Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT04289051
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04289051
Study Brief:
Protocol Section:
NCT04289051