<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/NCT02969928</url>
  </required_header>
  <id_info>
    <org_study_id>AmxMetClmCFA</org_study_id>
    <nct_id>NCT02969928</nct_id>
  </id_info>
  <brief_title>Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis</brief_title>
  <official_title>Full-mouth Periodontal Debridement Associated With Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis: Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual Paulista Júlio de Mesquita Filho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual Paulista Júlio de Mesquita Filho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement&#xD;
      combined with clarithromycin or amoxicillin + metronidazole association for the treatment of&#xD;
      generalized aggressive periodontitis (GAgP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study methodology is according to CONSORT-STATEMENT 2010 for randomized controlled&#xD;
      clinical trials.&#xD;
&#xD;
      Study Design&#xD;
&#xD;
      The study is designed as a prospective, interventional, parallel, triple blind, randomized,&#xD;
      controlled clinical trial aimed to assess the clinical outcomes of full-mouth ultrasonic&#xD;
      debridement combined with clarithromycin or amoxicillin + metronidazole association for the&#xD;
      treatment of generalized aggressive periodontitis (GAgP). The study was approved by Institute&#xD;
      of Science and Technology's (ICT - State University of São Paulo) Ethics Committee (protocol&#xD;
      1.079.307).&#xD;
&#xD;
      Source of data&#xD;
&#xD;
      The population of this study will be recruited among patients referred to the Science and&#xD;
      Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients will fill a&#xD;
      healthy history questionnaire to ensure that they are medically qualified for participate in&#xD;
      this study. Based on the power calculation for this study, 44 subjects divided into two&#xD;
      groups will be needed to achieve 80% power to detect a 0.8 mm difference in the clinical&#xD;
      attachment level (CAL) of patients.&#xD;
&#xD;
      Clinical Parameters&#xD;
&#xD;
      All clinical parameters will be assessed by a single blinded, trained and calibrated examiner&#xD;
      (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using a manual probe.&#xD;
      Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal,&#xD;
      distolingual, lingual, and mesiolingual) in all teeth, except third molars.&#xD;
&#xD;
      The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2)&#xD;
      Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket&#xD;
      to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to&#xD;
      cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of&#xD;
      sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area.&#xD;
&#xD;
      Calibration and Randomization&#xD;
&#xD;
      Initially, a total of ten patients presenting with GAgP will be selected. The designated&#xD;
      examiner (CFA) will measure CAL and PD in all patients twice within 24 hours, with an&#xD;
      interval of ≥ 1 hour between examinations. Then, the measures will be submitted to intraclass&#xD;
      correlation test and the examiner will be judged calibrated if reaches 90% agreement.&#xD;
&#xD;
      Patients will be allocated into two groups according to a computer-generated list. The&#xD;
      allocation will be implemented by an investigator (NCCS) who was not directly involved in the&#xD;
      examination or treatment procedures. All medication will be prepared and encased in identical&#xD;
      opaque coded bottles by a manipulation pharmacy on São José dos Campos/São Paulo.&#xD;
&#xD;
      Treatment Protocols&#xD;
&#xD;
      All patients will be treated with periodontal therapy through of the one-stage, full mouth,&#xD;
      ultrasonic debridement (FMUD). In a single session, patients will receive local anesthesia&#xD;
      and periodontal debridement with ultrasound equipment (Cavitron - Dentsply EUA) and&#xD;
      subgingival tips (UI25KSF10S, Hu-Friedy). All diseased sites will be instrumented in this one&#xD;
      session. The debridement session will be performed by a single experienced and trained&#xD;
      periodontist (MPS), different from the examiner. Immediately before the mechanical therapy,&#xD;
      patients will be allocated in one of the two treatment protocols:&#xD;
&#xD;
        1. Clarithromycin (CLM) group (n = 22): FMUD + CLM 500 mg bid, for 7 days and&#xD;
&#xD;
        2. Amoxicillin (AMX) + metronidazole (MET) group (n = 22): FMUD + (AMX 500 mg tid + MET 400&#xD;
           mg tid, both for 7 days.&#xD;
&#xD;
      All patients will start taking the pills immediately before of the FMUD session.&#xD;
&#xD;
      Compliance and Adverse Effects&#xD;
&#xD;
      After 7 days of periodontal treatment, patients will be asked to return any medication not&#xD;
      taken and/or the empty bottles. The number of pills not taken by the subject will be&#xD;
      documented. Moreover, patients will be instructed to return a self-report form filled about&#xD;
      any possible adverse effects in order to help evaluate their adherence to the systemic&#xD;
      antimicrobial regimen.&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      Mean and standard deviation will be calculated for each parameter. The normal distribution of&#xD;
      the data will be analyzed by Shapiro-Wilk test. Data from clinical measurements will be&#xD;
      subjected to analysis of variance (repeated measures) for inter and intra-group comparison.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 2/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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Clinical Attachment Level (CAL)</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Evaluate the difference between baseline and 6 months CAL measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Probing Depth (PB)</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Evaluate the difference between baseline and 6 months PB measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bleeding on Probe (BoP)</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>Evaluate the difference between baseline and 6 months BoP measures.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compliance</measure>
    <time_frame>One week post treatment</time_frame>
    <description>After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Effects That May be Related to Antibiotic Treatment</measure>
    <time_frame>One week post treatment</time_frame>
    <description>Patients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Aggressive Periodontitis</condition>
  <arm_group>
    <arm_group_label>Amoxicillin and Metronidazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clarithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Full-mouth ultrasonic debridement</intervention_name>
    <description>Full-mouth ultrasonic debridement will be performed in order to treat diseased sites</description>
    <arm_group_label>Amoxicillin and Metronidazole</arm_group_label>
    <arm_group_label>Clarithromycin</arm_group_label>
    <other_name>Periodontal debridement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin</intervention_name>
    <description>Administration of Clarithromycin 500mg bid for 7 days</description>
    <arm_group_label>Clarithromycin</arm_group_label>
    <other_name>Biaxin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>Administration of Amoxicillin 500mg tid for 7 days.</description>
    <arm_group_label>Amoxicillin and Metronidazole</arm_group_label>
    <other_name>Amoxil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <description>Administration of Metronidazole 400mg tid for 7 days.</description>
    <arm_group_label>Amoxicillin and Metronidazole</arm_group_label>
    <other_name>Flagyl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of GAgP (AAP, 1999);&#xD;
&#xD;
          2. presence of ≥20 teeth;&#xD;
&#xD;
          3. presence of ≥ 6 sites presenting PD ≥ 5mm with bleeding on probing (BOP) and ≥2 sites&#xD;
             with PD ≥7mm (including incisors and first molars, in addition to other two&#xD;
             non-contiguous teeth);&#xD;
&#xD;
          4. good general health;&#xD;
&#xD;
          5. ≤ 35 years old; and&#xD;
&#xD;
          6. agree to participate in the study and sign a written informed consent. All subjects&#xD;
             will be individually informed about the objectives, probable risks and benefits of the&#xD;
             protocol treatment (according to Resolution nº196 of October 1996 and to the&#xD;
             Professional Code of Dental Ethics - 179/93).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. pregnancy or lactating;&#xD;
&#xD;
          2. suffer from any systemic disease (e.g. cardiovascular disorders, diabetes, blood&#xD;
             dyscrasias, immunodeficiency, etc) which could alter the course of periodontal&#xD;
             disease;&#xD;
&#xD;
          3. took antimicrobials in the previous 6 months;&#xD;
&#xD;
          4. taking long-term anti-inflammatory drugs;&#xD;
&#xD;
          5. previous periodontal treatment within the last 12 months;&#xD;
&#xD;
          6. smokers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro P Santamaria, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>College of Dentistry - São José dos Campos, Sao Paulo State University</name>
      <address>
        <city>São José dos Campos</city>
        <state>SP</state>
        <zip>12245-310</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Pradeep AR, Kathariya R. Clarithromycin, as an adjunct to non surgical periodontal therapy for chronic periodontitis: a double blinded, placebo controlled, randomized clinical trial. Arch Oral Biol. 2011 Oct;56(10):1112-9. doi: 10.1016/j.archoralbio.2011.03.021. Epub 2011 May 6.</citation>
    <PMID>21529775</PMID>
  </reference>
  <reference>
    <citation>Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.</citation>
    <PMID>20447259</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>May 4, 2020</results_first_submitted>
  <results_first_submitted_qc>August 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2020</results_first_posted>
  <last_update_submitted>December 23, 2021</last_update_submitted>
  <last_update_submitted_qc>December 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</investigator_affiliation>
    <investigator_full_name>Mauro Pedrine Santamaria</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Full-mouth ultrasonic debridement</keyword>
  <keyword>Clarithromycin</keyword>
  <keyword>Amoxicillin</keyword>
  <keyword>Metronidazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Aggressive Periodontitis</mesh_term>
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Amoxicillin and Metronidazole</title>
          <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
        </group>
        <group group_id="P2">
          <title>Clarithromycin</title>
          <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Amoxicillin and Metronidazole</title>
          <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
        </group>
        <group group_id="B2">
          <title>Clarithromycin</title>
          <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Clinical Attachment Level (CAL)</title>
        <description>Evaluate the difference between baseline and 6 months CAL measures.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Amoxicillin and Metronidazole</title>
            <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Clarithromycin</title>
            <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Clinical Attachment Level (CAL)</title>
          <description>Evaluate the difference between baseline and 6 months CAL measures.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="0.7"/>
                    <measurement group_id="O2" value="3.62" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.5"/>
                    <measurement group_id="O2" value="3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="0.5"/>
                    <measurement group_id="O2" value="3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Probing Depth (PB)</title>
        <description>Evaluate the difference between baseline and 6 months PB measures.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Amoxicillin and Metronidazole</title>
            <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Clarithromycin</title>
            <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Probing Depth (PB)</title>
          <description>Evaluate the difference between baseline and 6 months PB measures.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.44" spread="0.6"/>
                    <measurement group_id="O2" value="3.41" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.3"/>
                    <measurement group_id="O2" value="2.7" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.3"/>
                    <measurement group_id="O2" value="2.7" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Bleeding on Probe (BoP)</title>
        <description>Evaluate the difference between baseline and 6 months BoP measures.</description>
        <time_frame>Baseline, 3 and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Amoxicillin and Metronidazole</title>
            <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Clarithromycin</title>
            <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bleeding on Probe (BoP)</title>
          <description>Evaluate the difference between baseline and 6 months BoP measures.</description>
          <units>% of sites with bleeding on probe</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="17.4"/>
                    <measurement group_id="O2" value="43.7" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.2" spread="9.3"/>
                    <measurement group_id="O2" value="24.8" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" spread="8.3"/>
                    <measurement group_id="O2" value="23.3" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Compliance</title>
        <description>After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.</description>
        <time_frame>One week post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Amoxicillin and Metronidazole</title>
            <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Clarithromycin</title>
            <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Compliance</title>
          <description>After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title># of patients that did not take ≥1 pills</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title># of patients that interrupted the drug intake</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Adverse Effects That May be Related to Antibiotic Treatment</title>
        <description>Patients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.</description>
        <time_frame>One week post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Amoxicillin and Metronidazole</title>
            <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
          </group>
          <group group_id="O2">
            <title>Clarithromycin</title>
            <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Effects That May be Related to Antibiotic Treatment</title>
          <description>Patients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stomach pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea/vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metallic taste</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea/abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin wounds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>during 7 days post-treatment</time_frame>
      <desc>7 days after the therapy patients returned to fill out a self-report form about 8 possible adverse effects resulting from the antibiotic intake, based on Martys: Headache, Stomach pain, Nausea/vomiting, Metallic taste, Diarrhea/ abdominal pain, Drowsiness, Itching and Skin wounds.</desc>
      <group_list>
        <group group_id="E1">
          <title>Amoxicillin and Metronidazole</title>
          <description>In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Amoxicillin: Administration of Amoxicillin 500mg tid for 7 days.&#xD;
Metronidazole: Administration of Metronidazole 400mg tid for 7 days.</description>
        </group>
        <group group_id="E2">
          <title>Clarithromycin</title>
          <description>In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.&#xD;
Full-mouth ultrasonic debridement: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites&#xD;
Clarithromycin: Administration of Clarithromycin 500mg bid for 7 days</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Diarrhea/ abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nausea/vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Metallic taste</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Itching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Skin wounds</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Mauro Pedrine Santamaria</name_or_title>
      <organization>São Paulo State University - Unesp</organization>
      <phone>+5516981937777</phone>
      <email>mauro.santamaria@unesp.br</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02969928
org study id: AmxMetClmCFA
nct id: NCT02969928
lead sponsor: 
has dmc: No
The aim of this study is to assess the clinical outcomes of full-mouth ultrasonic debridement
      combined with clarithromycin or amoxicillin + metronidazole association for the treatment of
      generalized aggressive periodontitis (GAgP).
The study methodology is according to CONSORT-STATEMENT 2010 for randomized controlled
      clinical trials.

      Study Design

      The study is designed as a prospective, interventional, parallel, triple blind, randomized,
      controlled clinical trial aimed to assess the clinical outcomes of full-mouth ultrasonic
      debridement combined with clarithromycin or amoxicillin + metronidazole association for the
      treatment of generalized aggressive periodontitis (GAgP). The study was approved by Institute
      of Science and Technology's (ICT - State University of São Paulo) Ethics Committee (protocol
      1.079.307).

      Source of data

      The population of this study will be recruited among patients referred to the Science and
      Technology Institute - ICT- São José dos Campos, College of Dentistry. Patients will fill a
      healthy history questionnaire to ensure that they are medically qualified for participate in
      this study. Based on the power calculation for this study, 44 subjects divided into two
      groups will be needed to achieve 80% power to detect a 0.8 mm difference in the clinical
      attachment level (CAL) of patients.

      Clinical Parameters

      All clinical parameters will be assessed by a single blinded, trained and calibrated examiner
      (CFA) before periodontal therapy (baseline) and at 3 and 6 months after using a manual probe.
      Measurements will be done at six sites per tooth (mesiobuccal, buccal, disto-buccal,
      distolingual, lingual, and mesiolingual) in all teeth, except third molars.

      The following clinical parameters will be evaluated: 1) Full-mouth plaque index (FMPI); 2)
      Bleeding on probing (BoP); 3) Probing depth (PD): distance from the bottom of sulcus/pocket
      to gingival margin; 4) Gingival recession (GM): distance from the free gingival margin to
      cement-enamel junction (CEJ); 5) Clinical attachment level (CAL): distance from bottom of
      sulcus/pocket to the CEJ. The CEJ will be identified by careful probe on cervical area.

      Calibration and Randomization

      Initially, a total of ten patients presenting with GAgP will be selected. The designated
      examiner (CFA) will measure CAL and PD in all patients twice within 24 hours, with an
      interval of ≥ 1 hour between examinations. Then, the measures will be submitted to intraclass
      correlation test and the examiner will be judged calibrated if reaches 90% agreement.

      Patients will be allocated into two groups according to a computer-generated list. The
      allocation will be implemented by an investigator (NCCS) who was not directly involved in the
      examination or treatment procedures. All medication will be prepared and encased in identical
      opaque coded bottles by a manipulation pharmacy on São José dos Campos/São Paulo.

      Treatment Protocols

      All patients will be treated with periodontal therapy through of the one-stage, full mouth,
      ultrasonic debridement (FMUD). In a single session, patients will receive local anesthesia
      and periodontal debridement with ultrasound equipment (Cavitron - Dentsply EUA) and
      subgingival tips (UI25KSF10S, Hu-Friedy). All diseased sites will be instrumented in this one
      session. The debridement session will be performed by a single experienced and trained
      periodontist (MPS), different from the examiner. Immediately before the mechanical therapy,
      patients will be allocated in one of the two treatment protocols:

        1. Clarithromycin (CLM) group (n = 22): FMUD + CLM 500 mg bid, for 7 days and

        2. Amoxicillin (AMX) + metronidazole (MET) group (n = 22): FMUD + (AMX 500 mg tid + MET 400
           mg tid, both for 7 days.

      All patients will start taking the pills immediately before of the FMUD session.

      Compliance and Adverse Effects

      After 7 days of periodontal treatment, patients will be asked to return any medication not
      taken and/or the empty bottles. The number of pills not taken by the subject will be
      documented. Moreover, patients will be instructed to return a self-report form filled about
      any possible adverse effects in order to help evaluate their adherence to the systemic
      antimicrobial regimen.

      Statistical analysis

      Mean and standard deviation will be calculated for each parameter. The normal distribution of
      the data will be analyzed by Shapiro-Wilk test. Data from clinical measurements will be
      subjected to analysis of variance (repeated measures) for inter and intra-group comparison.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Clinical Attachment Level (CAL)
time frame: Baseline, 3 and 6 months
description: Evaluate the difference between baseline and 6 months CAL measures.
measure: Change in Probing Depth (PB)
time frame: Baseline, 3 and 6 months
description: Evaluate the difference between baseline and 6 months PB measures.
measure: Change in Bleeding on Probe (BoP)
time frame: Baseline, 3 and 6 months
description: Evaluate the difference between baseline and 6 months BoP measures.
measure: Compliance
time frame: One week post treatment
description: After 7 days of periodontal treatment, patients will be asked to return any medication not taken and/or the empty bottles. The number of pills not taken by the subject will be documented in order to evaluate compliance.
measure: Adverse Effects That May be Related to Antibiotic Treatment
time frame: One week post treatment
description: Patients will be instructed to fill a self-report form about any possible adverse effects in order to help evaluate their adherence to the systemic antimicrobial regimen.
arm group label: Amoxicillin and Metronidazole
arm group type: Active Comparator
description: In this group (n = 23), patients will take Amoxicillin 500 mg tid for 7 days and Metronidazole 400 mg tid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
arm group label: Clarithromycin
arm group type: Experimental
description: In this group (n = 23), patients will take Clarithromycin 500 mg bid for 7 days and full-mouth ultrasonic debridement will be performed to treat diseased sites.
intervention type: Procedure
intervention name: Full-mouth ultrasonic debridement
description: Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
arm group label: Amoxicillin and Metronidazole
arm group label: Clarithromycin
other name: Periodontal debridement
intervention type: Drug
intervention name: Clarithromycin
description: Administration of Clarithromycin 500mg bid for 7 days
arm group label: Clarithromycin
other name: Biaxin
intervention type: Drug
intervention name: Amoxicillin
description: Administration of Amoxicillin 500mg tid for 7 days.
arm group label: Amoxicillin and Metronidazole
other name: Amoxil
intervention type: Drug
intervention name: Metronidazole
description: Administration of Metronidazole 400mg tid for 7 days.
arm group label: Amoxicillin and Metronidazole
other name: Flagyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro P Santamaria, PhD
role: Principal Investigator
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
facility: 
country: Brazil
citation: Pradeep AR, Kathariya R. Clarithromycin, as an adjunct to non surgical periodontal therapy for chronic periodontitis: a double blinded, placebo controlled, randomized clinical trial. Arch Oral Biol. 2011 Oct;56(10):1112-9. doi: 10.1016/j.archoralbio.2011.03.021. Epub 2011 May 6.
PMID: 21529775
citation: Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.
PMID: 20447259
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Mauro Pedrine Santamaria
investigator title: Professor
mesh term: Periodontitis
mesh term: Aggressive Periodontitis
mesh term: Aggression
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Clarithromycin
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 