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Clinical Evaluation of Oral Rinse for Xerostomia

S

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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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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