<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/NCT04421144</url>
  </required_header>
  <id_info>
    <org_study_id>Dr.Zain protocol</org_study_id>
    <nct_id>NCT04421144</nct_id>
  </id_info>
  <brief_title>Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries</brief_title>
  <official_title>Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries</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>
      In this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and&#xD;
      customized titanium plates to guide all osteotomies and fixation of both arches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention:&#xD;
&#xD;
        1. Diagnostic procedure:&#xD;
&#xD;
           All Patients will be selected according to inclusion and exclusion criteria &amp;&#xD;
           Comprehensive clinical examination and understanding of patients' chief complains and&#xD;
           needs will be carried out.&#xD;
&#xD;
           Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion).&#xD;
&#xD;
           Alginate Impressions of upper &amp; lower jaws will be taken for acquiring diagnostic dental&#xD;
           casts.&#xD;
&#xD;
           A heat-cured acrylic resin stent will be constructed on the stone model. Using the&#xD;
           stent, a radiographic stent will be constructed for imaging and planning procedures.&#xD;
&#xD;
           Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients&#xD;
           will be referred to an orthodontist for presurgical phase of orthodontic treatment for&#xD;
           decompensation and to attain stable occlusion in three points in the surgery.&#xD;
&#xD;
        2. Planning procedure:&#xD;
&#xD;
           All planning procedures are carried out by MZ and under the supervision of AH and MH.&#xD;
&#xD;
           Computer-aided planning &amp; MCROS design for all patients: All planning will be done using&#xD;
           specialized software .&#xD;
&#xD;
           One virtual 3D anatomic model of the patient will be constructed through thresholding &amp;&#xD;
           image fusion.&#xD;
&#xD;
           Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to&#xD;
           the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of&#xD;
           the sagittal split of the mandible will be performed and the mandible position adjusted&#xD;
           according to the bite registered.&#xD;
&#xD;
           After settling on the optimum virtual plan, designing of the cutting guides and titanium&#xD;
           plates will then be started.&#xD;
&#xD;
        3. Intra-operative procedures:&#xD;
&#xD;
           The surgical procedures will be carried out by MZ under the supervisor of AH in the Oral&#xD;
           &amp; Maxillofacial operating floor on the 8th floor of the faculty of Oral &amp; Dental&#xD;
           Medicine new building.&#xD;
&#xD;
           Scrubbing and draping of the patient will be carried out in a standard fashion according&#xD;
           to Anon 2006.&#xD;
&#xD;
           Local anaesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along&#xD;
           the incision lines for hemostasis.&#xD;
&#xD;
           Access through a vestibular intraoral incision for maxilla &amp; Sagittal split incision for&#xD;
           mandible will be carried out. Dissection and reflection to reach the bone will be&#xD;
           carried out.&#xD;
&#xD;
           Le Fort I Maxillary &amp; Bilateral Sagittal split mandibular osteotomies will be carried&#xD;
           out using the osteotomy cutting guides.&#xD;
&#xD;
           Complete mobilization of maxillary and mandibular segments. Reposition and fixation of&#xD;
           the maxillary &amp; mandibular segments using customized titanium plates.&#xD;
&#xD;
           The incisions will be closed with continuous mattress resorbable sutures .&#xD;
&#xD;
        4. Post-operative care:&#xD;
&#xD;
           Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin&#xD;
           / Clavulanic acid 625 mg every 8 hours) for 5 days Patients will start analgesics&#xD;
           (NSAIDs every 6 hours) for 3 days Mouthwash (Chlorhexidine 0.12%) will be prescribed for&#xD;
           2 more weeks.&#xD;
&#xD;
        5. Criteria for discontinuing or modifying intervention:&#xD;
&#xD;
             -  Difficulty with the use of cutting guides and customized titanium plates.&#xD;
&#xD;
             -  Inaccurate translation of the surgical plan.&#xD;
&#xD;
        6. Strategies to improve adherence to intervention:&#xD;
&#xD;
           Postoperative orthodontic treatment is necessary after the operation to obtain the final&#xD;
           stable occlusion.&#xD;
&#xD;
        7. Concomitant care:&#xD;
&#xD;
           Not needed.&#xD;
&#xD;
        8. Follow up &amp; Evaluation:&#xD;
&#xD;
      Post-operative treatment will start immediately postoperative (4 hours). The patients will be&#xD;
      scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.&#xD;
&#xD;
      Within the first week postoperatively CBCT using same parameters will be ordered to calculate&#xD;
      the difference between surgical plan and actual outcome will be evaluated.&#xD;
&#xD;
      Patient will be referred back to the orthodontist to receive his postsurgical orthodontics&#xD;
      4-6 weeks postoperatively.&#xD;
&#xD;
      The technique will be evaluated by applying hard tissue parameters to compare the virtual&#xD;
      orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image&#xD;
      fusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>case series</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of the surgical transfer</measure>
    <time_frame>within first week postoperatively</time_frame>
    <description>Computer software on pre/postoperative CBCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: Visual analog scale (questionnaire)</measure>
    <time_frame>one week postoperative</time_frame>
    <description>Visual analog scale (questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Evaluation of the Accuracy of Transferring the Virtual Planning to the Surgery</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>orthognathic surgery</intervention_name>
    <description>patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.</description>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with dentofacial disharmony and misalignment requiring bimaxillary&#xD;
             orthognathic surgeries.&#xD;
&#xD;
          2. Patients with no signs or symptoms of active TMDs.&#xD;
&#xD;
          3. Highly motivated patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who refused to be included in the research.&#xD;
&#xD;
          2. Patients with systemic diseases that may hinder the normal healing process or render&#xD;
             the patient not fitting for general anaesthesia.&#xD;
&#xD;
          3. Patients with intra-bony lesions or infections that may retard the osteotomy healing.&#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>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohammed Zain</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>CAD/CAM</keyword>
  <keyword>orthognathic surgery</keyword>
  <keyword>virtual planning</keyword>
  <keyword>cutting guides</keyword>
  <keyword>customized titanium plates</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04421144
org study id: Dr.Zain protocol
nct id: NCT04421144
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and
      customized titanium plates to guide all osteotomies and fixation of both arches.
Intervention:

        1. Diagnostic procedure:

           All Patients will be selected according to inclusion and exclusion criteria &
           Comprehensive clinical examination and understanding of patients' chief complains and
           needs will be carried out.

           Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion).

           Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental
           casts.

           A heat-cured acrylic resin stent will be constructed on the stone model. Using the
           stent, a radiographic stent will be constructed for imaging and planning procedures.

           Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients
           will be referred to an orthodontist for presurgical phase of orthodontic treatment for
           decompensation and to attain stable occlusion in three points in the surgery.

        2. Planning procedure:

           All planning procedures are carried out by MZ and under the supervision of AH and MH.

           Computer-aided planning & MCROS design for all patients: All planning will be done using
           specialized software .

           One virtual 3D anatomic model of the patient will be constructed through thresholding &
           image fusion.

           Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to
           the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of
           the sagittal split of the mandible will be performed and the mandible position adjusted
           according to the bite registered.

           After settling on the optimum virtual plan, designing of the cutting guides and titanium
           plates will then be started.

        3. Intra-operative procedures:

           The surgical procedures will be carried out by MZ under the supervisor of AH in the Oral
           & Maxillofacial operating floor on the 8th floor of the faculty of Oral & Dental
           Medicine new building.

           Scrubbing and draping of the patient will be carried out in a standard fashion according
           to Anon 2006.

           Local anaesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along
           the incision lines for hemostasis.

           Access through a vestibular intraoral incision for maxilla & Sagittal split incision for
           mandible will be carried out. Dissection and reflection to reach the bone will be
           carried out.

           Le Fort I Maxillary & Bilateral Sagittal split mandibular osteotomies will be carried
           out using the osteotomy cutting guides.

           Complete mobilization of maxillary and mandibular segments. Reposition and fixation of
           the maxillary & mandibular segments using customized titanium plates.

           The incisions will be closed with continuous mattress resorbable sutures .

        4. Post-operative care:

           Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin
           / Clavulanic acid 625 mg every 8 hours) for 5 days Patients will start analgesics
           (NSAIDs every 6 hours) for 3 days Mouthwash (Chlorhexidine 0.12%) will be prescribed for
           2 more weeks.

        5. Criteria for discontinuing or modifying intervention:

             -  Difficulty with the use of cutting guides and customized titanium plates.

             -  Inaccurate translation of the surgical plan.

        6. Strategies to improve adherence to intervention:

           Postoperative orthodontic treatment is necessary after the operation to obtain the final
           stable occlusion.

        7. Concomitant care:

           Not needed.

        8. Follow up & Evaluation:

      Post-operative treatment will start immediately postoperative (4 hours). The patients will be
      scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.

      Within the first week postoperatively CBCT using same parameters will be ordered to calculate
      the difference between surgical plan and actual outcome will be evaluated.

      Patient will be referred back to the orthodontist to receive his postsurgical orthodontics
      4-6 weeks postoperatively.

      The technique will be evaluated by applying hard tissue parameters to compare the virtual
      orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image
      fusion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: case series
primary purpose: Treatment
masking: None (Open Label)
measure: Accuracy of the surgical transfer
time frame: within first week postoperatively
description: Computer software on pre/postoperative CBCT
measure: Patient satisfaction: Visual analog scale (questionnaire)
time frame: one week postoperative
description: Visual analog scale (questionnaire)
arm group label: study group
arm group type: Experimental
description: using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.
intervention type: Procedure
intervention name: orthognathic surgery
description: patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.
arm group label: study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohammed Zain
investigator title: assistant lecturer
sharing ipd: Yes
ipd info type: Study Protocol