Clinical Evaluation of Oral Rinse for Xerostomia

Sunstar

Status: Completed

Conditions: Xerostomia

Treatments: Device: BIOTENE® Oral Rinse; Device: HYDRAL Oral Rinse; Device: Placebo Oral Rinse

Study type: Interventional

Funder types: Industry

Identifiers

NCT04289051

CLP-2020-02-01-1

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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39 participants in 3 patient groups, including a placebo group

HYDRAL Oral Rinse

Experimental 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.

Treatment:

Device: BIOTENE® Oral Rinse

Device: Placebo Oral Rinse

Device: HYDRAL Oral Rinse

BIOTENE® Oral Rinse

Active Comparator 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.

Treatment:

Device: BIOTENE® Oral Rinse

Device: Placebo Oral Rinse

Device: HYDRAL Oral Rinse

Placebo Oral Rinse

Placebo Comparator 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.

Treatment:

Device: BIOTENE® Oral Rinse

Device: Placebo Oral Rinse

Device: HYDRAL Oral Rinse