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/NCT05990088</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-ReclR012317</org_study_id>
      <nct_id>NCT05990088</nct_id>
    </id_info>
    <brief_title>Comparison Between Conventional and Neutral Zone CAD/CAM Complete Dentures in Muscle Activity and Occlusal Accuracy</brief_title>
    <official_title>Comparison of Electromyographic Muscle Activity and Occlusal Accuracy Between Conventional and Neutral Zone CAD/CAM Complete Dentures (Randomized Controlled Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A within-subject cross-over study is done on eight completely edentulous patients to compare&#xD;
        two different complete removable dentures. Group I: CAD-CAM ( computer-aided&#xD;
        design/computer-aided manufacturing) conventional complete dentures designed based on the&#xD;
        software algorithms; Group II: CAD-CAM neutral zone complete dentures designed based on the&#xD;
        neutral zone concept. Occlusal analysis is done by the T-Scan device, and evaluation of&#xD;
        muscle activity is conducted by electromyography at insertion time, two weeks after insertion&#xD;
        time, and one month after insertion time.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is designed as a randomized clinical trial applying a within-subject comparison of&#xD;
        two different complete denture types as follows; group I: CAD-CAM conventional complete&#xD;
        dentures designed based on the software algorithms, group II: CAD-CAM neutral zone complete&#xD;
        dentures designed based on the neutral zone concept. The study will be carried out on eight&#xD;
        completely edentulous patients, each patient will receive two sets of complete dentures in a&#xD;
        random sequence. For each denture set, at the denture insertion visit occlusal analysis and&#xD;
        equilibration will be performed with the aid of the T-Scan device, also EMG evaluation of&#xD;
        muscle activity will be conducted. Two weeks after, the patients will be recalled to&#xD;
        reanalyze the occlusion after the denture settles using the T-scan computerized system. One&#xD;
        month after the last recall visit, the EMG evaluation of muscle activity will be conducted&#xD;
        again. The EMG and T-scan recording data will be collected and analyzed to compare the two&#xD;
        denture types&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.</measure>
      <time_frame>one month</time_frame>
      <description>The electromyography activity of the Masseter and Temporalis muscles will be evaluated during clenching, chewing of soft food, and chewing of hard food, at the time of denture insertion (baseline) and one month after baseline.The measuring unit is mv.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of occlusal force equilibration using t-scan device</measure>
      <time_frame>two weeks</time_frame>
      <description>The percentage of occlusal force distribution will be evaluated for both dentures using the T-Scan computerized occlusal analysis system, at the time of denture insertion (baseline) and following baseline by two weeks after.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">8</enrollment>
    <condition>Missing Teeth</condition>
    <condition>Dentures</condition>
    <arm_group>
      <arm_group_label>CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient will be provided by a complete removable denture designed based on the software algorithms to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms</intervention_name>
      <description>The patients will receive complete removable dentures designed based on the software algorithms and digitally manufactured using a milling machine.</description>
      <arm_group_label>CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.</intervention_name>
      <description>The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز</description>
      <arm_group_label>CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a&#xD;
               long period.&#xD;
  &#xD;
            2. Patients with a resorbed mandibular ridge.&#xD;
  &#xD;
            3. Patients with a Class I maxillo-mandibular relationship&#xD;
  &#xD;
            4. Patients with adequate inter-arch space.&#xD;
  &#xD;
            5. Patients with good neuromuscular control.&#xD;
  &#xD;
            6. Patients without any tempo-mandibular disorder.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with any oral diseases that may affect complete denture construction&#xD;
  &#xD;
            2. Patients with bad oral hygiene.&#xD;
  &#xD;
            3. Patients with neuromuscular disorders.&#xD;
  &#xD;
            4. Patients with a history of parafunctional habits.&#xD;
  &#xD;
            5. Hysterical patients.&#xD;
  &#xD;
            6. Patients will undergo or have previously received chemotherapy or radiotherapy.&#xD;
  &#xD;
            7. Drug-addicted patients.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Omnia MS Refai, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Dentistry Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Omar A El-Sadat, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Dentistry Ain Shams University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sara IS Mohamed, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Dentistry , Ain Shams Univeristy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Omnia MS Refai, PHD</last_name>
      <phone>+201202420046</phone>
      <phone_ext>+02</phone_ext>
      <email>omnia_refaie@dent.asu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara IS Mohamed, PHD</last_name>
      <phone>01285446141</phone>
      <phone_ext>+02</phone_ext>
      <email>Saraibrahim@dent.asu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Dentistry, Ain shams University</name>
        <address>
          <city>Cairo</city>
          <zip>11566</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Omnia MS Refai, PHD</last_name>
        <phone>01202420046</phone>
        <phone_ext>+02</phone_ext>
        <email>omnia_refaie@dent.asu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Sara IS Mohamed, PHD</last_name>
        <phone>01285446141</phone>
        <phone_ext>+02</phone_ext>
        <email>Saraibrahim@dent.asu.edu.eg</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Ohkubo C, Shimpo H, Tokue A, Park EJ, Kim TH. Complete denture fabrication using piezography and CAD-CAM: A clinical report. J Prosthet Dent. 2018 Mar;119(3):334-338. doi: 10.1016/j.prosdent.2017.04.013. Epub 2017 Jul 15.</citation>
      <PMID>28720338</PMID>
    </reference>
    <results_reference>
      <citation>Cagna DR, Massad JJ, Schiesser FJ. The neutral zone revisited: from historical concepts to modern application. J Prosthet Dent. 2009 Jun;101(6):405-12. doi: 10.1016/S0022-3913(09)60087-1.</citation>
      <PMID>19463668</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 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>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Omnia M Refai</investigator_full_name>
      <investigator_title>Lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, Ain Shams Univeristy</investigator_title>
    </responsible_party>
    <keyword>CAD-CAM</keyword>
    <keyword>Denture, Complete</keyword>
    <keyword>Electromyography</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tooth Loss</mesh_term>
      <mesh_term>Anodontia</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/NCT05990088
  org study id: FDASU-ReclR012317
  nct id: NCT05990088
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  A within-subject cross-over study is done on eight completely edentulous patients to compare
        two different complete removable dentures. Group I: CAD-CAM ( computer-aided
        design/computer-aided manufacturing) conventional complete dentures designed based on the
        software algorithms; Group II: CAD-CAM neutral zone complete dentures designed based on the
        neutral zone concept. Occlusal analysis is done by the T-Scan device, and evaluation of
        muscle activity is conducted by electromyography at insertion time, two weeks after insertion
        time, and one month after insertion time.
  This study is designed as a randomized clinical trial applying a within-subject comparison of
        two different complete denture types as follows; group I: CAD-CAM conventional complete
        dentures designed based on the software algorithms, group II: CAD-CAM neutral zone complete
        dentures designed based on the neutral zone concept. The study will be carried out on eight
        completely edentulous patients, each patient will receive two sets of complete dentures in a
        random sequence. For each denture set, at the denture insertion visit occlusal analysis and
        equilibration will be performed with the aid of the T-Scan device, also EMG evaluation of
        muscle activity will be conducted. Two weeks after, the patients will be recalled to
        reanalyze the occlusion after the denture settles using the T-scan computerized system. One
        month after the last recall visit, the EMG evaluation of muscle activity will be conducted
        again. The EMG and T-scan recording data will be collected and analyzed to compare the two
        denture types
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Evaluation of the electromyography muscle activity (EMG) of the masseter and temporalis muscles.
  time frame: one month
  description: The electromyography activity of the Masseter and Temporalis muscles will be evaluated during clenching, chewing of soft food, and chewing of hard food, at the time of denture insertion (baseline) and one month after baseline.The measuring unit is mv.
  measure: Evaluation of occlusal force equilibration using t-scan device
  time frame: two weeks
  description: The percentage of occlusal force distribution will be evaluated for both dentures using the T-Scan computerized occlusal analysis system, at the time of denture insertion (baseline) and following baseline by two weeks after.
  arm group label: CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
  arm group type: Experimental
  description: The patient will be provided by a complete removable denture designed based on the software algorithms to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
  arm group label: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
  arm group type: Active Comparator
  description: The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
  intervention type: Device
  intervention name: CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
  description: The patients will receive complete removable dentures designed based on the software algorithms and digitally manufactured using a milling machine.
  arm group label: CAD/CAM Milled Methacrylate Complete Removable Dentures based on the software algorithms
  intervention type: Device
  intervention name: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
  description: The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machineز
  arm group label: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Omnia MS Refai, PHD
  role: Principal Investigator
  affiliation: Faculty of Dentistry Ain Shams University
  last name: Omar A El-Sadat, PHD
  role: Principal Investigator
  affiliation: Faculty of Dentistry Ain Shams University
  last name: Sara IS Mohamed, PHD
  role: Principal Investigator
  affiliation: Faculty of Dentistry , Ain Shams Univeristy
  last name: Omnia MS Refai, PHD
  phone: +201202420046
  phone ext: +02
  email: omnia_refaie@dent.asu.edu.eg
  last name: Sara IS Mohamed, PHD
  phone: 01285446141
  phone ext: +02
  email: Saraibrahim@dent.asu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  citation: Ohkubo C, Shimpo H, Tokue A, Park EJ, Kim TH. Complete denture fabrication using piezography and CAD-CAM: A clinical report. J Prosthet Dent. 2018 Mar;119(3):334-338. doi: 10.1016/j.prosdent.2017.04.013. Epub 2017 Jul 15.
  PMID: 28720338
  citation: Cagna DR, Massad JJ, Schiesser FJ. The neutral zone revisited: from historical concepts to modern application. J Prosthet Dent. 2009 Jun;101(6):405-12. doi: 10.1016/S0022-3913(09)60087-1.
  PMID: 19463668
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Omnia M Refai
  investigator title: Lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry, Ain Shams Univeristy
  mesh term: Tooth Loss
  mesh term: Anodontia