<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/NCT04430998</url>
  </required_header>
  <id_info>
    <org_study_id>COCMFFP-M-01-2020</org_study_id>
    <nct_id>NCT04430998</nct_id>
  </id_info>
  <brief_title>Efficacy of Zinc L-Carnosine Mouth Rinse</brief_title>
  <official_title>Efficacy of a Zinc-L-Carnosine -Based Mouth Rinse on Periodontal Tissues and Pain After Scaling and Root Planing - a Randomized Clinical Trial; a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Azienda Farmaceutica Italiana SRL</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal&#xD;
      tissues and pain after scaling and root planing&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double blind, 3 group parallel study with random allocation of 75 patients to&#xD;
      any of three groups; Zinc-L-Carnosine-based mouth rinse, Chlorhexidine mouth rinse and&#xD;
      placebo (water) control. Three days after professional oral hygiene, which aimed at the&#xD;
      normalization of the periodontal index, the primary (HI, VAS) and secondary (mSBI; FMPS; VMI;&#xD;
      SI) outcomes of the study are measured to obtain baseline information, and then scaling and&#xD;
      root planing are carried out.&#xD;
&#xD;
      The participants will be advised to follow their regular oral hygiene procedures (tooth&#xD;
      brushing) in addition to the allocated mouth rinse. They will be examined again for primary&#xD;
      and secondary outcomes at 7 and 21 days.&#xD;
&#xD;
      Clinical evaluation:&#xD;
&#xD;
      Clinical examination of each participant will be done by a single examiner using the&#xD;
      previously described VAS scale and a UNC periodontal probe (No. 5 explorer Hu-Friedy,&#xD;
      Chicago, Ill). In addition to these indices, each subject will be asked to report any adverse&#xD;
      events they have encountered during the experiment.&#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">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 22, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Healing Index (H.I.)</measure>
    <time_frame>0, 7, 21 days</time_frame>
    <description>The Laundry-Turnbull and Howley index will be used to evaluate healing, considering the changes made by Pippi et al. In 2015. In particular, seven parameters will be assessed, to each of which a value of 1 or 0 will be assigned. The sum of the values will indicate the degree of healing to be compared between the different groups.&#xD;
These seven parameters are: redness of mucosa, granulation tissue, suppuration, swelling, re-epithelialization, bleeding, pain on palpation.&#xD;
Higher score means worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Visual Analogue Scale (VAS) of pain</measure>
    <time_frame>0, 7, 21 days</time_frame>
    <description>Participants will be asked to mark the perceived degree of pain on a scale of 100 dashes, with the lowest score being &quot;no pain&quot; and the highest &quot;the worst pain&quot;.&#xD;
Higher score means worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Modified Sulcus Bleeding index (Mombelli) (mSBI)</measure>
    <time_frame>0, 7, 21 days</time_frame>
    <description>The clinical examination of each participant will be carried out by a single examiner using the UNC periodontal probe and the explorer n. 5 (Hu-Friedy, Chicago, III) to assess sulcus bleeding and assign a score: 0 absence of bleeding;&#xD;
presence of bleeding on probing without redness and edema;&#xD;
presence of bleeding on probing with redness and edema;&#xD;
spontaneous bleeding.&#xD;
6 sites (3 buccal + 3 lingual / palatal) are considered for each tooth.&#xD;
Higher score means worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Full Mouth Plaque Score (O'Leary) (FMPS)</measure>
    <time_frame>0, 7, 21 days</time_frame>
    <description>Quantitative plaque index, indicates presence of plaque on teeth. Six sites (3 buccal + 3 lingual / palatal) are considered for each tooth, to which a score is given:&#xD;
0: absence of plaque&#xD;
one third (1/3) of the surface shows plaque&#xD;
two thirds (2/3) of the surface show plaque&#xD;
more than 2/3 of the surface shows plaque&#xD;
Higher score means worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Calculus index (Volpe-Manhold index) (VMI)</measure>
    <time_frame>0, 7, 21 days</time_frame>
    <description>Assessment of tartar on lingual surface of lower anterior teeth, expressed in millimeters. Three measurements are taken for each tooth; mesio-lingual, central lingual and disto-lingual.&#xD;
Total score is the sum of all measurements of all six lower anterior teeth.&#xD;
Higher score means worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Stain index (Macpherson stain index) (S.I.)</measure>
    <time_frame>0, 7, 21 days</time_frame>
    <description>Assessment of tooth staining. Expressed via score and plus signs:&#xD;
0-1 mild stains + 1.1 - 2 moderate stains ++ 2.1 - 3 heavy stains +++&#xD;
Average stain value = sum of stain scores / total number of teeth&#xD;
Higher score means worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Periodontal Index</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Zinc L-Carnosine mouth rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zinc L-Carnosine</intervention_name>
    <description>Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily</description>
    <arm_group_label>Zinc L-Carnosine mouth rinse</arm_group_label>
    <other_name>Hepilor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine</intervention_name>
    <description>Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily</description>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <other_name>Curasept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily</description>
    <arm_group_label>Water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a PSR score greater than 2 that undergo a session of scaling and root&#xD;
             planing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of mouth rinses or local or general medication in the preceding three weeks&#xD;
&#xD;
          -  Any condition related with allergy or sensitivity with the mouth rinses ingredients&#xD;
&#xD;
          -  Systemic and chronic diseases in progress&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chiara Occhipinti, Professor</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>Doi H, Fujiwara M, Suzuki H, Niwa Y, Nakayama M, Shikata T, Odawara S, Takada Y, Kimura T, Kamikonya N, Hirota S. Polaprezinc reduces the severity of radiation-induced mucositis in head and neck cancer patients. Mol Clin Oncol. 2015 Mar;3(2):381-386. doi: 10.3892/mco.2014.479. Epub 2014 Dec 19.</citation>
    <PMID>25798271</PMID>
  </reference>
  <reference>
    <citation>Loe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000 Jun;50(3):129-39. doi: 10.1111/j.1875-595x.2000.tb00553.x.</citation>
    <PMID>10967765</PMID>
  </reference>
  <reference>
    <citation>Tartaglia GM, Kumar S, Fornari CD, Corti E, Connelly ST. Mouthwashes in the 21st century: a narrative review about active molecules and effectiveness on the periodontal outcomes. Expert Opin Drug Deliv. 2017 Aug;14(8):973-982. doi: 10.1080/17425247.2017.1260118. Epub 2016 Nov 20.</citation>
    <PMID>27835926</PMID>
  </reference>
  <reference>
    <citation>Van der Weijden FA, Van der Sluijs E, Ciancio SG, Slot DE. Can Chemical Mouthwash Agents Achieve Plaque/Gingivitis Control? Dent Clin North Am. 2015 Oct;59(4):799-829. doi: 10.1016/j.cden.2015.06.002.</citation>
    <PMID>26427569</PMID>
  </reference>
  <reference>
    <citation>Omatsu T, Naito Y, Handa O, Mizushima K, Hayashi N, Qin Y, Harusato A, Hirata I, Kishimoto E, Okada H, Uchiyama K, Ishikawa T, Takagi T, Yagi N, Kokura S, Ichikawa H, Yoshikawa T. Reactive oxygen species-quenching and anti-apoptotic effect of polaprezinc on indomethacin-induced small intestinal epithelial cell injury. J Gastroenterol. 2010 Jul;45(7):692-702. doi: 10.1007/s00535-010-0213-9. Epub 2010 Feb 20.</citation>
    <PMID>20174833</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 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>Periodontal index</keyword>
  <keyword>Pain</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Polaprezinc</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04430998
org study id: COCMFFP-M-01-2020
nct id: NCT04430998
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
A clinical trial to assess the effect of a Zinc-L-Carnosine-based mouth rinse on periodontal
      tissues and pain after scaling and root planing
A randomized, double blind, 3 group parallel study with random allocation of 75 patients to
      any of three groups; Zinc-L-Carnosine-based mouth rinse, Chlorhexidine mouth rinse and
      placebo (water) control. Three days after professional oral hygiene, which aimed at the
      normalization of the periodontal index, the primary (HI, VAS) and secondary (mSBI; FMPS; VMI;
      SI) outcomes of the study are measured to obtain baseline information, and then scaling and
      root planing are carried out.

      The participants will be advised to follow their regular oral hygiene procedures (tooth
      brushing) in addition to the allocated mouth rinse. They will be examined again for primary
      and secondary outcomes at 7 and 21 days.

      Clinical evaluation:

      Clinical examination of each participant will be done by a single examiner using the
      previously described VAS scale and a UNC periodontal probe (No. 5 explorer Hu-Friedy,
      Chicago, Ill). In addition to these indices, each subject will be asked to report any adverse
      events they have encountered during the experiment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Healing Index (H.I.)
time frame: 0, 7, 21 days
description: The Laundry-Turnbull and Howley index will be used to evaluate healing, considering the changes made by Pippi et al. In 2015. In particular, seven parameters will be assessed, to each of which a value of 1 or 0 will be assigned. The sum of the values will indicate the degree of healing to be compared between the different groups.
These seven parameters are: redness of mucosa, granulation tissue, suppuration, swelling, re-epithelialization, bleeding, pain on palpation.
Higher score means worse outcome.
measure: Change in the Visual Analogue Scale (VAS) of pain
time frame: 0, 7, 21 days
description: Participants will be asked to mark the perceived degree of pain on a scale of 100 dashes, with the lowest score being "no pain" and the highest "the worst pain".
Higher score means worse outcome.
measure: Change in Modified Sulcus Bleeding index (Mombelli) (mSBI)
time frame: 0, 7, 21 days
description: The clinical examination of each participant will be carried out by a single examiner using the UNC periodontal probe and the explorer n. 5 (Hu-Friedy, Chicago, III) to assess sulcus bleeding and assign a score: 0 absence of bleeding;
presence of bleeding on probing without redness and edema;
presence of bleeding on probing with redness and edema;
spontaneous bleeding.
6 sites (3 buccal + 3 lingual / palatal) are considered for each tooth.
Higher score means worse outcome.
measure: Change in Full Mouth Plaque Score (O'Leary) (FMPS)
time frame: 0, 7, 21 days
description: Quantitative plaque index, indicates presence of plaque on teeth. Six sites (3 buccal + 3 lingual / palatal) are considered for each tooth, to which a score is given:
0: absence of plaque
one third (1/3) of the surface shows plaque
two thirds (2/3) of the surface show plaque
more than 2/3 of the surface shows plaque
Higher score means worse outcome.
measure: Change in Calculus index (Volpe-Manhold index) (VMI)
time frame: 0, 7, 21 days
description: Assessment of tartar on lingual surface of lower anterior teeth, expressed in millimeters. Three measurements are taken for each tooth; mesio-lingual, central lingual and disto-lingual.
Total score is the sum of all measurements of all six lower anterior teeth.
Higher score means worse outcome.
measure: Change in Stain index (Macpherson stain index) (S.I.)
time frame: 0, 7, 21 days
description: Assessment of tooth staining. Expressed via score and plus signs:
0-1 mild stains + 1.1 - 2 moderate stains ++ 2.1 - 3 heavy stains +++
Average stain value = sum of stain scores / total number of teeth
Higher score means worse outcome.
arm group label: Zinc L-Carnosine mouth rinse
arm group type: Experimental
description: Using undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 60 seconds, 3 times daily
arm group label: Chlorhexidine
arm group type: Active Comparator
description: Using undiluted 10 ml of Chlorhexidine mouth rinse, retain for 60 seconds, 3 times daily
arm group label: Water
arm group type: Placebo Comparator
description: Mouth rinsing with 10 ml of water, retain for 60 seconds, 3 times daily
intervention type: Drug
intervention name: Zinc L-Carnosine
description: Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily
arm group label: Zinc L-Carnosine mouth rinse
other name: Hepilor
intervention type: Drug
intervention name: Chlorhexidine
description: Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily
arm group label: Chlorhexidine
other name: Curasept
intervention type: Other
intervention name: Water
description: Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily
arm group label: Water
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chiara Occhipinti, Professor
role: Principal Investigator
affiliation: University of Milan
last name: Chiara Occhipinti, Professor
phone: +393339155689
email: Chiara.Occhipinti@unimi.it
facility: 
country: Italy
citation: Doi H, Fujiwara M, Suzuki H, Niwa Y, Nakayama M, Shikata T, Odawara S, Takada Y, Kimura T, Kamikonya N, Hirota S. Polaprezinc reduces the severity of radiation-induced mucositis in head and neck cancer patients. Mol Clin Oncol. 2015 Mar;3(2):381-386. doi: 10.3892/mco.2014.479. Epub 2014 Dec 19.
PMID: 25798271
citation: Loe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000 Jun;50(3):129-39. doi: 10.1111/j.1875-595x.2000.tb00553.x.
PMID: 10967765
citation: Tartaglia GM, Kumar S, Fornari CD, Corti E, Connelly ST. Mouthwashes in the 21st century: a narrative review about active molecules and effectiveness on the periodontal outcomes. Expert Opin Drug Deliv. 2017 Aug;14(8):973-982. doi: 10.1080/17425247.2017.1260118. Epub 2016 Nov 20.
PMID: 27835926
citation: Van der Weijden FA, Van der Sluijs E, Ciancio SG, Slot DE. Can Chemical Mouthwash Agents Achieve Plaque/Gingivitis Control? Dent Clin North Am. 2015 Oct;59(4):799-829. doi: 10.1016/j.cden.2015.06.002.
PMID: 26427569
citation: Omatsu T, Naito Y, Handa O, Mizushima K, Hayashi N, Qin Y, Harusato A, Hirata I, Kishimoto E, Okada H, Uchiyama K, Ishikawa T, Takagi T, Yagi N, Kokura S, Ichikawa H, Yoshikawa T. Reactive oxygen species-quenching and anti-apoptotic effect of polaprezinc on indomethacin-induced small intestinal epithelial cell injury. J Gastroenterol. 2010 Jul;45(7):692-702. doi: 10.1007/s00535-010-0213-9. Epub 2010 Feb 20.
PMID: 20174833
responsible party type: Principal Investigator
investigator affiliation: University of Milan
investigator full name: Chiara Occhipinti
investigator title: Professor
mesh term: Chlorhexidine
mesh term: Polaprezinc
sharing ipd: No