Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02931357
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2016-09-29
Brief Title:
Study of a New Medical Device in Gel Formulation Versus Calgel for the Topical Treatment of Teething in Infants
Sponsor:
Ricerfarma Srl
Organization:
Ricerfarma Srl
Study Overview
Official Title:
A Randomized Open Parallel-group Multicenter Study of Efficacy and Tolerability of a New Medical Device in Gel Formulation Hyaluronic Acid 054 Versus Calgel for the Topical Treatment of Teething in Infants
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized open label parallel-groups multicenter study The study will be conducted in three clinical sites Test Medical Device 054 Hyaluronic Acid rose honey flavour gel medical device class IIa
Detailed Description:
Due to the potentially serious toxicity that can result from the use of topical anesthetics to relieving the symptoms associated with gingival inflammatory conditions or gums trauma in infant recently products containing Hyaluronic Acid have been marketed in Europe In particular Ricerfarma is developing several high molecular weight Hyaluronic Acid medical devices characterized by the absence of preservatives alcohol and dyes therefore the administration of these products in infants is safe and can help creating a natural protective layer on the gingival tissue In previous clinical trials with these high molecular weight Hyaluronic Acid medical devices it was noted a periodontal tissuefluid balance with accelerated healing and repair properties that could be of interest either for accelerating the wound healing process or for treating the complex physical symptoms ie soreness and swelling of gums crying sleeplessness related to the teething in infants These data were confirmed by a recent pilot study on 18 infants suffering by teething where the two formulation of the tested high molecular weight Hyaluronic Acid medical device evidenced at the end of treatment period for pain swelling gingival rush hyper-salivation and redness a statistically significant reduction from baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None