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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT02931357
Eligibility Criteria:
Inclusion Criteria:
1. Male or female infants aged between 6 and 36 months.
2. Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
pain, swelling, gingival rush, hyper-salivation, redness, abnormal teeth depth.
3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
4. Informed consent form signed by parents or legal representative.
5. Infants and parents who are in a general position to follow all study requirements
Exclusion Criteria:
1. Infants in hospitalization and/or immobilization and/or confinement to bed.
2. Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems
3. Use of topical Lidocaine and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
4. Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
5. Concomitant use during the period of study of NSAIDs and/or any anesthetics (obviously Calgel® is allowed in patients randomized in group B, only)
6. Subjects with known history of allergic or adverse reactions to avian proteins or to HA and to any ingredient of the Medical Device and/or of the comparator on study.
7. Infants whose parents suffer from any form of psychiatric disorder or other condition which, in the opinion of the Investigator, might invalidate the required prescription and/or observation or complicate communication with the subject.
8. Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
9. Infants already treated under this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
36 Months
Study:
NCT02931357
Study Brief:
Protocol Section:
NCT02931357