xml: <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/NCT05999175</url>
    </required_header>
    <id_info>
      <org_study_id>0002847/21</org_study_id>
      <nct_id>NCT05999175</nct_id>
    </id_info>
    <brief_title>Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash</brief_title>
    <official_title>Evaluation of the Tolerability, Safety of Use, and Efficacy of Cosmetic Products for the Oral Care. In Use Test Under Dentist Control</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biokosmes Srl</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Opera CRO, a TIGERMED Group Company</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Biokosmes Srl</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The purpose of this open-label, randomized controlled clinical trial, is to provide&#xD;
        preliminary clinical data (efficacy on plaque and gingival sensitivity, and safety and&#xD;
        tolerability of two types of toothpaste, a mouthwash, and a specifically custom-designed&#xD;
        toothbrush used for 28 days), as well as descriptive data on the effects of the products on&#xD;
        oral microbiota rebalancing and patient acceptability. Eighty-four participants with a&#xD;
        history of poor oral hygiene are visited at baseline and after 28 days of administration of&#xD;
        the tested products. The control group consisted of 12 participants who continued to use&#xD;
        their oral care products without changing their normal routine. At baseline and at the end of&#xD;
        treatment (final visit), the oral microbiome is also evaluated in a group of 12 subjects&#xD;
        allocated randomly.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A complete line of cosmetic products (Tau-marin Protezione e Prevenzione) was launched on the&#xD;
        Italian market in 2023. These products are based on an innovative formulation containing a&#xD;
        prebiotic (Bioecolia®) and a paraprobiotic based on Lactobacillus plantarum (SymrebootTM OC).&#xD;
        The products are the toothpastes &quot;Dentifricio Menta Delicata&quot; and &quot;Dentifricio Menta&quot; and the&#xD;
        mouthwash &quot;Collutorio Menta&quot;. The products should preferably be used with the &quot;Spazzolino&#xD;
        tau-marin&quot; toothbrush, which, thanks to the silver ions placed on the bristles, handle and&#xD;
        head of the toothbrush, can eliminate Staphylococcus aureus, methicillin-resistant&#xD;
        Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Escherichia coli bacteria.&#xD;
        Bioecolia® is an alpha-glucan oligosaccharide that is a preferred substrate for commensal&#xD;
        bacteria and selectively stimulates their growth. SymrebootTM OC belongs to the class of&#xD;
        paraprobiotics, i.e. non-viable microbial cells (either intact or disrupted) or crude cell&#xD;
        extracts, which, when administered in adequate amounts, provide a health benefit to the user.&#xD;
        SymrebootTM OC consists of heat treated Lactobacillus plantarum HEAL19. The combined action&#xD;
        of prebiotic and paraprobiotic results in the restoration of the symbiosis. Stability and&#xD;
        preclinical tests confirm the safety of these products for oral hygiene.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 17, 2022</start_date>
    <completion_date type="Actual">September 9, 2022</completion_date>
    <primary_completion_date type="Actual">July 26, 2022</primary_completion_date>
    <phase>N/A</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>Study participants would be randomly allocated to one of the following groups: Group 1 (20 subjects) would use the delicate mint toothpaste &quot;Dentifricio gel tau-marin® Menta Delicata&quot;; Group 2 (12 subjects) mint toothpaste &quot; Dentifricio gel tau-marin® Menta&quot;; Group 3 (20 subjects) mint mouthwash &quot;Collutorio tau-marin® Menta&quot;. Group 4 (20 subjects) would utilize delicate mint toothpaste &quot;Dentifricio gel tau-marin® Menta Delicata&quot; and mint mouthwash &quot; Collutorio tau-marin® Menta&quot;. These products would be applied with tau-marin® scalar toothbrush 33 medium with antibacterial &quot;Spazzolino tau-marin®&quot; three times a day after the main meals for 28 days. Group 5 (12 subjects) would continue to use routine oral hygiene products for 28 days. Groups 1 to 3 would be provided with a standard toothbrush (without any claims of efficacy) to be used three times a day after the main meals for 28 days.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gums sensitivity</measure>
      <time_frame>28 days</time_frame>
      <description>Change from baseline to day 14 and 28 days assessed by the Investigator during the dentist examination using a 10 cm visual analogue scale (VAS) where 0 is absence of sensitivity and 10 indicates the maximum of sensitivity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of gingival irritations</measure>
      <time_frame>28 days</time_frame>
      <description>Change from baseline to 14 and 28 days assessed by the Investigator during the dentist examination as follows: (Yes presence of gingival irritation; No = absence of gingival irritation).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of oral mucosa lesions</measure>
      <time_frame>28 days</time_frame>
      <description>Change from baseline to 14 and 28 days assessed by the Investigator during the dentist examination as follows: (Yes presence of oral mucosa lesion; No = absence of oral mucosa lesion).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dental plaque assessment</measure>
      <time_frame>1 day</time_frame>
      <description>Change from T0 (at the baseline at visit, performed three hours after the last teeth brushing) to Timm (evaluation done immediately after the first product use). The evaluation is carried out by means of an erythrosine-based disclosing tablet, which allows to quantify the presence of plaque on the teeth. First, the dentist gives the tablet to the subjects, who are asked to chew it thoroughly in their mouths. Then, the subjects are asked to rub the chewed particles of the tablets on their teeth with their tongue and swish the accumulated saliva in their mouth for about 60 seconds before rinsing with water. The releasing tablet stains the plaque on the teeth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Teeth colour assessment</measure>
      <time_frame>28 days</time_frame>
      <description>Change from baseline to 14 and 28 days as assessed by the investigator during the dentist's examination comparing the subjects' teeth with those shown on the VITAPAN® Score. The scoring system consists of a series of 16 &quot;artificial teeth&quot; in 16 different colors, each of which is associated with an alphanumeric code representing the entire chromatic space of natural teeth. It classifies tooth color into 4 families of shades as follows: reddish-brownish (A1, A2, A3, A3.5, A4), reddish-yellowish (B1, B2, B3, B4), grayish (C1, C2, C3, C4) and reddish-grey (D2, D3, D4).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-assessment questionnaire</measure>
      <time_frame>28 days</time_frame>
      <description>Subjects are asked to complete a self-report questionnaire on Timm (immediately after first use) and on days 14 and 28.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oral microbiota analysis</measure>
      <time_frame>28 days</time_frame>
      <description>It evaluates the change from baseline to 28 days. Oral microbiota is obtained by brushing a defined area of the mouth. Swabs are collected and stored at room temperature. Microbiome analysis is based on metagenomic analysis of the 16S rRNA gene.&#xD;
  The second step in the analysis pipeline is to isolate the bacterial DNA from other components of the sample. Through a series of cell lysis and extraction steps, the purified bacterial material is obtained. The bacterial material is then amplified by PCR, first to increase the amount of DNA, and second to label the genetic material - which will later allow identification of each sample during the sequencing step. The concentrations of the samples are equalized prior to pooling to create the sequencing mix. This solution is then loaded into a cartridge and analyzed by a sequencer. The biodiversity index (Shannon index) and statistics are calculated using a dedicated software (Microbiome analyst)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious Adverse Events/Adverse Events</measure>
      <time_frame>14 days</time_frame>
      <description>The number of participants with treatment-related adverse events will be assessed by CTCAE v6.0</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Actual">84</enrollment>
    <condition>Oral Hygiene</condition>
    <condition>Toothbrushing</condition>
    <condition>Dental Plaque</condition>
    <arm_group>
      <arm_group_label>Group 1 (20 subjects)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>using the delicate mint toothpaste &quot;Dentifricio gel tau-marin® Menta Delicata&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (12 subjects)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>using of the mint toothpaste &quot;Dentifricio gel tau-marin® Menta&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3 (20 subjects)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>using the mint mouthwash &quot;Collutorio tau-marin® Menta.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 4 (20 subjects)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>using the delicate mint toothpaste &quot;Dentifricio gel tau-marin® Menta Delicata&quot;, mint mouthwash &quot;Collutorio tau-marin® Menta&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 5 (12 subjects)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>continuing to use their routine oral hygiene products.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.</intervention_name>
      <description>the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.</description>
      <arm_group_label>Group 1 (20 subjects)</arm_group_label>
      <arm_group_label>Group 2 (12 subjects)</arm_group_label>
      <arm_group_label>Group 3 (20 subjects)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>the mint toothpaste and mouthwash are used with the scalar toothbrush 33 medium with antibacterial &quot; Spazzolino tau-marin®&quot; 3 times a day after the main meals for 28 days.</intervention_name>
      <description>the mint toothpaste and mouthwash are used with the scalar toothbrush 33 medium with antibacterial &quot; Spazzolino tau-marin®&quot; 3 times a day after the main meals for 28 days.</description>
      <arm_group_label>Group 4 (20 subjects)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>subjects of this group will use their routine oral hygiene products.</intervention_name>
      <description>subjects of this group will use their routine oral hygiene products.</description>
      <arm_group_label>Group 5 (12 subjects)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy Caucasian males and females aged ≥ 18 to ≤ 65 years included.&#xD;
  &#xD;
            -  Proper oral hygiene not performed verified with Simplified Oral Hygiene Index (OHI-S)&#xD;
               (score ≥ 2) and a questionnaire on oral habit.&#xD;
  &#xD;
            -  Patients able to comply with the requirements for the study and freely willing to&#xD;
               provide written informed consent to the collection of their data.&#xD;
  &#xD;
            -  Registered with Italian National Health Service (NHS).&#xD;
  &#xD;
            -  Ability to understand the language used in the investigation center and to comply with&#xD;
               the study procedures.&#xD;
  &#xD;
            -  Unbanned pharmacological therapy stable for at least one month without any changes&#xD;
               during the study.&#xD;
  &#xD;
            -  Commitment not to change the daily routine and lifestyle.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergies or sensitivity to oral care products, cosmetic products, drugs, patch or&#xD;
               medical devices.&#xD;
  &#xD;
            -  Any oral cavity condition inappropriate for participation.&#xD;
  &#xD;
            -  Gums bleeding due to pathologies/pharmacological treatment.&#xD;
  &#xD;
            -  Concomitant or during the last week antibiotic therapy.&#xD;
  &#xD;
            -  Smokers (≥5 cigarettes/day).&#xD;
  &#xD;
            -  Acute, chronic or progressive diseases/illness/conditions able to interfere with the&#xD;
               outcome of the study or considered dangerous or incompatible with the study&#xD;
               requirements.&#xD;
  &#xD;
            -  Pathological staining of teeth.&#xD;
  &#xD;
            -  Breast-feeding, pregnancy, or women of child-bearing age unwilling to take the&#xD;
               necessary precautions to avoid pregnancy during the study.&#xD;
  &#xD;
            -  Planning to participate or participation in other clinical trials withing 30 days.&#xD;
  &#xD;
            -  Hospitalization/planned hospitalization in a health or social facility.&#xD;
  &#xD;
            -  Deprivation of freedom by administrative or legal decision or under guardianship&#xD;
  &#xD;
            -  Inability to be contacted in case of emergency.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dario Cattaneo, DDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>San Genesio ed Uniti, Pavia (Italy)</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Studio D. Cattaneo</name>
        <address>
          <city>San Genesio ed Uniti</city>
          <state>Pavia</state>
          <zip>27010</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Complife Italia Srl</name>
        <address>
          <city>San Martino Siccomario</city>
          <state>Pavia</state>
          <zip>27028</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <link>
      <url>https://www.symrise.com/newsroom/article/symrise-launches-symrebootTM-oc-its-first-processed-probiotic-dedicated-to-oral-care/</url>
      <description>Related Info</description>
    </link>
    <reference>
      <citation>Willis JR, Gabaldon T. The Human Oral Microbiome in Health and Disease: From Sequences to Ecosystems. Microorganisms. 2020 Feb 23;8(2):308. doi: 10.3390/microorganisms8020308.</citation>
      <PMID>32102216</PMID>
    </reference>
    <reference>
      <citation>Abdulkareem AA, Al-Taweel FB, Al-Sharqi AJB, Gul SS, Sha A, Chapple ILC. Current concepts in the pathogenesis of periodontitis: from symbiosis to dysbiosis. J Oral Microbiol. 2023 Apr 2;15(1):2197779. doi: 10.1080/20002297.2023.2197779. eCollection 2023.</citation>
      <PMID>37025387</PMID>
    </reference>
    <reference>
      <citation>Kilian M, Chapple IL, Hannig M, Marsh PD, Meuric V, Pedersen AM, Tonetti MS, Wade WG, Zaura E. The oral microbiome - an update for oral healthcare professionals. Br Dent J. 2016 Nov 18;221(10):657-666. doi: 10.1038/sj.bdj.2016.865.</citation>
      <PMID>27857087</PMID>
    </reference>
    <reference>
      <citation>Rajendiran M, Trivedi HM, Chen D, Gajendrareddy P, Chen L. Recent Development of Active Ingredients in Mouthwashes and Toothpastes for Periodontal Diseases. Molecules. 2021 Apr 1;26(7):2001. doi: 10.3390/molecules26072001.</citation>
      <PMID>33916013</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gingival sensitivity</keyword>
    <keyword>manual toothbrush</keyword>
    <keyword>mouthwash</keyword>
    <keyword>oral hygiene</keyword>
    <keyword>oral microbiota stability</keyword>
    <keyword>oral mucosa</keyword>
    <keyword>plaque reduction</keyword>
    <keyword>toothbrush</keyword>
    <keyword>toothpaste</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Plaque</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Bacterial Agents</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999175
  org study id: 0002847/21
  nct id: NCT05999175
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this open-label, randomized controlled clinical trial, is to provide
        preliminary clinical data (efficacy on plaque and gingival sensitivity, and safety and
        tolerability of two types of toothpaste, a mouthwash, and a specifically custom-designed
        toothbrush used for 28 days), as well as descriptive data on the effects of the products on
        oral microbiota rebalancing and patient acceptability. Eighty-four participants with a
        history of poor oral hygiene are visited at baseline and after 28 days of administration of
        the tested products. The control group consisted of 12 participants who continued to use
        their oral care products without changing their normal routine. At baseline and at the end of
        treatment (final visit), the oral microbiome is also evaluated in a group of 12 subjects
        allocated randomly.
  A complete line of cosmetic products (Tau-marin Protezione e Prevenzione) was launched on the
        Italian market in 2023. These products are based on an innovative formulation containing a
        prebiotic (Bioecolia®) and a paraprobiotic based on Lactobacillus plantarum (SymrebootTM OC).
        The products are the toothpastes "Dentifricio Menta Delicata" and "Dentifricio Menta" and the
        mouthwash "Collutorio Menta". The products should preferably be used with the "Spazzolino
        tau-marin" toothbrush, which, thanks to the silver ions placed on the bristles, handle and
        head of the toothbrush, can eliminate Staphylococcus aureus, methicillin-resistant
        Staphylococcus aureus (MRSA), Pseudomonas aeruginosa and Escherichia coli bacteria.
        Bioecolia® is an alpha-glucan oligosaccharide that is a preferred substrate for commensal
        bacteria and selectively stimulates their growth. SymrebootTM OC belongs to the class of
        paraprobiotics, i.e. non-viable microbial cells (either intact or disrupted) or crude cell
        extracts, which, when administered in adequate amounts, provide a health benefit to the user.
        SymrebootTM OC consists of heat treated Lactobacillus plantarum HEAL19. The combined action
        of prebiotic and paraprobiotic results in the restoration of the symbiosis. Stability and
        preclinical tests confirm the safety of these products for oral hygiene.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Study participants would be randomly allocated to one of the following groups: Group 1 (20 subjects) would use the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata"; Group 2 (12 subjects) mint toothpaste " Dentifricio gel tau-marin® Menta"; Group 3 (20 subjects) mint mouthwash "Collutorio tau-marin® Menta". Group 4 (20 subjects) would utilize delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata" and mint mouthwash " Collutorio tau-marin® Menta". These products would be applied with tau-marin® scalar toothbrush 33 medium with antibacterial "Spazzolino tau-marin®" three times a day after the main meals for 28 days. Group 5 (12 subjects) would continue to use routine oral hygiene products for 28 days. Groups 1 to 3 would be provided with a standard toothbrush (without any claims of efficacy) to be used three times a day after the main meals for 28 days.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Gums sensitivity
  time frame: 28 days
  description: Change from baseline to day 14 and 28 days assessed by the Investigator during the dentist examination using a 10 cm visual analogue scale (VAS) where 0 is absence of sensitivity and 10 indicates the maximum of sensitivity.
  measure: Rate of gingival irritations
  time frame: 28 days
  description: Change from baseline to 14 and 28 days assessed by the Investigator during the dentist examination as follows: (Yes presence of gingival irritation; No = absence of gingival irritation).
  measure: Rate of oral mucosa lesions
  time frame: 28 days
  description: Change from baseline to 14 and 28 days assessed by the Investigator during the dentist examination as follows: (Yes presence of oral mucosa lesion; No = absence of oral mucosa lesion).
  measure: Dental plaque assessment
  time frame: 1 day
  description: Change from T0 (at the baseline at visit, performed three hours after the last teeth brushing) to Timm (evaluation done immediately after the first product use). The evaluation is carried out by means of an erythrosine-based disclosing tablet, which allows to quantify the presence of plaque on the teeth. First, the dentist gives the tablet to the subjects, who are asked to chew it thoroughly in their mouths. Then, the subjects are asked to rub the chewed particles of the tablets on their teeth with their tongue and swish the accumulated saliva in their mouth for about 60 seconds before rinsing with water. The releasing tablet stains the plaque on the teeth.
  measure: Teeth colour assessment
  time frame: 28 days
  description: Change from baseline to 14 and 28 days as assessed by the investigator during the dentist's examination comparing the subjects' teeth with those shown on the VITAPAN® Score. The scoring system consists of a series of 16 "artificial teeth" in 16 different colors, each of which is associated with an alphanumeric code representing the entire chromatic space of natural teeth. It classifies tooth color into 4 families of shades as follows: reddish-brownish (A1, A2, A3, A3.5, A4), reddish-yellowish (B1, B2, B3, B4), grayish (C1, C2, C3, C4) and reddish-grey (D2, D3, D4).
  measure: Self-assessment questionnaire
  time frame: 28 days
  description: Subjects are asked to complete a self-report questionnaire on Timm (immediately after first use) and on days 14 and 28.
  measure: Oral microbiota analysis
  time frame: 28 days
  description: It evaluates the change from baseline to 28 days. Oral microbiota is obtained by brushing a defined area of the mouth. Swabs are collected and stored at room temperature. Microbiome analysis is based on metagenomic analysis of the 16S rRNA gene.
  The second step in the analysis pipeline is to isolate the bacterial DNA from other components of the sample. Through a series of cell lysis and extraction steps, the purified bacterial material is obtained. The bacterial material is then amplified by PCR, first to increase the amount of DNA, and second to label the genetic material - which will later allow identification of each sample during the sequencing step. The concentrations of the samples are equalized prior to pooling to create the sequencing mix. This solution is then loaded into a cartridge and analyzed by a sequencer. The biodiversity index (Shannon index) and statistics are calculated using a dedicated software (Microbiome analyst)
  measure: Serious Adverse Events/Adverse Events
  time frame: 14 days
  description: The number of participants with treatment-related adverse events will be assessed by CTCAE v6.0
  arm group label: Group 1 (20 subjects)
  arm group type: Other
  description: using the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata".
  arm group label: Group 2 (12 subjects)
  arm group type: Other
  description: using of the mint toothpaste "Dentifricio gel tau-marin® Menta".
  arm group label: Group 3 (20 subjects)
  arm group type: Other
  description: using the mint mouthwash "Collutorio tau-marin® Menta.
  arm group label: Group 4 (20 subjects)
  arm group type: Other
  description: using the delicate mint toothpaste "Dentifricio gel tau-marin® Menta Delicata", mint mouthwash "Collutorio tau-marin® Menta".
  arm group label: Group 5 (12 subjects)
  arm group type: Other
  description: continuing to use their routine oral hygiene products.
  intervention type: Device
  intervention name: the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.
  description: the toothpaste is used with a standard toothbrush without any claims 3 times a day after the main meals for 28 days.
  arm group label: Group 1 (20 subjects)
  arm group label: Group 2 (12 subjects)
  arm group label: Group 3 (20 subjects)
  intervention type: Device
  intervention name: the mint toothpaste and mouthwash are used with the scalar toothbrush 33 medium with antibacterial " Spazzolino tau-marin®" 3 times a day after the main meals for 28 days.
  description: the mint toothpaste and mouthwash are used with the scalar toothbrush 33 medium with antibacterial " Spazzolino tau-marin®" 3 times a day after the main meals for 28 days.
  arm group label: Group 4 (20 subjects)
  intervention type: Device
  intervention name: subjects of this group will use their routine oral hygiene products.
  description: subjects of this group will use their routine oral hygiene products.
  arm group label: Group 5 (12 subjects)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dario Cattaneo, DDS
  role: Principal Investigator
  affiliation: San Genesio ed Uniti, Pavia (Italy)
  facility: 
  facility: 
  country: Italy
  url: https://www.symrise.com/newsroom/article/symrise-launches-symrebootTM-oc-its-first-processed-probiotic-dedicated-to-oral-care/
  description: Related Info
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  responsible party type: Sponsor
  mesh term: Dental Plaque
  mesh term: Anti-Bacterial Agents