Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT03003858
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2016-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyaluronic Acid and Gingivitis in Pediatrics
Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Organization:
Study Overview
Official Title:
Retrospective Observational Trial on the Role of a Hyaluronic Acid Medical Device in Pediatric Patients Affected by Gingivitis
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this observational, non-controlled, single site trial with a retrospective design is to verify, in a large paediatric population affected by gingivitis, the tolerability and safety of 0.1% HA-based film-forming devices (Gengigel Prof® Fluid, Ricerfarma) administered three to five times a day over a 4-week period as an adjunct to domiciliary care and oral hygiene instructions
Detailed Description:
The efficacy and safety data belonging to clinical trials with Hyaluronic Acid (HA) in oral mucosa pathologies (gingivitis, post-surgical treatment of incisions of the buccal cavity, periodontitis and other pathological periodontal conditions) have been confirmed in about 20 years of clinical practice by dentists. Starting from this experience, several clinical centers, including our institute, have been introducing over the last years HAbased film-forming devices in pediatrics. In particular, we have been using a liquid formulation with 0.1% HA; it has been routinely administered in our clinic during the routine pre-visit by Nurses and Dental Hygienist to children with gingivitis and given to the parents to administered to the children in the post visit period as an adjunct to domiciliary care and oral hygiene instructions. The product we used is featured by the following additional characteristics:
* a high concentration of HA, which explains its efficacy in reducing swelling and secondary pain;
* a liquid formulation, which can easily treat the whole gingival area, including the points of more difficult access;
* and at last, a really acceptable taste, that plays an interesting role to obtain a good compliance from young patients.
The variables collected in this observational trial are the same collected during our current clinical practice: Gingival Index (GI), Plaque Index (PII), Bleeding on probing (BOP), count of edematous gingival sites and AE/SAE for safety.
* a high concentration of HA, which explains its efficacy in reducing swelling and secondary pain;
* a liquid formulation, which can easily treat the whole gingival area, including the points of more difficult access;
* and at last, a really acceptable taste, that plays an interesting role to obtain a good compliance from young patients.
The variables collected in this observational trial are the same collected during our current clinical practice: Gingival Index (GI), Plaque Index (PII), Bleeding on probing (BOP), count of edematous gingival sites and AE/SAE for safety.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: