<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/NCT04415619</url>
  </required_header>
  <id_info>
    <org_study_id>Buccal pad of fat free tissue</org_study_id>
    <nct_id>NCT04415619</nct_id>
  </id_info>
  <brief_title>Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement</brief_title>
  <official_title>Evaluation of Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement in the Maxillary Posterior Area</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Implants placed immediately after tooth extraction usually present challenges in obtaining&#xD;
      soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently&#xD;
      adverse effect on the success rate of the implant due to lack of primary soft tissue closure&#xD;
      over the implant.&#xD;
&#xD;
      Different surgical methods have been described to achieve primary soft tissue closure in&#xD;
      maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal&#xD;
      pad of fat can solve this soft tissue coverage problem with minimal complications and high&#xD;
      success rate of the placed implants.The objective of this study is to evaluate the use of&#xD;
      buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten patients will be selected randomly from the outpatient clinic, Alexandria University&#xD;
      seeking for an immediate implant placement. The sample will be selected to match the&#xD;
      inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial&#xD;
      Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth&#xD;
      extraction, placement of an immediate implant, bone grafting material and autologous soft&#xD;
      tissue graft from the buccal pad of fat. Patients will be assessed clinically and&#xD;
      radiographically to evaluate bone and soft tissue measurements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 13, 2020</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>A group of 10 patients will receive immediate implant placement with buccal pad of fat coverage</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.</measure>
    <time_frame>6 months</time_frame>
    <description>Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using:&#xD;
a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.</measure>
    <time_frame>6 months</time_frame>
    <description>Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluation of soft tissue healing&#xD;
At week 1, week4 and at 6 months:&#xD;
Presence/absence of postoperative complications will be evaluated, including:&#xD;
Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area</measure>
    <time_frame>6 months</time_frame>
    <description>Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.</measure>
    <time_frame>6 months</time_frame>
    <description>After 3 months then at 6 months Cone Beam CT will be requested in order to measure:&#xD;
Bone density.&#xD;
Amount of bone buccally and palatally to the implant.&#xD;
Marginal bone loss.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Dental Implant</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 patients will have immediate implant placement with buccal pad of fat free tissue</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Xenograft bone substitute (Osteo-biol)</intervention_name>
    <description>Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Implant(Superline®,DentiumCoTM)</other_name>
    <other_name>Osstell(ISQ®)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age between 20-45 years with no gender predilection.&#xD;
&#xD;
          -  Patients with non-restorable maxillary posterior tooth which need to be extracted&#xD;
             (premolar -molar region).&#xD;
&#xD;
          -  Patients with good oral hygiene.&#xD;
&#xD;
          -  Bony defects more than 2 mm during implant placement treated by bone substitute.&#xD;
&#xD;
          -  Patients fully capable to comply with the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any systemic disease affecting bone quality as uncontrolled diabetes.&#xD;
&#xD;
          -  Heavy smokers (more than 20 cigarettes per day).&#xD;
&#xD;
          -  Sites with acute oral infection.&#xD;
&#xD;
          -  Pregnant and lactating patients.&#xD;
&#xD;
          -  Untreated periodontal disease.&#xD;
&#xD;
          -  Previous chemotherapy or irradiation of the head and neck.&#xD;
&#xD;
          -  Inadequate interocclusal space.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lobna Elwan, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nagy El Prince, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed O. Swedan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dina Y. Attia, MSc</last_name>
    <phone>+01017510444</phone>
    <email>dina.youssef29@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lobna Elwan, BSc</last_name>
    <email>lobnaelwan@gmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Penarrocha-Diago M, Alonso-Gonzalez R, Aloy-Prosper A, Penarrocha-Oltra D, Camacho F, Penarrocha-Diago M. Use of buccal fat pad to repair post-extraction peri-implant bone defects in the posterior maxilla. A preliminary prospective study. Med Oral Patol Oral Cir Bucal. 2015 Nov 1;20(6):e699-706. doi: 10.4317/medoral.20212.</citation>
    <PMID>26241450</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Dina Youssef Attia</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>Implant</keyword>
  <keyword>Buccal fat pad</keyword>
  <keyword>Immediate</keyword>
  <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/NCT04415619
org study id: Buccal pad of fat free tissue
nct id: NCT04415619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Implants placed immediately after tooth extraction usually present challenges in obtaining
      soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently
      adverse effect on the success rate of the implant due to lack of primary soft tissue closure
      over the implant.

      Different surgical methods have been described to achieve primary soft tissue closure in
      maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal
      pad of fat can solve this soft tissue coverage problem with minimal complications and high
      success rate of the placed implants.The objective of this study is to evaluate the use of
      buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.
Ten patients will be selected randomly from the outpatient clinic, Alexandria University
      seeking for an immediate implant placement. The sample will be selected to match the
      inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial
      Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth
      extraction, placement of an immediate implant, bone grafting material and autologous soft
      tissue graft from the buccal pad of fat. Patients will be assessed clinically and
      radiographically to evaluate bone and soft tissue measurements.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A group of 10 patients will receive immediate implant placement with buccal pad of fat coverage
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate postoperative pain when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
time frame: 6 months
description: Postoperative pain will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using:
a 10-point Visual Analogue Scale (VAS) (17) from 0 to 10 (0 no pain, to 10 severe pain).
measure: Evaluate swelling when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
time frame: 6 months
description: Postoperative swelling will be recorded by each patient after 2, 6, and 12 hours postoperatively, then daily for the first week using a 10-point scale with 4 parameters will be used: none (no swelling), light (intraoral, localized to the treated area), moderate (extraoral swelling localized to the treated area), and severe (extraoral swelling extending beyond the treated area)
measure: Evaluate soft tissue healing when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
time frame: 6 months
description: Evaluation of soft tissue healing
At week 1, week4 and at 6 months:
Presence/absence of postoperative complications will be evaluated, including:
Bleeding, hematoma, wound dehiscence, local infection, partial flap necrosis, excessive granulation tissue or vestibular obliteration, edema, facial asymmetry and mouth opening limitation.
measure: Evaluate implant stability when using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area
time frame: 6 months
description: Implant stability will be measured by implant stability meter (OsstellTM), immediately postoperative and after 6 months.
measure: Radiographic evaluation for using the buccal pad of fat free tissue graft for primary soft tissue coverage with immediate implant placement in the posterior maxillary area.
time frame: 6 months
description: After 3 months then at 6 months Cone Beam CT will be requested in order to measure:
Bone density.
Amount of bone buccally and palatally to the implant.
Marginal bone loss.
arm group label: Intervention group
arm group type: Experimental
description: 10 patients will have immediate implant placement with buccal pad of fat free tissue
intervention type: Procedure
intervention name: Xenograft bone substitute (Osteo-biol)
description: Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
arm group label: Intervention group
other name: Implant(Superline®,DentiumCoTM)
other name: Osstell(ISQ®)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Lobna Elwan, BSc
role: Principal Investigator
affiliation: Alexandria University
last name: Nagy El Prince, PhD
role: Study Director
affiliation: Alexandria University
last name: Ahmed O. Swedan, PhD
role: Study Director
affiliation: Alexandria University
last name: Dina Y. Attia, MSc
phone: +01017510444
email: dina.youssef29@gmail.com
last name: Lobna Elwan, BSc
email: lobnaelwan@gmail.com
citation: Penarrocha-Diago M, Alonso-Gonzalez R, Aloy-Prosper A, Penarrocha-Oltra D, Camacho F, Penarrocha-Diago M. Use of buccal fat pad to repair post-extraction peri-implant bone defects in the posterior maxilla. A preliminary prospective study. Med Oral Patol Oral Cir Bucal. 2015 Nov 1;20(6):e699-706. doi: 10.4317/medoral.20212.
PMID: 26241450
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Dina Youssef Attia
investigator title: Assistant lecturer
sharing ipd: Undecided