Status:
COMPLETED
CLINICAL EVALUATION OF THE EFFICACY OF AN INTRA ORAL SPRAY FOR PATIENTS WITH XEROSTOMIA
Lead Sponsor:
You First Services
Conditions:
Dry Mouth, Xerostomia.Hyaluronic Acid, Xylitol
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This cross-over group, double-blind, randomized, single center, study will enroll 26 subjects to target at least 24 subjects completing the study.Following an initial 3-5 minute evaluation of resting ...
Eligibility Criteria
Inclusion
- Have provided written informed consent prior to being entered into the study.
- Must be at least 18 years of age, male or female.
- Have at least 12 natural or restored teeth.
- Have a negative history of radiation therapy to head and neck
- Have a complaint of xerostomia
- Have an unstimulated salivary flow rate \<0.25ml/minute which represents 35-50% of normal salivary function
- 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 uncontrolled diabetes or hepatic or renal disease, or other serious conditions or transmittable diseases, (e.g. cardiovascular disease, AIDS).
- Subjects who are currently undergoing, or require, extensive dental work or orthodontic treatment.
- Currently using bleaching trays.
- History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth sprays.
- Subjects who are nursing, pregnant or plan to become pregnant for the duration of the study.
Key Trial Info
Start Date :
January 2 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04719091
Start Date
January 2 2016
End Date
February 29 2016
Last Update
January 22 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.