Tooth Disease Clinical Trial
Official title:
Performance and Tolerability of a New Medical Device Coating Gel for the Temporary Relief of Teething Symptoms: a Randomized, Open Label, Parallel-group, Multicentre Study
Verified date | May 2018 |
Source | Opera Contract Research Organization SRL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
Status | Completed |
Enrollment | 54 |
Est. completion date | June 30, 2015 |
Est. primary completion date | March 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 36 Months |
Eligibility |
Inclusion Criteria: 1. Male or female infants aged between 3 and 36 months. 2. Teething diagnosed by the presence of at least 3 of the following clinical symptoms: - pain - swelling - hyper-salivation - redness - abnormal teeth depth. 3. At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared. 4. Infants and parents who are in a general position to follow all study requirements. 5. Informed consent form signed by parents or legal representative. 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 oral Lidocaine, other topical oral anesthetic products 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 other anesthetics (except Dentinox®-Gel N, for subjects allocated to group II of treatment). 6. Subjects with known family history of allergic or adverse reactions to drugs or substances. 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Opera Contract Research Organization SRL |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in gingival swelling | Face, Legs, Activity, Cry and Consolability Pain Assesment Scale | 3 days | |
Secondary | changes in crying | Face, Legs, Activity, Cry and Consolability Pain Assesment Scale | 7 days |
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