xml: <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/NCT05975515</url>
    </required_header>
    <id_info>
      <org_study_id>PER 2612</org_study_id>
      <nct_id>NCT05975515</nct_id>
    </id_info>
    <brief_title>Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft</brief_title>
    <official_title>Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft. A 1-Year Randomized 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>
        Dimensional changes, including the loss of labial soft tissues and midfacial gingival&#xD;
        recession, seem to be inevitable following immediate placement. The clinical relevance of&#xD;
        this study is proposing a treatment modality namely customized healing abutment with&#xD;
        immediate implant placement that is proposed to minimize and control midfacial gingival&#xD;
        recession and support buccal soft tissue contour, and maintain long term stability of these&#xD;
        tissue, which might enhance the esthetics&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Tooth extraction is followed by ridge alteration and soft tissue collapse and recession.&#xD;
        Different strategies were proposed to limit this collapse however, the ability of these&#xD;
        techniques to mimic the original soft tissue level and to maintain long term stability is&#xD;
        unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of&#xD;
        immediate implant placement is a treatment modality to improve esthetics by maintaining the&#xD;
        soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using&#xD;
        connective tissue grafts has been suggested to enhance and maintain soft tissue stability,&#xD;
        however, the effect of the combined procedures for maintenance of the soft tissue morphology&#xD;
        compared to customized healing abutments alone remains unclear (Atieh et al, 2019).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 13, 2022</start_date>
    <completion_date type="Actual">May 30, 2023</completion_date>
    <primary_completion_date type="Actual">April 30, 2023</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>Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mid facial recession</measure>
      <time_frame>12 months</time_frame>
      <description>will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bucco-palatal bone width</measure>
      <time_frame>12 months</time_frame>
      <description>Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volumetric analysis of buccal contour</measure>
      <time_frame>12 months</time_frame>
      <description>To evaluate tissue volume changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin, at 3, 6 and 12 months and will be compared to the presurgical scanned casts</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">39</enrollment>
    <condition>Customized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant Placement</condition>
    <arm_group>
      <arm_group_label>immediate implant placement with bone grafts till crest</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>immediate implant placement with customized healing abutment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 2 (intervention 1 group): immediate implant placement with customized healing abutment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>immediate implant placement with CTG and customized healing abutment.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 3 (intervention 2 group): immediate implant placement with CTG and customized healing abutment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Connective tissue graft /Bone graft/ Customized HA</intervention_name>
      <description>Soft tissue management and augmentation</description>
      <arm_group_label>immediate implant placement with CTG and customized healing abutment.</arm_group_label>
      <arm_group_label>immediate implant placement with bone grafts till crest</arm_group_label>
      <arm_group_label>immediate implant placement with customized healing abutment</arm_group_label>
      <other_name>Customized Healing abutment</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient-related criteria:&#xD;
  &#xD;
                 -  Adults at or above the age of 18.&#xD;
  &#xD;
                 -  Non-restorable maxillary anterior or premolar tooth requiring extraction and&#xD;
                    needed an implant placing therapy.&#xD;
  &#xD;
                 -  The failing tooth will have adjacent and opposing natural teeth.&#xD;
  &#xD;
                 -  Sufficient mesial-distal and interocclusal space for placement of the implant and&#xD;
                    definitive restoration.&#xD;
  &#xD;
                 -  Able to tolerate surgical periodontal procedures.&#xD;
  &#xD;
                 -  Good oral hygiene.&#xD;
  &#xD;
                 -  Compliance with the maintenance program.&#xD;
  &#xD;
                 -  Provide informed consent.&#xD;
  &#xD;
                 -  Accepts the one-year follow-up period.&#xD;
  &#xD;
          Teeth related criteria:&#xD;
  &#xD;
            -  Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.&#xD;
  &#xD;
            -  Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.&#xD;
  &#xD;
            -  Sufficient apical bone to place an immediate implant with minimum primary stability of&#xD;
               30Ncm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with periodontal diseases.&#xD;
  &#xD;
            -  Current or previous smokers.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Patients with medical conditions that would compromise the surgical procedures;&#xD;
               uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of&#xD;
               osteoporosis.&#xD;
  &#xD;
            -  Patients with active infection related at the site of implant/bone graft placement.&#xD;
  &#xD;
            -  Patients with parafunctional habits&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>IDCE</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Ahmed Aboulfettouh</investigator_full_name>
      <investigator_title>Dr. Ahmed Ibrahim AboulFettouh</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975515
  org study id: PER 2612
  nct id: NCT05975515
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Dimensional changes, including the loss of labial soft tissues and midfacial gingival
        recession, seem to be inevitable following immediate placement. The clinical relevance of
        this study is proposing a treatment modality namely customized healing abutment with
        immediate implant placement that is proposed to minimize and control midfacial gingival
        recession and support buccal soft tissue contour, and maintain long term stability of these
        tissue, which might enhance the esthetics
  Tooth extraction is followed by ridge alteration and soft tissue collapse and recession.
        Different strategies were proposed to limit this collapse however, the ability of these
        techniques to mimic the original soft tissue level and to maintain long term stability is
        unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of
        immediate implant placement is a treatment modality to improve esthetics by maintaining the
        soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using
        connective tissue grafts has been suggested to enhance and maintain soft tissue stability,
        however, the effect of the combined procedures for maintenance of the soft tissue morphology
        compared to customized healing abutments alone remains unclear (Atieh et al, 2019).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled clinical trial, parallel groups, three-arm, superiority trial with 1:1:1 allocation ratio.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Mid facial recession
  time frame: 12 months
  description: will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.
  measure: Bucco-palatal bone width
  time frame: 12 months
  description: Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland.
  measure: Volumetric analysis of buccal contour
  time frame: 12 months
  description: To evaluate tissue volume changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin, at 3, 6 and 12 months and will be compared to the presurgical scanned casts
  arm group label: immediate implant placement with bone grafts till crest
  arm group type: Active Comparator
  description: Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment.
  arm group label: immediate implant placement with customized healing abutment
  arm group type: Experimental
  description: Group 2 (intervention 1 group): immediate implant placement with customized healing abutment
  arm group label: immediate implant placement with CTG and customized healing abutment.
  arm group type: Experimental
  description: Group 3 (intervention 2 group): immediate implant placement with CTG and customized healing abutment.
  intervention type: Procedure
  intervention name: Connective tissue graft /Bone graft/ Customized HA
  description: Soft tissue management and augmentation
  arm group label: immediate implant placement with CTG and customized healing abutment.
  arm group label: immediate implant placement with bone grafts till crest
  arm group label: immediate implant placement with customized healing abutment
  other name: Customized Healing abutment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Ahmed Aboulfettouh
  investigator title: Dr. Ahmed Ibrahim AboulFettouh