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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04221334
Eligibility Criteria:
Inclusion Criteria:
1. • Male and female subjects had to be between the ages of 18 and 70 (inclusive),
2. • Subjects needed to be available for the duration (6 weeks) of the study,
3. • Subjects had to possess minimum of 20 uncrowned permanent natural teeth (excluding third molars),
4. • Subjects were required to present and an initial mean gingivitis score of at least 1.0 as determined by the use of the Löe-Silness Gingival Index,
5. • Subjects were required to present an initial mean plaque index of at least 0.6 as determined by the use of the Rustogi Modification of the Navy Plaque Index,
6. • Subjects had to sign an Informed Consent form,
7. • Subjects had to be in general good health and
8. • Subjects with no known history of allergies to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring of the study.
Exclusion:
1. • Medical condition which require pre-medication prior to dental visits/procedures,
2. • The presence of partial removable dentures,
3. • Subjects who had advanced periodontal disease (gum disease),
4. • Five (5) or more decayed or untreated dental sites at screening (cavities),
5. • Subjects with diseases of the soft or hard oral tissues,
6. • Subjects with orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring),
7. • Dry mouth as a result of a medication or medical condition,
8. • Use of drugs that can currently affect salivary flow,
9. • Use of antibiotics one (1) month prior to or during this study,
10. • Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion,
11. • Chronic (\>3 3 times/week) use of medications that are known to affect gingival tissues including steroids or non-steroidal anti-inflammatory medications or the listed medications (phenytoin, calcium antagonists, Coumadin, cyclosporine),
12. • Any diseases that might affect the assessment of the study treatment or gingival tissues (rheumatoid arthritis, Crohn's disease, diabetes), ongoing chemotherapy for cancer, radiation therapy for head and neck cancer,
13. • Pregnant or breast-feeding women were excluded from the study,
14. • Subjects who participated in any other clinical study in the month preceding this study,
15. • Allergic to common dentifrice ingredients,
16. • Medical condition which prohibits not eating/drinking or chewing gum for 4 hours prior to their scheduled visit,
17. • Immune compromised individuals (AIDS, immune suppressive drug therapy) and
18. • History of infectious disease or other blood borne diseases (Hepatitis series, HIV).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04221334
Study Brief:
Protocol Section:
NCT04221334