Back to resultsClinical Evaluation of Oral Rinse for Xerostomia
Primary Purpose
Xerostomia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HYDRAL Oral Rinse
BIOTENE® Oral Rinse
Placebo Oral Rinse
Sponsored by
About this trial
This is an interventional treatment trial for Xerostomia
Eligibility Criteria
Inclusion Criteria:
- Must have read, understood and signed an informed consent prior to being entered into the study.
- Must be 18 to 80 years of age, male or female.
- Have at least 20 natural or restored teeth.
- Have an unstimulated salivary flow rate <0.20 ml/minute which represents a significant reduction of normal salivary function
- 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?]
- 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.
- Agree to abstain from the use of any products for xerostomia other than those provided in the study.
- Agree to comply with the conditions and schedule of the study.
Exclusion Criteria:
- Physical limitations or restrictions that might preclude normal tooth brushing.
- 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.
- Presence of severe gingivitis with 30 or more sites showing bleeding on probing.
- Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
- Chronic disease with concomitant oral manifestations other than xerostomia
- 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.
- History of hepatic or renal disease, uncontrolled diabetes, or other serious conditions or transmittable diseases.
- Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
- Currently using bleaching trays
- History of radiotherapy, head and neck cancer or Sjogren's syndrome.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
- Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study.
- Currently breast feeding
- Eating disorders
- Recent history of substance abuse
- Participation in other clinical studies within 14 days of screening
- Smoking >10 cigarettes/day
- Chewing tobacco
- Daily use of symptom alleviating products against xerostomia within 7 days of screening.
Sites / Locations
- University at Buffalo, The Center for Dental Studies
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
HYDRAL Oral Rinse
BIOTENE® Oral Rinse
Placebo Oral Rinse
Arm 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.
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Subjects use the oral rinse four times daily adding to a regular oral hygiene routine with a fluoride toothpaste and a soft tooth brush.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04289051
Brief Title
Clinical Evaluation of Oral Rinse for Xerostomia
Official Title
Clinical Evaluation of the Efficacy of an Intra Oral Rinse for Patients With Xerostomia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
February 4, 2021 (Actual)
Study Completion Date
February 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Xerostomia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HYDRAL Oral Rinse
Arm Type
Experimental
Arm 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.
Arm Title
BIOTENE® Oral Rinse
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo Oral Rinse
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
HYDRAL Oral Rinse
Intervention Description
Application 4 times a day for two weeks
Intervention Type
Device
Intervention Name(s)
BIOTENE® Oral Rinse
Intervention Description
Application 4 times a day for two weeks
Intervention Type
Device
Intervention Name(s)
Placebo Oral Rinse
Intervention Description
Application 4 times a day for two weeks
Primary Outcome Measure Information:
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
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
Secondary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have read, understood and signed an informed consent prior to being entered into the study.
Must be 18 to 80 years of age, male or female.
Have at least 20 natural or restored teeth.
Have an unstimulated salivary flow rate <0.20 ml/minute which represents a significant reduction of normal salivary function
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?]
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.
Agree to abstain from the use of any products for xerostomia other than those provided in the study.
Agree to comply with the conditions and schedule of the study.
Exclusion Criteria:
Physical limitations or restrictions that might preclude normal tooth brushing.
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.
Presence of severe gingivitis with 30 or more sites showing bleeding on probing.
Evidence of major oral hard or soft tissue lesions or trauma at the baseline visit as determined by the Investigator/Examiner.
Chronic disease with concomitant oral manifestations other than xerostomia
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.
History of hepatic or renal disease, uncontrolled diabetes, or other serious conditions or transmittable diseases.
Subjects who are currently undergoing, or require, extensive dental work, orthodontic treatment or periodontal surgery or orthodontic treatment in the preceding 3 months
Currently using bleaching trays
History of radiotherapy, head and neck cancer or Sjogren's syndrome.
History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses.
Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study.
Currently breast feeding
Eating disorders
Recent history of substance abuse
Participation in other clinical studies within 14 days of screening
Smoking >10 cigarettes/day
Chewing tobacco
Daily use of symptom alleviating products against xerostomia within 7 days of screening.
Facility Information:
Facility Name
University at Buffalo, The Center for Dental Studies
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Oral Rinse for Xerostomia
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