outcome Measures

1. Primary Outcome

Title	Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline
Description	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.
Time Frame	Baseline, 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HYDRAL Oral Rinse	Placebo Oral Rinse	BIOTENE® Oral Rinse
Arm/Group Description	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.	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.	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.
Measure Participants	37	37	37
Mean (Standard Deviation) [mm]	10.1 (2.5)	11.6 (3.9)	13.0 (3.2)

2. Primary Outcome

Title	Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline
Description	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).
Time Frame	Baseline, 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HYDRAL Oral Rinse	Placebo Oral Rinse	BIOTENE® Oral Rinse
Arm/Group Description	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.	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.	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.
Measure Participants	37	37	37
Mean (Standard Deviation) [Score on a scale]	1.0 (2.8)	0.4 (1.7)	0.5 (1.5)

3. Secondary Outcome

Title	Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline
Description	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).
Time Frame	Baseline, 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HYDRAL Oral Rinse	Placebo Oral Rinse	BIOTENE® Oral Rinse
Arm/Group Description	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.	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.	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.
Measure Participants	37	37	37
Mean (Standard Deviation) [Score on a scale]	2.0 (1.3)	0 (1.7)	1.2 (1.5)

4. Secondary Outcome

Title	Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline
Description	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.
Time Frame	Baseline, 14 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HYDRAL Oral Rinse	Placebo Oral Rinse	BIOTENE® Oral Rinse
Arm/Group Description	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.	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.	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.
Measure Participants	37	37	37
Mean (Standard Deviation) [mL/min]	0.08 (0.11)	0.00 (0.08)	0.05 (0.12)

Adverse Events

Time Frame	14 days
Arm/Group Title	HYDRAL Oral Rinse		Placebo Oral Rinse		BIOTENE® Oral Rinse
Arm/Group Description	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.		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.		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.
All Cause Mortality
	HYDRAL Oral Rinse		Placebo Oral Rinse		BIOTENE® Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/37 (0%)		0/37 (0%)
Serious Adverse Events
	HYDRAL Oral Rinse		Placebo Oral Rinse		BIOTENE® Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/37 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	HYDRAL Oral Rinse		Placebo Oral Rinse		BIOTENE® Oral Rinse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/37 (5.4%)		2/37 (5.4%)		6/37 (16.2%)
Gastrointestinal disorders
Oral mucosal irritation	1/37 (2.7%)	3	2/37 (5.4%)	4	5/37 (13.5%)	5
Infections and infestations
Urinary tract infection	1/37 (2.7%)	1	0/37 (0%)	0	0/37 (0%)	0
Respiratory, thoracic and mediastinal disorders
Sneezing	0/37 (0%)	0	0/37 (0%)	0	1/37 (2.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.