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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT01902095
Eligibility Criteria:
1. Inclusion Criteria
1. Male or female
2. Age ≥ 18-to-65 years (18th birthday completed)
3. In good general health
4. Available for the duration of the study
5. Able and willing to follow study protocol
6. Able and willing to sign approved informed consent
7. At least 20 natural teeth suitable for evaluation
8. Full mouth Gingival Index (GI) score ≥ 1.04
2. Exclusion Criteria
1. Females disagree to birth control measure for the duration of the study
2. Having any acute /chronic systemic illness
3. Current smokers or tobacco users
4. Pregnant or lactating Females
5. Allergy to the ingredients of the products to be tested
6. Requiring pre-medication prior to dental appointment
7. Antibiotic use in the last 3 months
8. Routine use of anticoagulant medication
9. Routine use of anti-inflammatory medication
10. Routine use of medications known to have effects on the gingiva e.g., phenytoin etc)
11. Routine use of medications inhibiting or stimulating salivary flow
12. Physical handicap that could interfere with daily performance of oral hygiene
13. Participation in any other study during the study period of this trial
14. Routine use of any mouthrinse
15. Routine use of any interdental cleaning device (floss, dental toothpicks)
16. Having any removable appliance
17. Having fixed orthodontic appliances (including permanent orthodontic retainers)
18. Having probing depth ≥4 mm at any site
19. Having had active periodontal therapy during the last 6 months
20. Had periodontal prophylaxis or periodontal maintenance therapy in the last 3 months
21. More than 3 carious lesions requiring immediate care
22. Gross oral pathology (e.g., tumors, candidiasis, mucocutaneous disease)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
33 Years
Maximum Age:
40 Years
Study:
NCT01902095
Study Brief:
Protocol Section:
NCT01902095