Status:
COMPLETED
Clinical Evaluation of Oral Rinse for Xerostomia
Lead Sponsor:
Sunstar Americas
Conditions:
Xerostomia
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04289051
Start Date
August 19 2020
End Date
February 4 2021
Last Update
February 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University at Buffalo, The Center for Dental Studies
Buffalo, New York, United States, 14214