NCT03003858

Hyaluronic Acid and Gingivitis in Pediatrics

Retrospective Observational Trial on the Role of a Hyaluronic Acid Medical Device in Pediatric Patients Affected by Gingivitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DEVICE	0.1% HA-based film-forming device (Gengigel Prof® Fluid)	0.1% HA-based film-forming device (Gengigel Prof® Fluid, Ricerfarma, Milano, Italy) administered (oral rinses for 3-5 min.) three to five times a day over a 4-week period as an adjunct to domiciliary care and oral hygiene instructions and motivation

Timeline

• Start date: 2016-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-12-28
• Last updated: 2017-01-10