Hyaluronic Acid and Gingivitis in Pediatrics

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)

Overall Status

Completed

CT.gov ID

NCT03003858

Collaborator

Opera CRO, a TIGERMED Group Company (Other)

200

Enrollment

Duration (Days)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Device: 0.1% HA-based film-forming device (Gengigel Prof® Fluid)

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.

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Outcome Measures

Primary Outcome Measures

tolerability of 0.1% HA-based film-forming device [4 week]
tolerability 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any gender and age between 6 and 16 years
healthy condition and with a clinical diagnosis of mild to moderate gingivitis
Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation
redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding)
Plaque Index (PII) over then 7% (0= no plaque; 1= a film of plaque adhering to the free gingival margin, adjacent to the tooth; 2= moderate accumulation of soft deposits within the gingival pocket or between the tooth and gingival margin; 3= abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin)
Bleeding on probing (BOP) over then 5%

Exclusion Criteria:

taking antibiotics or anti-inflammatory drugs during or for 1 month prior to the study.
any relevant systemic disease which is known to cause gingivitis
history of any allergic reaction to HA
to treat the gingivitis with any other medication/mouthwashes in the period of the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Opera CRO, a TIGERMED Group Company

Investigators

Principal Investigator: Gianpietro Farronato, MD, Dipartimento di Scienze Chirurgiche, Ricostruttive e Diagnostiche, IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, (Italy)
Study Director: Marco Tremolati, Investigator, ASP Istituto Pio Albergo Trivulzio, Milano (Italy)