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/NCT05987930</url>
    </required_header>
    <id_info>
      <org_study_id>1611</org_study_id>
      <nct_id>NCT05987930</nct_id>
    </id_info>
    <brief_title>Bone Lid Technique Versus Standard Technique for Treatment of Mandibular Lesions</brief_title>
    <official_title>Lecturer of Oral and Maxillofacial Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Twenty patients with benign mandibular lesion will be included in this study. the patient&#xD;
        will be divided randomly (10 patients each group). Group I the lesion will be treated using&#xD;
        bone lid technique. Group II the lesion will be treated using the standard technique. The&#xD;
        patients will be received, clinically and radiologically examined, and managed at the Oral&#xD;
        and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.&#xD;
  &#xD;
        The patients will be evaluated clinically to evaluate healing and radiographically using cone&#xD;
        beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six&#xD;
        months later&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid&#xD;
        technique performed using a piezoelectric device versus the traditional technique in patients&#xD;
        requiring excision of the mandibular bony lesions&#xD;
  &#xD;
        Materials &amp; Methods: Twenty patients with mandibular lesion will be included in this study.&#xD;
        the patient will be divided randomly (10 patients each group). Group I the lesion will be&#xD;
        treated using bone lid technique. Group II the lesion will be treated using the standard&#xD;
        technique. The patients will be received, clinically and radiologically examined, and managed&#xD;
        at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.&#xD;
  &#xD;
        Preoperative evaluation: The patients will be evaluated clinically and radiographically using&#xD;
        Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.&#xD;
  &#xD;
        Surgical procedure: A full thickness flap will be elevated in both groups to achieve access&#xD;
        to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond&#xD;
        the actual extension of lesion in radiograph using piezoelectric device to secure a latter&#xD;
        repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an&#xD;
        internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in&#xD;
        saline. After excision of the lesion, the bony lid will be repositioned to its original&#xD;
        position and fixed to the bone with an absorbable suture.&#xD;
  &#xD;
        In group II the bone will be removed buccally using surgical bur then the lesion is removed.&#xD;
        Finally, the flap will be sutured in both groups.&#xD;
  &#xD;
        Postoperative evaluation: The patients will be evaluated clinically regarding healing,&#xD;
        presence of infection, inflammation, necrosis, or bone exposure each week for one month then&#xD;
        monthly for six months.&#xD;
  &#xD;
        Radiographically, (CBCT) scan six months later to evaluate Healing and integration of the&#xD;
        repositioned bone lid, any signs of recurrence in the case of cysts, and filling of the bone&#xD;
        defect bone healing and volume of the defect.&#xD;
  &#xD;
        All selected cases of both groups b were went for CBCT scan using fixed exposure parameters&#xD;
        (Kv, mA) and the same field of view prior surgery and 6 months post-surgical using the same&#xD;
        axial slicing to evaluate the following&#xD;
  &#xD;
          1. Cyst area in coronal view for posterior region and sagittal view for anterior region&#xD;
  &#xD;
          2. Evaluating lesion location by making perpendicular line from alveolar crest on the&#xD;
             occlusal plane and measuring the distance from alveolar crest to the lesion using&#xD;
             (Coronal view posterior, sagittal anterior).&#xD;
  &#xD;
        3- recurrence of lesion , integration of buccal cortex 4- bone density&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">December 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>degree of pain evaluated clinically in both groups</measure>
      <time_frame>one-two weeks</time_frame>
      <description>using visual analogue scale:0 represent no pain and 10 represents the highest level of pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>soft tissue healing evaluated clinically in both groups</measure>
      <time_frame>one week</time_frame>
      <description>presence of dehiscence and exposure of bone or not</description>
    </primary_outcome>
    <primary_outcome>
      <measure>infection evaluated clinically in both groups</measure>
      <time_frame>one week-one month</time_frame>
      <description>presence of signs of infection or not</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cyst area calculation radiographically in both groups</measure>
      <time_frame>six months</time_frame>
      <description>using CBCT to measure the area in mm2</description>
    </primary_outcome>
    <primary_outcome>
      <measure>measuring the distance between the lesion and alveolar crest in both groups</measure>
      <time_frame>six months</time_frame>
      <description>making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>density of bone calculated radiographically in both groups</measure>
      <time_frame>six months</time_frame>
      <description>CBCT to measure density (D1&gt; 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>inflammation clinically in both groups</measure>
      <time_frame>one week</time_frame>
      <description>0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>integration of buccal cortex radigraphically in both groups</measure>
      <time_frame>six months</time_frame>
      <description>presence of radiolucency around of buccal cortex or not</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Mandible Cyst</condition>
    <condition>Mandible Tumor</condition>
    <condition>Mandibular Diseases</condition>
    <arm_group>
      <arm_group_label>bone lid technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ten patients with mandibular benign lesions which were treated with bone lid technique to enucleate the lesion using piezo-electric device to allow removal of buccal bone cortex with preservation of it to have access to lesion then reposition of bone lid in its place</description>
    </arm_group>
    <arm_group>
      <arm_group_label>standard technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>bone lid technique</intervention_name>
      <description>group I ten patients with mandibular lesion will be undergo excision of lesion using bone lid technique with piezo-electric device then reposition of buccal bone cortex</description>
      <arm_group_label>bone lid technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>standard technique</intervention_name>
      <description>group II ten patients with mandibular lesion will be undergo excision of lesion using surgical bur to remove buccal cortex to get access to lesion</description>
      <arm_group_label>standard technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          age ≥ 6 years&#xD;
  &#xD;
            -  presence of bony lesion (cysts, benign tumors, odontoma) located in mandibular region,&#xD;
  &#xD;
            -  the existence of a normal residual buccal cortical plate with the adequate thickness&#xD;
               (≥1 mm) at least at the periphery of buccal cortical plate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • patients taking medications that affect bone metabolism,&#xD;
  &#xD;
                 -  patients underwent head and neck radiotherapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>mona s sheta</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tanta University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of Dentistry, Tanta University</name>
        <address>
          <city>Tanta</city>
          <zip>3111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>mona samy sheta</investigator_full_name>
      <investigator_title>Lecturer of Oral and Maxillofacial Surgery Department</investigator_title>
    </responsible_party>
    <keyword>mandibular lesions</keyword>
    <keyword>bone lid technique</keyword>
    <keyword>standard technique</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mandibular Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT05987930
  org study id: 1611
  nct id: NCT05987930
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Twenty patients with benign mandibular lesion will be included in this study. the patient
        will be divided randomly (10 patients each group). Group I the lesion will be treated using
        bone lid technique. Group II the lesion will be treated using the standard technique. The
        patients will be received, clinically and radiologically examined, and managed at the Oral
        and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
  
        The patients will be evaluated clinically to evaluate healing and radiographically using cone
        beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six
        months later
  Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid
        technique performed using a piezoelectric device versus the traditional technique in patients
        requiring excision of the mandibular bony lesions
  
        Materials & Methods: Twenty patients with mandibular lesion will be included in this study.
        the patient will be divided randomly (10 patients each group). Group I the lesion will be
        treated using bone lid technique. Group II the lesion will be treated using the standard
        technique. The patients will be received, clinically and radiologically examined, and managed
        at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
  
        Preoperative evaluation: The patients will be evaluated clinically and radiographically using
        Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.
  
        Surgical procedure: A full thickness flap will be elevated in both groups to achieve access
        to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond
        the actual extension of lesion in radiograph using piezoelectric device to secure a latter
        repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an
        internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in
        saline. After excision of the lesion, the bony lid will be repositioned to its original
        position and fixed to the bone with an absorbable suture.
  
        In group II the bone will be removed buccally using surgical bur then the lesion is removed.
        Finally, the flap will be sutured in both groups.
  
        Postoperative evaluation: The patients will be evaluated clinically regarding healing,
        presence of infection, inflammation, necrosis, or bone exposure each week for one month then
        monthly for six months.
  
        Radiographically, (CBCT) scan six months later to evaluate Healing and integration of the
        repositioned bone lid, any signs of recurrence in the case of cysts, and filling of the bone
        defect bone healing and volume of the defect.
  
        All selected cases of both groups b were went for CBCT scan using fixed exposure parameters
        (Kv, mA) and the same field of view prior surgery and 6 months post-surgical using the same
        axial slicing to evaluate the following
  
          1. Cyst area in coronal view for posterior region and sagittal view for anterior region
  
          2. Evaluating lesion location by making perpendicular line from alveolar crest on the
             occlusal plane and measuring the distance from alveolar crest to the lesion using
             (Coronal view posterior, sagittal anterior).
  
        3- recurrence of lesion , integration of buccal cortex 4- bone density
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: degree of pain evaluated clinically in both groups
  time frame: one-two weeks
  description: using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
  measure: soft tissue healing evaluated clinically in both groups
  time frame: one week
  description: presence of dehiscence and exposure of bone or not
  measure: infection evaluated clinically in both groups
  time frame: one week-one month
  description: presence of signs of infection or not
  measure: cyst area calculation radiographically in both groups
  time frame: six months
  description: using CBCT to measure the area in mm2
  measure: measuring the distance between the lesion and alveolar crest in both groups
  time frame: six months
  description: making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.
  measure: density of bone calculated radiographically in both groups
  time frame: six months
  description: CBCT to measure density (D1> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield
  measure: inflammation clinically in both groups
  time frame: one week
  description: 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
  measure: integration of buccal cortex radigraphically in both groups
  time frame: six months
  description: presence of radiolucency around of buccal cortex or not
  arm group label: bone lid technique
  arm group type: Experimental
  description: ten patients with mandibular benign lesions which were treated with bone lid technique to enucleate the lesion using piezo-electric device to allow removal of buccal bone cortex with preservation of it to have access to lesion then reposition of bone lid in its place
  arm group label: standard technique
  arm group type: Experimental
  description: ten patients with mandibular benign lesions in which the buccal cortex was removed by gridding using surgical rotary bur to allow enucleation of lesion
  intervention type: Device
  intervention name: bone lid technique
  description: group I ten patients with mandibular lesion will be undergo excision of lesion using bone lid technique with piezo-electric device then reposition of buccal bone cortex
  arm group label: bone lid technique
  intervention type: Device
  intervention name: standard technique
  description: group II ten patients with mandibular lesion will be undergo excision of lesion using surgical bur to remove buccal cortex to get access to lesion
  arm group label: standard technique
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: mona s sheta
  role: Principal Investigator
  affiliation: Tanta University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: mona samy sheta
  investigator title: Lecturer of Oral and Maxillofacial Surgery Department
  mesh term: Mandibular Diseases