<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03003858</url>
  </required_header>
  <id_info>
    <org_study_id>IDS DipCh 04</org_study_id>
    <nct_id>NCT03003858</nct_id>
  </id_info>
  <brief_title>Hyaluronic Acid and Gingivitis in Pediatrics</brief_title>
  <official_title>Retrospective Observational Trial on the Role of a Hyaluronic Acid Medical Device in Pediatric Patients Affected by Gingivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Opera CRO, a TIGERMED Group Company</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this observational, non-controlled, single site trial with a retrospective&#xD;
      design is to verify, in a large paediatric population affected by gingivitis, the&#xD;
      tolerability and safety of 0.1% HA-based film-forming devices (Gengigel Prof® Fluid,&#xD;
      Ricerfarma) administered three to five times a day over a 4-week period as an adjunct to&#xD;
      domiciliary care and oral hygiene instructions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy and safety data belonging to clinical trials with Hyaluronic Acid (HA) in oral&#xD;
      mucosa pathologies (gingivitis, post-surgical treatment of incisions of the buccal cavity,&#xD;
      periodontitis and other pathological periodontal conditions) have been confirmed in about 20&#xD;
      years of clinical practice by dentists. Starting from this experience, several clinical&#xD;
      centers, including our institute, have been introducing over the last years HAbased&#xD;
      film-forming devices in pediatrics. In particular, we have been using a liquid formulation&#xD;
      with 0.1% HA; it has been routinely administered in our clinic during the routine pre-visit&#xD;
      by Nurses and Dental Hygienist to children with gingivitis and given to the parents to&#xD;
      administered to the children in the post visit period as an adjunct to domiciliary care and&#xD;
      oral hygiene instructions. The product we used is featured by the following additional&#xD;
      characteristics:&#xD;
&#xD;
        -  a high concentration of HA, which explains its efficacy in reducing swelling and&#xD;
           secondary pain;&#xD;
&#xD;
        -  a liquid formulation, which can easily treat the whole gingival area, including the&#xD;
           points of more difficult access;&#xD;
&#xD;
        -  and at last, a really acceptable taste, that plays an interesting role to obtain a good&#xD;
           compliance from young patients.&#xD;
&#xD;
      The variables collected in this observational trial are the same collected during our current&#xD;
      clinical practice: Gingival Index (GI), Plaque Index (PII), Bleeding on probing (BOP), count&#xD;
      of edematous gingival sites and AE/SAE for safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>tolerability of 0.1% HA-based film-forming device</measure>
    <time_frame>4 week</time_frame>
    <description>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</description>
  </primary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Gingivitis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>0.1% HA-based film-forming device (Gengigel Prof® Fluid)</intervention_name>
    <description>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</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with a clinical diagnosis of mild to moderate gingivitis with at least 3 of the&#xD;
        following:&#xD;
&#xD;
          -  red, swollen, and spongy gums;&#xD;
&#xD;
          -  gums that bleed spontaneously or after brushing, eating or touching;&#xD;
&#xD;
          -  having bad breath;&#xD;
&#xD;
          -  sensation of tingling or itching of the gums;&#xD;
&#xD;
          -  presence of pus in the pockets between teeth.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any gender and age between 6 and 16 years&#xD;
&#xD;
          -  healthy condition and with a clinical diagnosis of mild to moderate gingivitis&#xD;
&#xD;
          -  Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight&#xD;
             change in color and slight edema but no bleeding on probing; 2= Moderate inflammation&#xD;
             - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked&#xD;
             redness and edema, ulceration with tendency to spontaneous bleeding)&#xD;
&#xD;
          -  Plaque Index (PII) over then 7% (0= no plaque; 1= a film of plaque adhering to the&#xD;
             free gingival margin, adjacent to the tooth; 2= moderate accumulation of soft deposits&#xD;
             within the gingival pocket or between the tooth and gingival margin; 3= abundance of&#xD;
             soft matter within the gingival pocket and/or on the tooth and gingival margin)&#xD;
&#xD;
          -  Bleeding on probing (BOP) over then 5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking antibiotics or anti-inflammatory drugs during or for 1 month prior to the&#xD;
             study.&#xD;
&#xD;
          -  any relevant systemic disease which is known to cause gingivitis&#xD;
&#xD;
          -  history of any allergic reaction to HA&#xD;
&#xD;
          -  to treat the gingivitis with any other medication/mouthwashes in the period of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianpietro Farronato, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dipartimento di Scienze Chirurgiche, Ricostruttive e Diagnostiche, IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, (Italy)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco Tremolati, Investigator</last_name>
    <role>Study Director</role>
    <affiliation>ASP Istituto Pio Albergo Trivulzio, Milano (Italy)</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gingivitis</keyword>
  <keyword>hyaluronic acid</keyword>
  <keyword>pediatrics</keyword>
  <keyword>medical devices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03003858
org study id: IDS DipCh 04
nct id: NCT03003858
lead sponsor: 
collaborator: 
has dmc: Yes
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
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.
observational model: Cohort
time perspective: Retrospective
measure: tolerability of 0.1% HA-based film-forming device
time frame: 4 week
description: 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
intervention type: Device
intervention name: 0.1% HA-based film-forming device (Gengigel Prof® Fluid)
description: 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
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: No
last name: Gianpietro Farronato, MD
role: Principal Investigator
affiliation: Dipartimento di Scienze Chirurgiche, Ricostruttive e Diagnostiche, IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, (Italy)
last name: Marco Tremolati, Investigator
role: Study Director
affiliation: ASP Istituto Pio Albergo Trivulzio, Milano (Italy)
responsible party type: Sponsor
mesh term: Gingivitis
sharing ipd: Yes