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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT03003858
Eligibility Criteria:
Inclusion Criteria:
* Any gender and age between 6 and 16 years
* healthy condition and with a clinical diagnosis of mild to moderate gingivitis
* Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding)
* Plaque Index (PII) over then 7% (0= no plaque; 1= a film of plaque adhering to the free gingival margin, adjacent to the tooth; 2= moderate accumulation of soft deposits within the gingival pocket or between the tooth and gingival margin; 3= abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin)
* Bleeding on probing (BOP) over then 5%
Exclusion Criteria:
* taking antibiotics or anti-inflammatory drugs during or for 1 month prior to the study.
* any relevant systemic disease which is known to cause gingivitis
* history of any allergic reaction to HA
* to treat the gingivitis with any other medication/mouthwashes in the period of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT03003858
Study Brief:
Protocol Section:
NCT03003858