Hyaluronic Acid and Gingivitis in Pediatrics
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Observational

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.
    

Intervention name(s): 0.1% HA-based film-forming device (Gengigel Prof® Fluid)
Intervention type(s): Device
Intervention description(s): 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
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children with a clinical diagnosis of mild to moderate gingivitis with at least 3 of the
        following:

          -  red, swollen, and spongy gums;

          -  gums that bleed spontaneously or after brushing, eating or touching;

          -  having bad breath;

          -  sensation of tingling or itching of the gums;

          -  presence of pus in the pockets between teeth.
      
Keywords: gingivitis; hyaluronic acid; pediatrics; medical devices