Status:
COMPLETED
Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study
Lead Sponsor:
Opera CRO, a TIGERMED Group Company
Conditions:
Tooth Disease
Eligibility:
All Genders
3-36 years
Phase:
NA
Brief Summary
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
Detailed Description
Due to the potential toxicity that can result from the use of topical anesthetics to relieve the symptoms associated with gingival inflammatory conditions or gums trauma in infant, recently, products ...
Eligibility Criteria
Inclusion
- Male or female infants aged between 3 and 36 months.
- Teething diagnosed by the presence of at least 3 of the following clinical symptoms:
- pain
- swelling
- hyper-salivation
- redness
- abnormal teeth depth.
- At the moment of inclusion no subcutaneous mucosal laceration must be yet appeared.
- Infants and parents who are in a general position to follow all study requirements.
- Informed consent form signed by parents or legal representative.
Exclusion
- Infants in hospitalization and/or immobilization and/or confinement to bed.
- Infants with known history of severe renal insufficiency and/or known history of severe cardiac dysfunction and/or liver problems.
- Use of topical oral Lidocaine, other topical oral anesthetic products and/or topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within one day before inclusion.
- Use of systemic NSAIDs within 3 days before inclusion and/or use of systemic anesthetics within 10 days before.
- 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).
- Subjects with known family history of allergic or adverse reactions to drugs or substances.
- 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.
- Infants simultaneously participating or having participated in the last month before Visit 1 in another clinical trial.
Key Trial Info
Start Date :
November 15 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2015
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03423784
Start Date
November 15 2013
End Date
June 30 2015
Last Update
May 17 2018
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