<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/NCT03251001</url>
  </required_header>
  <id_info>
    <org_study_id>BauruSchoolDentistryADM</org_study_id>
    <nct_id>NCT03251001</nct_id>
  </id_info>
  <brief_title>Acellular Dermal Matrix Allograft Versus Free Gingival Graft</brief_title>
  <official_title>Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial</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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and&#xD;
      histological results of acellular dermal matrix allograft (ADM) compared to autogenous free&#xD;
      gingival graft (FGG)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 1999</start_date>
  <completion_date type="Actual">December 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Split-mouth design. One side of mouth was test group, other side was control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>keratinized tissue width</measure>
    <time_frame>18 years</time_frame>
    <description>Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is &gt; 5mm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>18 years</time_frame>
    <description>Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if &lt; 2mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attachment level</measure>
    <time_frame>18 years</time_frame>
    <description>Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if &lt; 2mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recession depth</measure>
    <time_frame>18 years</time_frame>
    <description>Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Gingiva Atrophy</condition>
  <condition>Gingivitis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sites receiving a free gingival graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Device - Acellular dermal matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sites receiving acellular dermal matrix</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acellular Dermal Matrix</intervention_name>
    <description>Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate</description>
    <arm_group_label>Device - Acellular dermal matrix</arm_group_label>
    <other_name>allograft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  absence or deficiency of keratinized tissue (&lt; 1mm) in two homologous contralateral&#xD;
             sites of inferior premolars&#xD;
&#xD;
          -  Miller Class I or II gingival recession&#xD;
&#xD;
          -  Absence of radiographic bone loss&#xD;
&#xD;
          -  Vital tooth or with adequate endodontic treatment&#xD;
&#xD;
          -  Root surfaces without caries&#xD;
&#xD;
          -  Good oral hygiene (plaque index &lt; 20%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic to penicillin&#xD;
&#xD;
          -  Presenting systemic disease that impede surgical procedure&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Intake of calcium channel blockers that cause gingival augmentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bauru School of Dentistry</name>
      <address>
        <city>Bauru</city>
        <state>Sao Paulo</state>
        <zip>17012-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.</citation>
    <PMID>15974840</PMID>
  </reference>
  <reference>
    <citation>Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.</citation>
    <PMID>26681852</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Carla Andreotti Damante</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>gingiva</keyword>
  <keyword>keratinized mucosa</keyword>
  <keyword>gingival graft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03251001
org study id: BauruSchoolDentistryADM
nct id: NCT03251001
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and
      histological results of acellular dermal matrix allograft (ADM) compared to autogenous free
      gingival graft (FGG)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Split-mouth design. One side of mouth was test group, other side was control group.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All clinical parameters were evaluated by a calibrated examiner (intraclass correlation coefficient = 0.98) blind to test and control groups.
measure: keratinized tissue width
time frame: 18 years
description: Distance from gingival margin to mucogingival junction, measured with a periodontal probe in mm. Ideal if mucosa width is > 5mm.
measure: Probing depth
time frame: 18 years
description: Distance from gingival margin to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
measure: Attachment level
time frame: 18 years
description: Distance from cemento-enamel junction to bottom of gingival sulcus, measured with a periodontal probe. Ideal if < 2mm.
measure: Recession depth
time frame: 18 years
description: Distance from cemento-enamel junction to gingival margin, measured with a periodontal probe. Ideal if = 0mm.
arm group label: Control
arm group type: Active Comparator
description: Sites receiving a free gingival graft
arm group label: Device - Acellular dermal matrix
arm group type: Experimental
description: Sites receiving acellular dermal matrix
intervention type: Procedure
intervention name: Control
description: Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva
arm group label: Control
intervention type: Device
intervention name: Acellular Dermal Matrix
description: Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
arm group label: Device - Acellular dermal matrix
other name: allograft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
citation: Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.
PMID: 15974840
citation: Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
PMID: 26681852
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Carla Andreotti Damante
investigator title: Associate professor
mesh term: Gingivitis
mesh term: Gingival Recession
sharing ipd: Undecided