<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/NCT02195765</url>
  </required_header>
  <id_info>
    <org_study_id>EMD24</org_study_id>
    <nct_id>NCT02195765</nct_id>
  </id_info>
  <brief_title>Randomized Clinical Trial of Enamel Matrix Derivative: Radiographic Analysis</brief_title>
  <official_title>Two-year Randomized Clinical Trial of Enamel Matrix Derivative Treated Infrabony Defects: Radiographic Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a split-mouth, double-blind randomized controlled trial. Computerized linear&#xD;
      radiographic measurements were used to detect infrabony defects treated with open flap&#xD;
      debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months. Ten&#xD;
      patients presenting 2 or more defects were selected (43 defects). An individualized film&#xD;
      holder was used to take standardized radiographs at baseline and after 24 months. Images were&#xD;
      digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the&#xD;
      alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a split-mouth randomized controlled trial. Patients were recruited among the ones&#xD;
      seeking for periodontal treatment at the Post-graduate Clinic of Periodontics using the&#xD;
      following inclusion criteria: (1) diagnosis of chronic periodontitis15; (2) presence of at&#xD;
      least one pair of interproximal infrabony defects (2-3 walls) adjacent to vital anterior or&#xD;
      premolar teeth; (3) absence of 2 and 3 mobility degrees16; (4) probing pocket depth (PPD)≥&#xD;
      5mm; (5) full-mouth plaque score ≤ 20%17; and (6) keratinized tissue width of at least 2mm.&#xD;
      The exclusion criteria were: (1) presence of any systemic disease that could interfere with&#xD;
      periodontal treatment; (2) infrabony defects with trans-surgical depth ≤4mm; (3) antibiotic&#xD;
      treatment administered during the last 6 months.&#xD;
&#xD;
      The patients participating in the study were volunteers who received and gave informed&#xD;
      consent and were included in the study from June to October 2002.&#xD;
&#xD;
      Following initial examination, all patients underwent oral hygiene instruction and full-mouth&#xD;
      supra- and sub-gingival scaling and root planning under local anesthesia. Patients were&#xD;
      re-evaluated after completion of the initial therapy to determine their response to therapy&#xD;
      and to confirm the need for periodontal surgery. Before surgery, for each pair of defects,&#xD;
      one defect was randomly assigned to test (EMD) and one to control (OFD) treatment by toss of&#xD;
      a coin. Both defects were treated at the same surgical time. When a patient presented with&#xD;
      more than one pair of defects, only one pair was treated per day. Following local anesthesia,&#xD;
      all sites were treated with reflection of a full thickness mucoperiosteal flap after&#xD;
      intra-sulcular incisions. The exposed roots and osseous defects were debrided with hand&#xD;
      instruments, and the surgical wound was rinsed with saline.&#xD;
&#xD;
      After that, the flaps of the OFD sites were repositioned and sutured using 5-0 nylon sutures.&#xD;
      The EMD sites were dried with non-woven gauze, roots were conditioned with 24%&#xD;
      ethylenediaminotetracetic acid (EDTA) gel (pH 6.7) for 2 minutes. The defect was thoroughly&#xD;
      rinsed with saline, and EMD gel was applied to the root surfaces according to the&#xD;
      manufacturer's instructions. The flaps were then replaced for primary closure and sutured&#xD;
      with 5-0 nylon sutures. The sutures were removed after 7 days. All surgeries were performed&#xD;
      by the same investigator. All patients were prescribed 0.12% chlorhexidine digluconate and&#xD;
      instructed to rinse gently twice a day for 4 weeks. Analgesics were prescribed to be taken as&#xD;
      needed, and all patients were seen once a week, for 8 weeks, for professional tooth cleaning.&#xD;
      Subsequently, the patients were maintained in a supportive periodontal program (ie,&#xD;
      professional tooth cleaning and reinforcement of self-administered oral hygiene measures) at&#xD;
      2-month intervals up to 6-month time and then every 3 months until final examination at 24&#xD;
      months.&#xD;
&#xD;
      Standardized periapical radiographs were taken at baseline evaluation, immediately before&#xD;
      surgery and at 24 months follow-up. Individually customized bite blocks employing a reference&#xD;
      occlusal stent and film holders were used to obtain reproducible exposed films at each&#xD;
      radiographic control. All radiographs were evaluated by a single calibrated examiner, blind&#xD;
      to time and treatment.&#xD;
&#xD;
      Analyses of the radiographic outcomes were performed using computerized linear measurements&#xD;
      with image analysis software. The radiographs were previously scanned in digital format by a&#xD;
      scanner at a resolution of 500dpi/8bits.&#xD;
&#xD;
      The radiographic analysis was based in anatomical landmarks (CEJ, BD and AC) that were&#xD;
      identified on the scanned radiographs. All linear measurements were recorded by a blinded,&#xD;
      calibrated examiner. The following outcomes were measured at radiographs taken at baseline&#xD;
      and after 24 months:&#xD;
&#xD;
        1. Distance from the CEJ to the bottom of the defect (BD). The most coronal area where the&#xD;
           periodontal ligament maintained an even width was identified to measure the most apical&#xD;
           extension of the infrabony defect;&#xD;
&#xD;
        2. Distance from the CEJ to the bone crest (BC);&#xD;
&#xD;
        3. Infrabony defect angle was defined by two lines that represented the root surface of the&#xD;
           involved tooth (CEJ-BD) and the bone defect surface (BD-BC).&#xD;
&#xD;
      The distance from the CEJ to the bottom of the defect (BD) was considered the primary&#xD;
      outcome. CEJ-BC and defect angle were secondary outcomes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2002</start_date>
  <completion_date type="Actual">October 2005</completion_date>
  <primary_completion_date type="Actual">October 2004</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distance from the cemento-enamel junction (CEJ) to the bottom of the defect (BD)</measure>
    <time_frame>24 months</time_frame>
    <description>The most coronal area where the periodontal ligament maintained an even width was identified to measure the most apical extension of the infrabony defect</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distance from the CEJ to the bone crest</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infrabony defect angle</measure>
    <time_frame>24 months</time_frame>
    <description>Infrabony defect angle was defined by two lines that represented the root surface of the involved tooth (CEJ-BD) and the bone defect surface (BD-BC)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>enamel matrix derivative</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open flap debridement associated with Enamel matrix derivative gel (Emdogain, Straumann)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open flap debridment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Open flap debridement</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>enamel matrix derivative</intervention_name>
    <description>Open flap debridement associated with enamel matrix derivative</description>
    <arm_group_label>enamel matrix derivative</arm_group_label>
    <other_name>Emdogain, Straumann</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open flap debridement</intervention_name>
    <description>Open flap debridement</description>
    <arm_group_label>Open flap debridment</arm_group_label>
    <arm_group_label>enamel matrix derivative</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diagnosis of chronic periodontitis&#xD;
&#xD;
          2. presence of at least one pair of interproximal infrabony defects (2-3 walls) adjacent&#xD;
             to vital anterior or premolar teeth&#xD;
&#xD;
          3. absence of 2 and 3 mobility degrees&#xD;
&#xD;
          4. probing pocket depth (PPD)≥ 5mm&#xD;
&#xD;
          5. full-mouth plaque score ≤ 20%&#xD;
&#xD;
          6. keratinized tissue width of at least 2mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. presence of any systemic disease that could interfere with periodontal treatment&#xD;
&#xD;
          2. infrabony defects with trans-surgical depth ≤4mm&#xD;
&#xD;
          3. antibiotic treatment administered during the last 6 months -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luiz Antonio PA Lima, Associate</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculdade de Odontologia da Universidade de São Paulo (FOUSP)</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Chambrone D, Pasin IM, Chambrone L, Pannuti CM, Conde MC, Lima LA. Treatment of infrabony defects with or without enamel matrix proteins: a 24-month follow-up randomized pilot study. Quintessence Int. 2010 Feb;41(2):125-34.</citation>
    <PMID>20165744</PMID>
  </results_reference>
  <results_reference>
    <citation>Chambrone D, Pasin IM, Conde MC, Panutti C, Carneiro S, Lima LA. Effect of enamel matrix proteins on the treatment of intrabony defects: a split-mouth randomized controlled trial study. Braz Oral Res. 2007 Jul-Sep;21(3):241-6. doi: 10.1590/s1806-83242007000300009.</citation>
    <PMID>17710290</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Mariana Ragghianti Zangrando</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Chronic Periodontitis</keyword>
  <keyword>Periodontal disease</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>
  <!-- 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/NCT02195765
org study id: EMD24
nct id: NCT02195765
lead sponsor: 
has dmc: No
This is a split-mouth, double-blind randomized controlled trial. Computerized linear
      radiographic measurements were used to detect infrabony defects treated with open flap
      debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months. Ten
      patients presenting 2 or more defects were selected (43 defects). An individualized film
      holder was used to take standardized radiographs at baseline and after 24 months. Images were
      digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the
      alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.
This was a split-mouth randomized controlled trial. Patients were recruited among the ones
      seeking for periodontal treatment at the Post-graduate Clinic of Periodontics using the
      following inclusion criteria: (1) diagnosis of chronic periodontitis15; (2) presence of at
      least one pair of interproximal infrabony defects (2-3 walls) adjacent to vital anterior or
      premolar teeth; (3) absence of 2 and 3 mobility degrees16; (4) probing pocket depth (PPD)≥
      5mm; (5) full-mouth plaque score ≤ 20%17; and (6) keratinized tissue width of at least 2mm.
      The exclusion criteria were: (1) presence of any systemic disease that could interfere with
      periodontal treatment; (2) infrabony defects with trans-surgical depth ≤4mm; (3) antibiotic
      treatment administered during the last 6 months.

      The patients participating in the study were volunteers who received and gave informed
      consent and were included in the study from June to October 2002.

      Following initial examination, all patients underwent oral hygiene instruction and full-mouth
      supra- and sub-gingival scaling and root planning under local anesthesia. Patients were
      re-evaluated after completion of the initial therapy to determine their response to therapy
      and to confirm the need for periodontal surgery. Before surgery, for each pair of defects,
      one defect was randomly assigned to test (EMD) and one to control (OFD) treatment by toss of
      a coin. Both defects were treated at the same surgical time. When a patient presented with
      more than one pair of defects, only one pair was treated per day. Following local anesthesia,
      all sites were treated with reflection of a full thickness mucoperiosteal flap after
      intra-sulcular incisions. The exposed roots and osseous defects were debrided with hand
      instruments, and the surgical wound was rinsed with saline.

      After that, the flaps of the OFD sites were repositioned and sutured using 5-0 nylon sutures.
      The EMD sites were dried with non-woven gauze, roots were conditioned with 24%
      ethylenediaminotetracetic acid (EDTA) gel (pH 6.7) for 2 minutes. The defect was thoroughly
      rinsed with saline, and EMD gel was applied to the root surfaces according to the
      manufacturer's instructions. The flaps were then replaced for primary closure and sutured
      with 5-0 nylon sutures. The sutures were removed after 7 days. All surgeries were performed
      by the same investigator. All patients were prescribed 0.12% chlorhexidine digluconate and
      instructed to rinse gently twice a day for 4 weeks. Analgesics were prescribed to be taken as
      needed, and all patients were seen once a week, for 8 weeks, for professional tooth cleaning.
      Subsequently, the patients were maintained in a supportive periodontal program (ie,
      professional tooth cleaning and reinforcement of self-administered oral hygiene measures) at
      2-month intervals up to 6-month time and then every 3 months until final examination at 24
      months.

      Standardized periapical radiographs were taken at baseline evaluation, immediately before
      surgery and at 24 months follow-up. Individually customized bite blocks employing a reference
      occlusal stent and film holders were used to obtain reproducible exposed films at each
      radiographic control. All radiographs were evaluated by a single calibrated examiner, blind
      to time and treatment.

      Analyses of the radiographic outcomes were performed using computerized linear measurements
      with image analysis software. The radiographs were previously scanned in digital format by a
      scanner at a resolution of 500dpi/8bits.

      The radiographic analysis was based in anatomical landmarks (CEJ, BD and AC) that were
      identified on the scanned radiographs. All linear measurements were recorded by a blinded,
      calibrated examiner. The following outcomes were measured at radiographs taken at baseline
      and after 24 months:

        1. Distance from the CEJ to the bottom of the defect (BD). The most coronal area where the
           periodontal ligament maintained an even width was identified to measure the most apical
           extension of the infrabony defect;

        2. Distance from the CEJ to the bone crest (BC);

        3. Infrabony defect angle was defined by two lines that represented the root surface of the
           involved tooth (CEJ-BD) and the bone defect surface (BD-BC).

      The distance from the CEJ to the bottom of the defect (BD) was considered the primary
      outcome. CEJ-BC and defect angle were secondary outcomes
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Distance from the cemento-enamel junction (CEJ) to the bottom of the defect (BD)
time frame: 24 months
description: The most coronal area where the periodontal ligament maintained an even width was identified to measure the most apical extension of the infrabony defect
measure: Distance from the CEJ to the bone crest
time frame: 24 months
measure: Infrabony defect angle
time frame: 24 months
description: Infrabony defect angle was defined by two lines that represented the root surface of the involved tooth (CEJ-BD) and the bone defect surface (BD-BC)
arm group label: enamel matrix derivative
arm group type: Experimental
description: Open flap debridement associated with Enamel matrix derivative gel (Emdogain, Straumann)
arm group label: Open flap debridment
arm group type: Active Comparator
description: Open flap debridement
intervention type: Drug
intervention name: enamel matrix derivative
description: Open flap debridement associated with enamel matrix derivative
arm group label: enamel matrix derivative
other name: Emdogain, Straumann
intervention type: Procedure
intervention name: Open flap debridement
description: Open flap debridement
arm group label: Open flap debridment
arm group label: enamel matrix derivative
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luiz Antonio PA Lima, Associate
role: Principal Investigator
affiliation: University of São Paulo
facility: 
country: Brazil
citation: Chambrone D, Pasin IM, Chambrone L, Pannuti CM, Conde MC, Lima LA. Treatment of infrabony defects with or without enamel matrix proteins: a 24-month follow-up randomized pilot study. Quintessence Int. 2010 Feb;41(2):125-34.
PMID: 20165744
citation: Chambrone D, Pasin IM, Conde MC, Panutti C, Carneiro S, Lima LA. Effect of enamel matrix proteins on the treatment of intrabony defects: a split-mouth randomized controlled trial study. Braz Oral Res. 2007 Jul-Sep;21(3):241-6. doi: 10.1590/s1806-83242007000300009.
PMID: 17710290
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Mariana Ragghianti Zangrando
investigator title: Doctor
mesh term: Periodontitis
mesh term: Chronic Periodontitis