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/NCT05978817</url>
    </required_header>
    <id_info>
      <org_study_id>Damon Ultima brack treatment</org_study_id>
      <nct_id>NCT05978817</nct_id>
    </id_info>
    <brief_title>Clinical Effectiveness of Damon Ultima Vs Conventional Brackets Trial)</brief_title>
    <official_title>Clinical Effectiveness of Damon Ultima Vs Conventional Brackets (A Randomized Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Baghdad</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Baghdad</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>
        Compare the clinical performance, root resorption and pain perception between passive&#xD;
        self-ligating Damon Ultema vs conventional brackets.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Damon Ultima System was introduced and claimed to be the first true full expression&#xD;
        orthodontic system designed for faster and more precise finishing. The brackets were&#xD;
        completely reengineered to virtually eliminate play for precise control of rotation,&#xD;
        angulation and torque. Moreover, the system used specially designed archwires regarding wire&#xD;
        dimensions and shape to fulfill the manufacturers claim.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</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>Parallel Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Double (Participant, Outcomes Assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Occlusal outcomes assessment</measure>
      <time_frame>1 year</time_frame>
      <description>1. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores &lt; 0.5 = 0. 0.5 to 1 mm =1. &gt; 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete.&#xD;
  SO:&#xD;
  the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Little Irregularity index:</measure>
      <time_frame>6 months</time_frame>
      <description>This technique involves measuring the linear distance from anatomic contact point to the adjacent anatomic contact point of the mandibular anterior teeth , used to assess the changes in dental alignment throughout the study.&#xD;
  initial irregularity index is (3 mm to 7mm) = worse out come and the final irregularity index is zero mm= best out come</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arch parameter measurement:</measure>
      <time_frame>1 year</time_frame>
      <description>Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Root alingment</measure>
      <time_frame>1 year</time_frame>
      <description>Root movement in 3 plane of space will be evaluated at the end of the alignment phase after insertion of stainless steel wire which may will Tacke about 6 months and at the end of the treatment after about 6 months using CBCT. The inclination of upper and lower teeth will be assessed</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Root resorption</measure>
      <time_frame>1 year</time_frame>
      <description>Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient experience and satisfaction</measure>
      <time_frame>1 year</time_frame>
      <description>The pain perception will be assessed using visual analog scale (VAS) immediately after wire insertion, at 4, 24 hours, 3 days, 7 days, and immediately after each monthly visit (0 no pain, 3 simple pain, 100 very sever pain).&#xD;
  Pain sensitivity questionnaire (PSQ) will be used to assess the patient reliability to pain. This will be done using the Arabic version of PSQ (The patient answer no or yes)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Skeletal and Dental CL I Malocclusion Moderate Crowding</condition>
    <arm_group>
      <arm_group_label>Damon Ultima brackets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Damon Ultima brackets</description>
    </arm_group>
    <arm_group>
      <arm_group_label>conventional Roth appliance</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>conventional Roth appliance</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Damon Ultima bracket</intervention_name>
      <description>It is metal twin bracket with their recommended arch wire</description>
      <arm_group_label>Damon Ultima brackets</arm_group_label>
      <arm_group_label>conventional Roth appliance</arm_group_label>
      <other_name>conventional Roth appliance</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  15-35 years of age patients who are healthy and without medications such as&#xD;
               non-steroidal anti-inflammatory analgesics.&#xD;
  &#xD;
            -  Patients with Class I normal occlusion with moderate dental irregularity (with 4-6&#xD;
               irregularity index) requiring non-extraction treatment.&#xD;
  &#xD;
            -  Presence of all the permanent teeth apart from the third molars.&#xD;
  &#xD;
            -  Patients with good oral hygiene and periodontal health.&#xD;
  &#xD;
            -  Without previous orthodontic treatment/ functional appliances&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients will be excluded from recruitment if he had sever skeletal discrepancy that&#xD;
          requires orthognathic surgery.&#xD;
  &#xD;
          • Patients who have cleft lip or palate, hypodontia, or hyperdontia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dheaa H Al-Groosh, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Baghdad</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nawar A jebory, PHD student</last_name>
      <phone>07809752102</phone>
      <phone_ext>Iraq/ Baghdad</phone_ext>
      <email>nooorznawar@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dheaa H Al-Groosh, PHD</last_name>
      <phone>07737776503</phone>
      <phone_ext>Iraq /Baghdad</phone_ext>
      <email>dheaaha73@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Nawar A jebory</name>
        <address>
          <city>Baghdad</city>
          <country>Iraq</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nawar A jebory</last_name>
        <phone>07809752102</phone>
        <email>nooorznawar@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Dheaa H Al-Groosh</last_name>
        <phone>+9647737776503</phone>
        <email>dheaaha73@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Iraq</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Baghdad</investigator_affiliation>
      <investigator_full_name>Nawar Ahmed Abed</investigator_full_name>
      <investigator_title>Dentist</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malocclusion</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>randomized clinical trial</ipd_description>
    </patient_data>
    <!-- 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/NCT05978817
  org study id: Damon Ultima brack treatment
  nct id: NCT05978817
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Compare the clinical performance, root resorption and pain perception between passive
        self-ligating Damon Ultema vs conventional brackets.
  Damon Ultima System was introduced and claimed to be the first true full expression
        orthodontic system designed for faster and more precise finishing. The brackets were
        completely reengineered to virtually eliminate play for precise control of rotation,
        angulation and torque. Moreover, the system used specially designed archwires regarding wire
        dimensions and shape to fulfill the manufacturers claim.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Double (Participant, Outcomes Assessor)
  measure: Occlusal outcomes assessment
  time frame: 1 year
  description: 1. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores < 0.5 = 0. 0.5 to 1 mm =1. > 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete.
  SO:
  the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome
  measure: Little Irregularity index:
  time frame: 6 months
  description: This technique involves measuring the linear distance from anatomic contact point to the adjacent anatomic contact point of the mandibular anterior teeth , used to assess the changes in dental alignment throughout the study.
  initial irregularity index is (3 mm to 7mm) = worse out come and the final irregularity index is zero mm= best out come
  measure: Arch parameter measurement:
  time frame: 1 year
  description: Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch
  measure: Root alingment
  time frame: 1 year
  description: Root movement in 3 plane of space will be evaluated at the end of the alignment phase after insertion of stainless steel wire which may will Tacke about 6 months and at the end of the treatment after about 6 months using CBCT. The inclination of upper and lower teeth will be assessed
  measure: Root resorption
  time frame: 1 year
  description: Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs.
  measure: Patient experience and satisfaction
  time frame: 1 year
  description: The pain perception will be assessed using visual analog scale (VAS) immediately after wire insertion, at 4, 24 hours, 3 days, 7 days, and immediately after each monthly visit (0 no pain, 3 simple pain, 100 very sever pain).
  Pain sensitivity questionnaire (PSQ) will be used to assess the patient reliability to pain. This will be done using the Arabic version of PSQ (The patient answer no or yes)
  arm group label: Damon Ultima brackets
  arm group type: Experimental
  description: Damon Ultima brackets
  arm group label: conventional Roth appliance
  arm group type: Experimental
  description: conventional Roth appliance
  intervention type: Device
  intervention name: Damon Ultima bracket
  description: It is metal twin bracket with their recommended arch wire
  arm group label: Damon Ultima brackets
  arm group label: conventional Roth appliance
  other name: conventional Roth appliance
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 35 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dheaa H Al-Groosh, PHD
  role: Principal Investigator
  affiliation: University of Baghdad
  last name: Nawar A jebory, PHD student
  phone: 07809752102
  phone ext: Iraq/ Baghdad
  email: nooorznawar@gmail.com
  last name: Dheaa H Al-Groosh, PHD
  phone: 07737776503
  phone ext: Iraq /Baghdad
  email: dheaaha73@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Iraq
  responsible party type: Principal Investigator
  investigator affiliation: University of Baghdad
  investigator full name: Nawar Ahmed Abed
  investigator title: Dentist
  mesh term: Malocclusion
  sharing ipd: Undecided
  ipd description: randomized clinical trial