<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/NCT04410614</url>
  </required_header>
  <id_info>
    <org_study_id>21052020</org_study_id>
    <nct_id>NCT04410614</nct_id>
  </id_info>
  <brief_title>Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites</brief_title>
  <official_title>Dimensional Changes of Free Epithelial Graft at Teeth and Implant Sites: A Prospective Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      For the management of peridontal and peri-implant conditions, free epithelial grafts have&#xD;
      been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing&#xD;
      confort during brushing and reducing the level of inflammation. Nevertheless, these are&#xD;
      subjected to dimensional changes that may jeopardise the final outcome of providing&#xD;
      sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim&#xD;
      at shedding light on the dimensional changes and the variables affecting these changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Teeth and implants receiving free epithelial grafts harvested from the palate</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in keratinized mucosa</measure>
    <time_frame>3 weeks, 3 months, 6 months follow-up</time_frame>
    <description>Area of keratinized mucosa gain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factor 1 affecting the dimensional changes</measure>
    <time_frame>3 weeks, 3 months, 6 months</time_frame>
    <description>Avascular area exposed to the graft (implant/tooth surface)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factor 2 affecting the dimensional changes</measure>
    <time_frame>3 weeks, 3 months, 6 months</time_frame>
    <description>Thickness in mm of the graft</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factor 3 affecting the dimensional changes</measure>
    <time_frame>3 weeks, 3 months, 6 months</time_frame>
    <description>Thickness in mm of the recipient connective tissue</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Keratinized Mucosa</condition>
  <arm_group>
    <arm_group_label>Free epithelial graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Free epithelial graft at implant and teeth sites to increase the band of keratinized mucosa</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Free epithelial (gingival) graft</intervention_name>
    <description>1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa</description>
    <arm_group_label>Free epithelial graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in need of keratinized mucosa to improve the periodontal and peri-implant&#xD;
             condition&#xD;
&#xD;
          -  With no uncontrolled disease&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled diseases and conditions&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Patients with sufficient keratinized mucosa&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro de Implantologia Cirugia Oral y Maxilofacial</name>
      <address>
        <city>Badajoz</city>
        <zip>06011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.</citation>
    <PMID>30461016</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>September 9, 2021</last_update_submitted>
  <last_update_submitted_qc>September 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain</investigator_affiliation>
    <investigator_full_name>Alberto Monje</investigator_full_name>
    <investigator_title>Head of Division of Periodontology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410614
org study id: 21052020
nct id: NCT04410614
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
For the management of peridontal and peri-implant conditions, free epithelial grafts have
      been proposed to provide a sufficient band of keratinized mucosa with the goal of enhancing
      confort during brushing and reducing the level of inflammation. Nevertheless, these are
      subjected to dimensional changes that may jeopardise the final outcome of providing
      sufficient keratinized mucosa to teeth and implants. Hence, this prospective study will aim
      at shedding light on the dimensional changes and the variables affecting these changes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Teeth and implants receiving free epithelial grafts harvested from the palate
primary purpose: Treatment
masking: None (Open Label)
measure: Change in keratinized mucosa
time frame: 3 weeks, 3 months, 6 months follow-up
description: Area of keratinized mucosa gain
measure: Factor 1 affecting the dimensional changes
time frame: 3 weeks, 3 months, 6 months
description: Avascular area exposed to the graft (implant/tooth surface)
measure: Factor 2 affecting the dimensional changes
time frame: 3 weeks, 3 months, 6 months
description: Thickness in mm of the graft
measure: Factor 3 affecting the dimensional changes
time frame: 3 weeks, 3 months, 6 months
description: Thickness in mm of the recipient connective tissue
arm group label: Free epithelial graft
arm group type: Experimental
description: Free epithelial graft at implant and teeth sites to increase the band of keratinized mucosa
intervention type: Procedure
intervention name: Free epithelial (gingival) graft
description: 1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa
arm group label: Free epithelial graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
citation: Monje A, Blasi G. Significance of keratinized mucosa/gingiva on peri-implant and adjacent periodontal conditions in erratic maintenance compliers. J Periodontol. 2019 May;90(5):445-453. doi: 10.1002/JPER.18-0471. Epub 2018 Dec 7.
PMID: 30461016
responsible party type: Principal Investigator
investigator affiliation: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
investigator full name: Alberto Monje
investigator title: Head of Division of Periodontology
sharing ipd: No