<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/NCT02197260</url>
  </required_header>
  <id_info>
    <org_study_id>320030-122089</org_study_id>
    <secondary_id>2008DR4228</secondary_id>
    <nct_id>NCT02197260</nct_id>
  </id_info>
  <brief_title>Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing</brief_title>
  <acronym>GAR</acronym>
  <official_title>Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing on Clinical, Microbiological and Systemic Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Geneva, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is common practice to carry out the therapy of periodontal diseases in two phases. In a&#xD;
      first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are&#xD;
      removed using a cleaning method called &quot;scaling and root planing&quot; (SRP). After three to six&#xD;
      months the case is evaluated and, if necessary, further treatment is provided, usually taking&#xD;
      a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics&#xD;
      on clinical outcomes have been shown repeatedly but specific indications for antibiotics in&#xD;
      subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to&#xD;
      be issues of a long lasting controversy.This study assessed the differential outcomes of&#xD;
      periodontal therapy supplemented with amoxicillin-metronidazole during either the&#xD;
      non-surgical or the surgical treatment phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single center, randomized placebo controlled crossover clinical trial with a one-year&#xD;
      follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated chronic&#xD;
      or aggressive periodontitis were randomized into two treatment groups. A: Antibiotics (3/d&#xD;
      500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase&#xD;
      of periodontal therapy (T1), and placebo during the second, surgical phase (T2). B: Placebo&#xD;
      during T1, and antibiotics during T2. Persistence of sites with a probing depth (PD) &gt;4 mm&#xD;
      and bleeding on probing (BOP) was the primary outcome. Evaluations were made three months&#xD;
      after T1, as well as 6 and 12 months after T2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of persisting pockets &gt;4 mm bleeding upon probing</measure>
    <time_frame>one year after therapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pocket depth of sites with baseline PD &gt;4 mm</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>one year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Protocol A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protocol B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo during the first, non-surgical phase of periodontal therapy (T1), and antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the second, surgical phase (T2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days</intervention_name>
    <description>Systemic antibiotics after sub gingival mechanical debridement</description>
    <arm_group_label>Protocol A</arm_group_label>
    <arm_group_label>Protocol B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Untreated moderate to advanced periodontitis (at least 4 teeth with a probing pocket&#xD;
             depth (PD) &gt;4 mm, clinical attachment loss of at least 2 mm and radiographic evidence&#xD;
             of bone loss)&#xD;
&#xD;
          -  Presence of at least 12 scorable teeth (not including 3rd molars, teeth with&#xD;
             orthodontic appliances, bridges, crowns or implants)&#xD;
&#xD;
          -  Aggregatibacter actinomycetemcomitans-positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or&#xD;
             disorders that compromise wound healing, radiation or immunosuppressive therapy)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Systemic antibiotics taken within the previous two months&#xD;
&#xD;
          -  Use of non-steroid anti-inflammatory drugs&#xD;
&#xD;
          -  Confirmed or suspected intolerance to 5-nitroimidazole-derivatives or amoxicillin&#xD;
             subgingival SRP or surgical periodontal therapy in the last year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Mombelli, Dr.med.dent.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Geneva</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Geneva School of Dental Medicine</name>
      <address>
        <city>Geneva</city>
        <zip>CH-1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Almaghlouth AA, Cionca N, Cancela JA, Decaillet F, Courvoisier DS, Giannopoulou C, Mombelli A. Effect of periodontal treatment on peak serum levels of inflammatory markers. Clin Oral Investig. 2014 Dec;18(9):2113-21. doi: 10.1007/s00784-014-1187-4. Epub 2014 Jan 23.</citation>
    <PMID>24452825</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Geneva, Switzerland</investigator_affiliation>
    <investigator_full_name>Andrea Mombelli</investigator_full_name>
    <investigator_title>Prof. Dr.med.dent.</investigator_title>
  </responsible_party>
  <keyword>Periodontitis</keyword>
  <keyword>amoxicillin</keyword>
  <keyword>metronidazole</keyword>
  <keyword>case management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</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>
  </intervention_browse>
  <!-- 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/NCT02197260
org study id: 320030-122089
secondary id: 2008DR4228
nct id: NCT02197260
lead sponsor: 
has dmc: No
It is common practice to carry out the therapy of periodontal diseases in two phases. In a
      first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are
      removed using a cleaning method called "scaling and root planing" (SRP). After three to six
      months the case is evaluated and, if necessary, further treatment is provided, usually taking
      a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics
      on clinical outcomes have been shown repeatedly but specific indications for antibiotics in
      subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to
      be issues of a long lasting controversy.This study assessed the differential outcomes of
      periodontal therapy supplemented with amoxicillin-metronidazole during either the
      non-surgical or the surgical treatment phase.
Single center, randomized placebo controlled crossover clinical trial with a one-year
      follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated chronic
      or aggressive periodontitis were randomized into two treatment groups. A: Antibiotics (3/d
      500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase
      of periodontal therapy (T1), and placebo during the second, surgical phase (T2). B: Placebo
      during T1, and antibiotics during T2. Persistence of sites with a probing depth (PD) >4 mm
      and bleeding on probing (BOP) was the primary outcome. Evaluations were made three months
      after T1, as well as 6 and 12 months after T2.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of persisting pockets >4 mm bleeding upon probing
time frame: one year after therapy
measure: Pocket depth of sites with baseline PD >4 mm
time frame: one year
measure: Adverse events
time frame: one year
arm group label: Protocol A
arm group type: Experimental
description: Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2)
arm group label: Protocol B
arm group type: Active Comparator
description: Placebo during the first, non-surgical phase of periodontal therapy (T1), and antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the second, surgical phase (T2)
intervention type: Drug
intervention name: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
description: Systemic antibiotics after sub gingival mechanical debridement
arm group label: Protocol A
arm group label: Protocol B
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: No
last name: Andrea Mombelli, Dr.med.dent.
role: Principal Investigator
affiliation: University of Geneva
facility: 
country: Switzerland
citation: Almaghlouth AA, Cionca N, Cancela JA, Decaillet F, Courvoisier DS, Giannopoulou C, Mombelli A. Effect of periodontal treatment on peak serum levels of inflammatory markers. Clin Oral Investig. 2014 Dec;18(9):2113-21. doi: 10.1007/s00784-014-1187-4. Epub 2014 Jan 23.
PMID: 24452825
responsible party type: Principal Investigator
investigator affiliation: University of Geneva, Switzerland
investigator full name: Andrea Mombelli
investigator title: Prof. Dr.med.dent.
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Amoxicillin
mesh term: Metronidazole