Clinical Evaluation of Oral Rinse for Xerostomia

Study Overview
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Brief Summary
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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.

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

Conditions
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Xerostomia

Intervention / Treatment
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* Device: HYDRAL Oral Rinse
* Device: BIOTENE® Oral Rinse
* Device: Placebo Oral Rinse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYDRAL Oral Rinse<br>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<br>* Application 4 times a day for two weeks<br>Device: BIOTENE® Oral Rinse<br>* Application 4 times a day for two weeks<br>Device: Placebo Oral Rinse<br>* Application 4 times a day for two weeks<br>|
| Active Comparator: BIOTENE® Oral Rinse<br>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<br>* Application 4 times a day for two weeks<br>Device: BIOTENE® Oral Rinse<br>* Application 4 times a day for two weeks<br>Device: Placebo Oral Rinse<br>* Application 4 times a day for two weeks<br>|
| Placebo Comparator: Placebo Oral Rinse<br>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<br>* Application 4 times a day for two weeks<br>Device: BIOTENE® Oral Rinse<br>* Application 4 times a day for two weeks<br>Device: Placebo Oral Rinse<br>* Application 4 times a day for two weeks<br>|

What is the study measuring?
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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 |