<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/NCT04438421</url>
  </required_header>
  <id_info>
    <org_study_id>BMG0703_ORC_May 2019 v.0</org_study_id>
    <nct_id>NCT04438421</nct_id>
  </id_info>
  <brief_title>Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment</brief_title>
  <official_title>Efficacy of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Inflammation and Bleeding Caused by Gingivitis, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Milan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen&#xD;
      Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications&#xD;
      associated gingivitis by film forming action.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque&#xD;
      and/or tartar selected consecutively. Subsequently, subjects will be equally divided and&#xD;
      randomized into the test group or control group.&#xD;
&#xD;
      During the three examinations, the subjects will undergo the collection of bleeding and&#xD;
      plaque indices according to Silness J &amp; Loe H 3,4. Four surfaces per tooth (vestibular,&#xD;
      lingual/palatal, mesial, distal) will be considered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>50 subjects affected with gingivitis, caused by accumulation of plaque and/or tartar, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated to either the test group or the control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bleeding index</measure>
    <time_frame>0, 3, 30 days</time_frame>
    <description>Subjects will undergo the measurement of bleeding index according to Silness J &amp; Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.&#xD;
Data will be collected based on four possible clinical conditions:&#xD;
Code 0: absence of bleeding during probing depth measurement; Code 1: absence of bleeding during probing depth measurement, presence of redness and oedema; Code 2: presence of bleeding during probing depth measurement with redness and oedema; Code 3: spontaneous bleeding&#xD;
Higher score means worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Plaque index</measure>
    <time_frame>0, 3, 30 days</time_frame>
    <description>Subjects will undergo the measurement of plaque index according to Silness J &amp; Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.&#xD;
Data will be collected based on four possible clinical conditions:&#xD;
Code 0: absence of plaque; Code 1: presence of plaque not visible to the naked eye but evidenced by the periodontal probe passage; Code 2: presence of plaque at the level of the gingival margin; Code 3: abundant presence of plaque at the level of the gingival margin and/or the rest of the dental surface.&#xD;
The sum of the values of the four surfaces examined, divided by the very number of surfaces, will give the plaque and bleeding index value for each individual tooth. The sum of the indices of each examined tooth divided by the total number of teeth examined will indicate the overall plaque and bleeding index of the subject at that time.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Gingivitis</condition>
  <condition>Bleeding Gum</condition>
  <arm_group>
    <arm_group_label>BMG0703</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine 0.2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will then be given a 0.2% Chlorhexidine product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will then be given a placebo product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid</intervention_name>
    <description>Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.</description>
    <arm_group_label>BMG0703</arm_group_label>
    <other_name>BMG0703</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine mouthwash</intervention_name>
    <description>Subjects will then be given Chlorhexidine 0.2%mouthwash, as an active comparator, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.</description>
    <arm_group_label>Chlorhexidine 0.2%</arm_group_label>
    <other_name>Chlorhexidine 0.2%</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will then be given a placebo product to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.</description>
    <arm_group_label>Placebo Product</arm_group_label>
    <other_name>Placebo product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged between 12 and 50 years&#xD;
&#xD;
          -  Presence of gingivitis caused by accumulation of plaque/tartar&#xD;
&#xD;
          -  Acceptance of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects suffering from HIV&#xD;
&#xD;
          -  subjects suffering from hepatitis&#xD;
&#xD;
          -  serious systemic diseases preventing the use of specific dental therapies&#xD;
&#xD;
          -  acute and/or chronic infectious diseases&#xD;
&#xD;
          -  inability to provide consent&#xD;
&#xD;
          -  use of topical or systemic drugs&#xD;
&#xD;
          -  inability to follow post-intervention hygiene instructions&#xD;
&#xD;
          -  smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giampietro Farronato, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Milan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gianguido Cossellu, Fellow</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Milan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chiara Occhipinti, Professor</last_name>
    <phone>+393339155689</phone>
    <email>Chiara.Occhipinti@unimi.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>UOC Maxillofacial Surgery and Odontology, University of Milan</name>
      <address>
        <city>Milan</city>
        <state>Lombardy</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.</citation>
    <PMID>15312097</PMID>
  </reference>
  <reference>
    <citation>SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.</citation>
    <PMID>14158464</PMID>
  </reference>
  <reference>
    <citation>Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.</citation>
    <PMID>5237684</PMID>
  </reference>
  <reference>
    <citation>Marchetti E, Tecco S, Caterini E, Casalena F, Quinzi V, Mattei A, Marzo G. Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial. Trials. 2017 Mar 31;18(1):154. doi: 10.1186/s13063-017-1901-z.</citation>
    <PMID>28359280</PMID>
  </reference>
  <reference>
    <citation>van der Weijden F, Slot DE. Oral hygiene in the prevention of periodontal diseases: the evidence. Periodontol 2000. 2011 Feb;55(1):104-23. doi: 10.1111/j.1600-0757.2009.00337.x. No abstract available.</citation>
    <PMID>21134231</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Milan</investigator_affiliation>
    <investigator_full_name>Chiara Occhipinti</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Gingivitis</keyword>
  <keyword>Bleeding</keyword>
  <keyword>Plaque</keyword>
  <keyword>Tartar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Hydrogen Peroxide</mesh_term>
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Protocol data available in PDF format upon request</ipd_description>
  </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/NCT04438421
org study id: BMG0703_ORC_May 2019 v.0
nct id: NCT04438421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen
      Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications
      associated gingivitis by film forming action.
50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque
      and/or tartar selected consecutively. Subsequently, subjects will be equally divided and
      randomized into the test group or control group.

      During the three examinations, the subjects will undergo the collection of bleeding and
      plaque indices according to Silness J & Loe H 3,4. Four surfaces per tooth (vestibular,
      lingual/palatal, mesial, distal) will be considered.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 50 subjects affected with gingivitis, caused by accumulation of plaque and/or tartar, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated to either the test group or the control group.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
measure: Change in Bleeding index
time frame: 0, 3, 30 days
description: Subjects will undergo the measurement of bleeding index according to Silness J & Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.
Data will be collected based on four possible clinical conditions:
Code 0: absence of bleeding during probing depth measurement; Code 1: absence of bleeding during probing depth measurement, presence of redness and oedema; Code 2: presence of bleeding during probing depth measurement with redness and oedema; Code 3: spontaneous bleeding
Higher score means worse outcome.
measure: Change in Plaque index
time frame: 0, 3, 30 days
description: Subjects will undergo the measurement of plaque index according to Silness J & Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.
Data will be collected based on four possible clinical conditions:
Code 0: absence of plaque; Code 1: presence of plaque not visible to the naked eye but evidenced by the periodontal probe passage; Code 2: presence of plaque at the level of the gingival margin; Code 3: abundant presence of plaque at the level of the gingival margin and/or the rest of the dental surface.
The sum of the values of the four surfaces examined, divided by the very number of surfaces, will give the plaque and bleeding index value for each individual tooth. The sum of the indices of each examined tooth divided by the total number of teeth examined will indicate the overall plaque and bleeding index of the subject at that time.
arm group label: BMG0703
arm group type: Experimental
description: Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
arm group label: Chlorhexidine 0.2%
arm group type: Active Comparator
description: Subjects will then be given a 0.2% Chlorhexidine product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.
arm group label: Placebo Product
arm group type: Placebo Comparator
description: Subjects will then be given a placebo product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month.
intervention type: Drug
intervention name: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid
description: Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
arm group label: BMG0703
other name: BMG0703
intervention type: Drug
intervention name: Chlorhexidine mouthwash
description: Subjects will then be given Chlorhexidine 0.2%mouthwash, as an active comparator, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
arm group label: Chlorhexidine 0.2%
other name: Chlorhexidine 0.2%
intervention type: Drug
intervention name: Placebo
description: Subjects will then be given a placebo product to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
arm group label: Placebo Product
other name: Placebo product
criteria: 
gender: All
minimum age: 12 Years
maximum age: 50 Years
healthy volunteers: No
last name: Giampietro Farronato, Professor
role: Principal Investigator
affiliation: University of Milan
last name: Gianguido Cossellu, Fellow
role: Principal Investigator
affiliation: University of Milan
last name: Chiara Occhipinti, Professor
phone: +393339155689
email: Chiara.Occhipinti@unimi.it
facility: 
country: Italy
citation: Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.
PMID: 15312097
citation: SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PMID: 14158464
citation: Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PMID: 5237684
citation: Marchetti E, Tecco S, Caterini E, Casalena F, Quinzi V, Mattei A, Marzo G. Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial. Trials. 2017 Mar 31;18(1):154. doi: 10.1186/s13063-017-1901-z.
PMID: 28359280
citation: van der Weijden F, Slot DE. Oral hygiene in the prevention of periodontal diseases: the evidence. Periodontol 2000. 2011 Feb;55(1):104-23. doi: 10.1111/j.1600-0757.2009.00337.x. No abstract available.
PMID: 21134231
responsible party type: Principal Investigator
investigator affiliation: University of Milan
investigator full name: Chiara Occhipinti
investigator title: Professor
mesh term: Gingivitis
mesh term: Hemorrhage
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Hydrogen Peroxide
mesh term: Hyaluronic Acid
sharing ipd: No
ipd description: Protocol data available in PDF format upon request