<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/NCT04446533</url>
  </required_header>
  <id_info>
    <org_study_id>Orto_BMG0703_PRD_June_2020</org_study_id>
    <nct_id>NCT04446533</nct_id>
  </id_info>
  <brief_title>Effect of a Hydrogen-Peroxide and Hyaluronic-Acid Mouthwash (BMG0703) in the Treatment of Periodontitis</brief_title>
  <official_title>Assessment of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Periodontitis, 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>
    <collaborator>
      <agency>BMG Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      Assessment of the efficacy of BMG0703 in the treatment of periodontitis and control of&#xD;
      supragingival plaque, compared to Chlorhexidine and a placebo product&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The enrolled subjects will be examined and treated by specialized medical personnel.&#xD;
&#xD;
      Patients will undergo a professional oral hygiene session (causal therapy) and will be&#xD;
      instructed to perform proper oral hygiene manoeuvres at home.&#xD;
&#xD;
      Next, subjects will be divided into three groups: after the causal therapy, the treatment of&#xD;
      the pockets will be performed by probing, between 3 and 7 mm, with the test product, active&#xD;
      comparator or placebo, with the aid of a dedicated sterile syringe. The application will be&#xD;
      repeated after approx. 5 minutes.&#xD;
&#xD;
      One bottle of the product (test, comparative or placebo) will then be given to the patient&#xD;
      who will be instructed to use it 3 times a day, after meals and after normal oral hygiene&#xD;
      procedures, for at least one week.&#xD;
&#xD;
      The subjects will then be re-evaluated after 3 days and after a week. During these check-ups,&#xD;
      new samples will be collected at the level of the initial sampling sites and will be&#xD;
      reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and&#xD;
      probing depth).&#xD;
&#xD;
      Patients with allergic reactions or hypersensitivity due to the use of the products will be&#xD;
      advised to discontinue the use of the products and seek medical advice.&#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>Following a professional oral hygiene session, subjects will be divided into three groups: BMG0703, active comparator a nd placebo.&#xD;
First application of products will be applied clinically, and subsequently, one bottle of the product (test, comparative or placebo) will be given to the patient to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</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 either by the operator or 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 on the basis of 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.&#xD;
The data will be collected in pseudonymised form and inserted into a dedicated database in order to carry out the statistical analysis provided.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bleeding index</measure>
    <time_frame>0, 3, 7, 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, 7, 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;
Higher score means worse outcome&#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>
  <secondary_outcome>
    <measure>Change in Microbiological analysis</measure>
    <time_frame>0,3,7,30 days</time_frame>
    <description>The DNA-Sorb-B (Sacace) nucleic acid extraction kit will be used for the extraction and purification of bacterial DNA from clinical samples. Bacterial genome extraction is performed on 500 microlitres of oral sample fluid obtained from each patient.&#xD;
The molecular analysis, using Real Time PCR, involves the use of the KIT Periodontitis (PeriodontScreen Real-TM, Sacace), and in particular the following bacterial species will be researched: Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Tannerella forsythia, Porphyromonas endodontalis.&#xD;
Periodontopathogenic bacteria are divided into high (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticle, Tannerella forsythia) and medium risk (Fusobacterium nucleatum, Prevotella Intermediate, Porphyromonas endodontalis). The results of the molecular analysis will be related to the clinical indices obtained from each patient.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Periodontitis</condition>
  <condition>Bleeding Gum</condition>
  <condition>Pocket, Periodontal</condition>
  <arm_group>
    <arm_group_label>Hydrogen Peroxide and Hyaluronic acid (BMG0703)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.&#xD;
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.&#xD;
One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine 0.2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.&#xD;
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.&#xD;
One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo product</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.&#xD;
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.&#xD;
One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrogen Peroxide and Hyaluronic acid filming formulation</intervention_name>
    <description>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.&#xD;
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.&#xD;
One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</description>
    <arm_group_label>Hydrogen Peroxide and Hyaluronic acid (BMG0703)</arm_group_label>
    <other_name>BMG0703</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine 0.2%</intervention_name>
    <description>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.&#xD;
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.&#xD;
One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</description>
    <arm_group_label>Chlorhexidine 0.2%</arm_group_label>
    <other_name>Chlorhexidine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.&#xD;
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.&#xD;
One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.&#xD;
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).</description>
    <arm_group_label>Placebo product</arm_group_label>
    <other_name>Placebo product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of periodontitis with pockets between 3 and 7 mm&#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 pathologies&#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>18 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>Caton J, Greenstein G, Polson AM. Depth of periodontal probe penetration related to clinical and histologic signs of gingival inflammation. J Periodontol. 1981 Oct;52(10):626-9. doi: 10.1902/jop.1981.52.10.626.</citation>
    <PMID>6975365</PMID>
  </reference>
  <reference>
    <citation>Fowler C, Garrett S, Crigger M, Egelberg J. Histologic probe position in treated and untreated human periodontal tissues. J Clin Periodontol. 1982 Sep;9(5):373-85. doi: 10.1111/j.1600-051x.1982.tb02048.x.</citation>
    <PMID>6754765</PMID>
  </reference>
  <reference>
    <citation>Polson AM, Caton JG, Yeaple RN, Zander HA. Histological determination of probe tip penetration into gingival sulcus of humans using an electronic pressure-sensitive probe. J Clin Periodontol. 1980 Dec;7(6):479-88. doi: 10.1111/j.1600-051x.1980.tb02154.x.</citation>
    <PMID>6938528</PMID>
  </reference>
  <reference>
    <citation>Keagle JG, Garnick JJ, Searle JR, King GE, Morse PK. Gingival resistance to probing forces. I. Determination of optimal probe diameter. J Periodontol. 1989 Apr;60(4):167-71. doi: 10.1902/jop.1989.60.4.167.</citation>
    <PMID>2724029</PMID>
  </reference>
  <reference>
    <citation>Hull PS, Clerehugh V, Ghassemi-Aval A. An assessment of the validity of a constant force electronic probe in measuring probing depths. J Periodontol. 1995 Oct;66(10):848-51. doi: 10.1902/jop.1995.66.10.848.</citation>
    <PMID>8537866</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 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>Periodontitis</keyword>
  <keyword>Bleeding Gum</keyword>
  <keyword>Periodontal Pocket</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Gingival Hemorrhage</mesh_term>
    <mesh_term>Periodontal Pocket</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>Data available 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/NCT04446533
org study id: Orto_BMG0703_PRD_June_2020
nct id: NCT04446533
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Assessment of the efficacy of BMG0703 in the treatment of periodontitis and control of
      supragingival plaque, compared to Chlorhexidine and a placebo product
The enrolled subjects will be examined and treated by specialized medical personnel.

      Patients will undergo a professional oral hygiene session (causal therapy) and will be
      instructed to perform proper oral hygiene manoeuvres at home.

      Next, subjects will be divided into three groups: after the causal therapy, the treatment of
      the pockets will be performed by probing, between 3 and 7 mm, with the test product, active
      comparator or placebo, with the aid of a dedicated sterile syringe. The application will be
      repeated after approx. 5 minutes.

      One bottle of the product (test, comparative or placebo) will then be given to the patient
      who will be instructed to use it 3 times a day, after meals and after normal oral hygiene
      procedures, for at least one week.

      The subjects will then be re-evaluated after 3 days and after a week. During these check-ups,
      new samples will be collected at the level of the initial sampling sites and will be
      reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and
      probing depth).

      Patients with allergic reactions or hypersensitivity due to the use of the products will be
      advised to discontinue the use of the products and seek medical advice.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Following a professional oral hygiene session, subjects will be divided into three groups: BMG0703, active comparator a nd placebo.
First application of products will be applied clinically, and subsequently, one bottle of the product (test, comparative or placebo) will be given to the patient to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The products will be packaged in such a way that they are not recognizable either by the operator or 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 on the basis of 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.
The data will be collected in pseudonymised form and inserted into a dedicated database in order to carry out the statistical analysis provided.
measure: Change in Bleeding index
time frame: 0, 3, 7, 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, 7, 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.
Higher score means worse outcome
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.
measure: Change in Microbiological analysis
time frame: 0,3,7,30 days
description: The DNA-Sorb-B (Sacace) nucleic acid extraction kit will be used for the extraction and purification of bacterial DNA from clinical samples. Bacterial genome extraction is performed on 500 microlitres of oral sample fluid obtained from each patient.
The molecular analysis, using Real Time PCR, involves the use of the KIT Periodontitis (PeriodontScreen Real-TM, Sacace), and in particular the following bacterial species will be researched: Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Tannerella forsythia, Porphyromonas endodontalis.
Periodontopathogenic bacteria are divided into high (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticle, Tannerella forsythia) and medium risk (Fusobacterium nucleatum, Prevotella Intermediate, Porphyromonas endodontalis). The results of the molecular analysis will be related to the clinical indices obtained from each patient.
arm group label: Hydrogen Peroxide and Hyaluronic acid (BMG0703)
arm group type: Experimental
description: Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
arm group label: Chlorhexidine 0.2%
arm group type: Active Comparator
description: Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
arm group label: Placebo product
arm group type: Placebo Comparator
description: Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
intervention type: Drug
intervention name: Hydrogen Peroxide and Hyaluronic acid filming formulation
description: Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
arm group label: Hydrogen Peroxide and Hyaluronic acid (BMG0703)
other name: BMG0703
intervention type: Drug
intervention name: Chlorhexidine 0.2%
description: Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
arm group label: Chlorhexidine 0.2%
other name: Chlorhexidine
intervention type: Drug
intervention name: Placebo
description: Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
arm group label: Placebo product
other name: Placebo product
criteria: 
gender: All
minimum age: 18 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: Caton J, Greenstein G, Polson AM. Depth of periodontal probe penetration related to clinical and histologic signs of gingival inflammation. J Periodontol. 1981 Oct;52(10):626-9. doi: 10.1902/jop.1981.52.10.626.
PMID: 6975365
citation: Fowler C, Garrett S, Crigger M, Egelberg J. Histologic probe position in treated and untreated human periodontal tissues. J Clin Periodontol. 1982 Sep;9(5):373-85. doi: 10.1111/j.1600-051x.1982.tb02048.x.
PMID: 6754765
citation: Polson AM, Caton JG, Yeaple RN, Zander HA. Histological determination of probe tip penetration into gingival sulcus of humans using an electronic pressure-sensitive probe. J Clin Periodontol. 1980 Dec;7(6):479-88. doi: 10.1111/j.1600-051x.1980.tb02154.x.
PMID: 6938528
citation: Keagle JG, Garnick JJ, Searle JR, King GE, Morse PK. Gingival resistance to probing forces. I. Determination of optimal probe diameter. J Periodontol. 1989 Apr;60(4):167-71. doi: 10.1902/jop.1989.60.4.167.
PMID: 2724029
citation: Hull PS, Clerehugh V, Ghassemi-Aval A. An assessment of the validity of a constant force electronic probe in measuring probing depths. J Periodontol. 1995 Oct;66(10):848-51. doi: 10.1902/jop.1995.66.10.848.
PMID: 8537866
responsible party type: Principal Investigator
investigator affiliation: University of Milan
investigator full name: Chiara Occhipinti
investigator title: Professor
mesh term: Periodontitis
mesh term: Gingival Hemorrhage
mesh term: Periodontal Pocket
mesh term: Hemorrhage
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Hydrogen Peroxide
mesh term: Hyaluronic Acid
sharing ipd: No
ipd description: Data available upon request