<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/NCT04482127</url>
  </required_header>
  <id_info>
    <org_study_id>PER 632</org_study_id>
    <nct_id>NCT04482127</nct_id>
  </id_info>
  <brief_title>Volumetric Analysis of Alveolar Ridge Contour Using Sub-epithelial Connective Tissue Graft</brief_title>
  <official_title>Post-extraction Volumetric Analysis of Alveolar Ridge Contour Using Subepithelial Connective Tissue Graft in Esthetic Zone: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      This study will monitor the effect of soft tissue augmentation using sub-epithelial&#xD;
      connective tissue graft buccal to extraction sockets in anterior maxilla in thin&#xD;
      dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge&#xD;
      contour and improve the gingival phenotype following atraumatic extraction compared with no&#xD;
      treatment at all in terms of Ridge contour Preservation for future esthetically acceptable&#xD;
      fixed prothesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to assess the alveolar ridge contour after soft tissue augmentation&#xD;
      using sub-epithelial connective tissue graft buccal to fresh extraction sockets in patient&#xD;
      with thin buccal bone, versus atraumatic extraction with no soft tissue augmentation.&#xD;
&#xD;
      Group A: Patients receiving atraumatic extraction with soft tissue augmentation by&#xD;
      sub-epithelial connective tissue graft buccal to extraction sockets.&#xD;
&#xD;
      Group B: Patients receiving normal atraumatic extraction with no soft tissue augmentation&#xD;
&#xD;
      Clinical examination:&#xD;
&#xD;
        -  Evaluation of the patient's general condition of the oral cavity, to make sure it&#xD;
           complies with the criteria required to be enrolled in the study in terms of oral hygiene&#xD;
           and pathological conditions.&#xD;
&#xD;
        -  Evaluation of the buccal bone thickness using CBCT as diagnostic aid. (After CBCT if the&#xD;
           patient was excluded because of thick buccal bone, he/she will be referred for implant&#xD;
           placement)&#xD;
&#xD;
        -  Evaluation of gingival phenotype before extraction using visual technique via&#xD;
           periodontal probe.&#xD;
&#xD;
        -  After patient enrollment, full mouth scaling to be done first and home oral hygiene&#xD;
           measures to be done by patient. At the day of the surgery, immediately before&#xD;
           extraction, an impression will be taken using alginate material and wax molded stock&#xD;
           tray for recording the original ridge contour as the baseline data. casts will be made&#xD;
           with dental extra hard stone.&#xD;
&#xD;
      Surgical procedure:&#xD;
&#xD;
      After administration of local anesthesia, the tooth will be extracted without raising flaps,&#xD;
      as atraumatic as possible without disturbing the papillary tissues. After the extraction of&#xD;
      the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the&#xD;
      marginal and apical regions.&#xD;
&#xD;
      Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested&#xD;
      from palatal tissue by single line incision technique blade will be oriented perpendicular to&#xD;
      the palatal tissue surface. A single incision will be made down to the bone in a horizontal&#xD;
      direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A&#xD;
      partial thickness dissection will then be made within the single incision, leaving an&#xD;
      adequate thickness of the palatal flap intact to minimize the chance of sloughing of the&#xD;
      overlying tissue. Careful manipulation of the graft with tissue forceps will be required and&#xD;
      care must be taken to prevent compression or tearing of the graft.&#xD;
&#xD;
      The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will&#xD;
      be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction&#xD;
      sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal&#xD;
      aspect without using vertical incisions and without flap elevation. Sutures will be used to&#xD;
      stabilize the graft in its desired place.&#xD;
&#xD;
      Pouch II technique:&#xD;
&#xD;
      A SCTG with a minimum thickness of 1.5 mm will be harvested from the palate. Following&#xD;
      extraction, a full-thickness envelope flap will be created between the facial bone plate and&#xD;
      the overlying gingiva. The SCTG will be inserted into the prepared envelope and secured with&#xD;
      resorbable suture material. The apico-coronal dimension of the SCTG will be standardized&#xD;
      throughout all the cases.&#xD;
&#xD;
      Group B will receive atraumatic extraction with no soft tissue augmentation.&#xD;
&#xD;
      (All patients assigned to the study will be referred to receive Prosthesis after treatment.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 12, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 13, 2021</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>Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique (Hürzeler and Weng, 1999) blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.&#xD;
Group B will receive atraumatic extraction with no soft tissue augmentation.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Buccal soft tissue contour</measure>
    <time_frame>12 Months</time_frame>
    <description>Volumetric analysis using pre and post impressions and a digital software (V.Vanhoutte, et al. 2013) (Van Nimwegen, et al 2018). The soft tissue contours of the extraction sites will be assessed quantitatively. Impressions will be taken at 4 time-points, that is, before tooth extraction (baseline, T0) and 3 (T1), 6 (T2), and 12 (T3) months after surgery. Plaster casts will be generated subsequently and digitised with a laser scanner. For the final analyses, CAD software is to be used to match the corresponding follow-up states (T1 to T3) with the baseline state (T0) and evaluate sections at defined positions with standardization of the apico-coronal dimension of SCTG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival Thickness</measure>
    <time_frame>12 Months</time_frame>
    <description>Gingival Thickness (GT) using Anesthetic Needle with a stopper (Paolantonio et al., 2002) will be measure at base line before extraction (T0), and during the follow up periods (T1-T3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interdental Papilla height</measure>
    <time_frame>12 months</time_frame>
    <description>height of papilla fill</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Alveolar Ridge Collapse</condition>
  <arm_group>
    <arm_group_label>SubEpithelial connective graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCTG harvested from palatal tissue by single line incision technique, blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.&#xD;
The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atraumatic extraction</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Extraction with Periotomes and Luxators keeping the buccal plate of bone intact</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SubEpithelial connective graft</intervention_name>
    <description>Connective tissue graft harvested from hard palate, to be placed buccal to extraction sockets in the intervention group</description>
    <arm_group_label>SubEpithelial connective graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults from the age of 18 - 40 years&#xD;
&#xD;
          -  Patients with non-restorable maxillary teeth/tooth indicated for extraction in the&#xD;
             area from 2nd premolar to 2nd premolar&#xD;
&#xD;
          -  Intact gingival tissue with at least 2mm keratinized tissue&#xD;
&#xD;
          -  Buccal bone thickness should be 1mm or less assessed by CBCT before extraction&#xD;
&#xD;
          -  Periodontally healthy patients&#xD;
&#xD;
          -  Patients accepts to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller,&#xD;
             2009).&#xD;
&#xD;
          -  Handicapped and mentally retarded patients.&#xD;
&#xD;
          -  Patients undergoing radiotherapy.&#xD;
&#xD;
          -  Presence of systemic disease that would affect wound healing.&#xD;
&#xD;
          -  Presence of active infection with soft tissue communication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nourhan Gamal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nourhan Gamal</last_name>
    <phone>01064249441</phone>
    <email>Nourhan.moustafa@dentistry.cu.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nourhan Gamal</last_name>
      <phone>01064249441</phone>
      <email>Nourhan.moustafa@dentistry.cu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nourhan Gamal AbdEl-Aziz</investigator_full_name>
    <investigator_title>Masters Student at Cairo University</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock</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/NCT04482127
org study id: PER 632
nct id: NCT04482127
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will monitor the effect of soft tissue augmentation using sub-epithelial
      connective tissue graft buccal to extraction sockets in anterior maxilla in thin
      dento-alveolar phenotype; and will evaluate whether it will enhance the alveolar ridge
      contour and improve the gingival phenotype following atraumatic extraction compared with no
      treatment at all in terms of Ridge contour Preservation for future esthetically acceptable
      fixed prothesis.
The aim of this study is to assess the alveolar ridge contour after soft tissue augmentation
      using sub-epithelial connective tissue graft buccal to fresh extraction sockets in patient
      with thin buccal bone, versus atraumatic extraction with no soft tissue augmentation.

      Group A: Patients receiving atraumatic extraction with soft tissue augmentation by
      sub-epithelial connective tissue graft buccal to extraction sockets.

      Group B: Patients receiving normal atraumatic extraction with no soft tissue augmentation

      Clinical examination:

        -  Evaluation of the patient's general condition of the oral cavity, to make sure it
           complies with the criteria required to be enrolled in the study in terms of oral hygiene
           and pathological conditions.

        -  Evaluation of the buccal bone thickness using CBCT as diagnostic aid. (After CBCT if the
           patient was excluded because of thick buccal bone, he/she will be referred for implant
           placement)

        -  Evaluation of gingival phenotype before extraction using visual technique via
           periodontal probe.

        -  After patient enrollment, full mouth scaling to be done first and home oral hygiene
           measures to be done by patient. At the day of the surgery, immediately before
           extraction, an impression will be taken using alginate material and wax molded stock
           tray for recording the original ridge contour as the baseline data. casts will be made
           with dental extra hard stone.

      Surgical procedure:

      After administration of local anesthesia, the tooth will be extracted without raising flaps,
      as atraumatic as possible without disturbing the papillary tissues. After the extraction of
      the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the
      marginal and apical regions.

      Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested
      from palatal tissue by single line incision technique blade will be oriented perpendicular to
      the palatal tissue surface. A single incision will be made down to the bone in a horizontal
      direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A
      partial thickness dissection will then be made within the single incision, leaving an
      adequate thickness of the palatal flap intact to minimize the chance of sloughing of the
      overlying tissue. Careful manipulation of the graft with tissue forceps will be required and
      care must be taken to prevent compression or tearing of the graft.

      The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will
      be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction
      sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal
      aspect without using vertical incisions and without flap elevation. Sutures will be used to
      stabilize the graft in its desired place.

      Pouch II technique:

      A SCTG with a minimum thickness of 1.5 mm will be harvested from the palate. Following
      extraction, a full-thickness envelope flap will be created between the facial bone plate and
      the overlying gingiva. The SCTG will be inserted into the prepared envelope and secured with
      resorbable suture material. The apico-coronal dimension of the SCTG will be standardized
      throughout all the cases.

      Group B will receive atraumatic extraction with no soft tissue augmentation.

      (All patients assigned to the study will be referred to receive Prosthesis after treatment.)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group A will receive atraumatic extraction and soft tissue augmentation using SCTG harvested from palatal tissue by single line incision technique (Hürzeler and Weng, 1999) blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.
Group B will receive atraumatic extraction with no soft tissue augmentation.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Buccal soft tissue contour
time frame: 12 Months
description: Volumetric analysis using pre and post impressions and a digital software (V.Vanhoutte, et al. 2013) (Van Nimwegen, et al 2018). The soft tissue contours of the extraction sites will be assessed quantitatively. Impressions will be taken at 4 time-points, that is, before tooth extraction (baseline, T0) and 3 (T1), 6 (T2), and 12 (T3) months after surgery. Plaster casts will be generated subsequently and digitised with a laser scanner. For the final analyses, CAD software is to be used to match the corresponding follow-up states (T1 to T3) with the baseline state (T0) and evaluate sections at defined positions with standardization of the apico-coronal dimension of SCTG.
measure: Gingival Thickness
time frame: 12 Months
description: Gingival Thickness (GT) using Anesthetic Needle with a stopper (Paolantonio et al., 2002) will be measure at base line before extraction (T0), and during the follow up periods (T1-T3)
measure: Interdental Papilla height
time frame: 12 months
description: height of papilla fill
arm group label: SubEpithelial connective graft
arm group type: Experimental
description: SCTG harvested from palatal tissue by single line incision technique, blade will be oriented perpendicular to the palatal tissue surface. A single incision will be made down to the bone in a horizontal direction approximately 2 to 3 mm apical to the gingival margin of the maxillary teeth. A partial thickness dissection will then be made within the single incision, leaving an adequate thickness of the palatal flap intact to minimize the chance of sloughing of the overlying tissue. Careful manipulation of the graft with tissue forceps will be required and care must be taken to prevent compression or tearing of the graft.
The fatty tissue (yellow in color) will be eliminated and some contouring of the graft will be done to fit the prepared envelope. The harvested SCTG will be placed at the extraction sites in a supra-periosteal partial dissection (pouch II technique) prepared at the buccal aspect without using vertical incisions and without flap elevation.
arm group label: Atraumatic extraction
arm group type: No Intervention
description: Extraction with Periotomes and Luxators keeping the buccal plate of bone intact
intervention type: Other
intervention name: SubEpithelial connective graft
description: Connective tissue graft harvested from hard palate, to be placed buccal to extraction sockets in the intervention group
arm group label: SubEpithelial connective graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nourhan Gamal
role: Principal Investigator
affiliation: Cairo University
last name: Nourhan Gamal
phone: 01064249441
email: Nourhan.moustafa@dentistry.cu.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nourhan Gamal AbdEl-Aziz
investigator title: Masters Student at Cairo University
mesh term: Shock
sharing ipd: Undecided