Clinical Evaluation of Oral Rinse for Xerostomia

Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia

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.

Study Overview

• Status: Completed
• Conditions: Xerostomia
• Intervention / Treatment: Device: HYDRAL Oral Rinse; Device: BIOTENE® Oral Rinse; Device: Placebo Oral Rinse

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo, The Center for Dental Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dry Mouth Symptom by Visual Analog Scale at 14 Days From Baseline	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.	Baseline, 14 days
Change in Dry Mouth Symptoms by Xerostomia Questionnaire at 14 Days From Baseline	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).	Baseline, 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oral Functions by Revised Oral Assessment Guide at 14 Days From Baseline	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).	Baseline, 14 days
Change in Unstimulated Saliva Flow Rate at 14 Days From Baseline	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.	Baseline, 14 days

Collaborators and Investigators

• Sponsor: Sunstar Americas

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 19, 2020
• Primary Completion (ACTUAL): February 4, 2021
• Study Completion (ACTUAL): February 4, 2021

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: CLP-2020-02-01-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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