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/NCT06032702</url>
    </required_header>
    <id_info>
      <org_study_id>BAMDC 0001</org_study_id>
      <nct_id>NCT06032702</nct_id>
    </id_info>
    <brief_title>Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment</brief_title>
    <official_title>Effect of 3 Week vs 6 Week Orthodontic Appointment Intervals on Teeth Alignment in Patients With Moderate to Severe Dental Crowding: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bkahtawar Amin Medical and Dental College Multan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bkahtawar Amin Medical and Dental College Multan</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>
        Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients&#xD;
        with moderate to severe dental crowding: a randomized clinical trial.&#xD;
  &#xD;
        There is still inconclusive evidence about the orthodontics treatment duration and&#xD;
        interappointment interval.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with moderate to severe crowding will be divided randomly into two groups (Group A&#xD;
        and Group B). Group A includes patients with an interval of 3 weeks between their&#xD;
        appointments while Group B includes the patients with an interval of 6 weeks between their&#xD;
        appointments.&#xD;
  &#xD;
          1. To determine the mean changes in the tooth irregularity index of a patient with mild to&#xD;
             moderate crowding activated every 3rd week&#xD;
  &#xD;
          2. To determine the mean changes in the tooth irregularity index of a patient with mild to&#xD;
             moderate crowding activated every 6th week&#xD;
  &#xD;
          3. To compare the difference between the two modalities in percentage&#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">November 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>alignment efficiency and interappointment interval</measure>
      <time_frame>Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements</time_frame>
      <description>Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">72</enrollment>
    <condition>Orthodontic Tooth Movement</condition>
    <condition>Tooth Alignment</condition>
    <arm_group>
      <arm_group_label>3 week interval</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3 week orthodontic interappointment interval</description>
    </arm_group>
    <arm_group>
      <arm_group_label>6 week interval</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 week orthodontic interappointment interval</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>tooth alignment</intervention_name>
      <description>Alignment will be assessed by Little's Irregularity Index</description>
      <arm_group_label>3 week interval</arm_group_label>
      <arm_group_label>6 week interval</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 16-30&#xD;
  &#xD;
            -  Little's irregularity index from 5mm to 12mm&#xD;
  &#xD;
            -  Healthy periodontium&#xD;
  &#xD;
            -  No systemic disease&#xD;
  &#xD;
            -  Patients giving consent for inclusion&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Little's irregularity index less than 5mm and more than 12mm&#xD;
  &#xD;
            -  Blocked out incisors needing push coil&#xD;
  &#xD;
            -  Ankylosed teeth&#xD;
  &#xD;
            -  Active periodontal disease&#xD;
  &#xD;
            -  Systemic bone disease&#xD;
  &#xD;
            -  Non-compliant patients&#xD;
  &#xD;
            -  Patients with frequent breakages&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bakhtawar Amin Medical And Dental College</name>
        <address>
          <city>Multan</city>
          <state>Punjab</state>
          <zip>66000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Waqar Jeelani, BDS,FCPS, MOrth-Edin UK</last_name>
        <phone>00923457936578</phone>
        <email>wjeelani@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Maheen Ahmed, BDS,FCPS, MOrth-Edin UK</last_name>
        <phone>00923002799443</phone>
        <email>a_maheen01@hotmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Undecided</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/NCT06032702
  org study id: BAMDC 0001
  nct id: NCT06032702
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Effect of 3 week vs 6 week orthodontic appointment intervals on teeth alignment in patients
        with moderate to severe dental crowding: a randomized clinical trial.
  
        There is still inconclusive evidence about the orthodontics treatment duration and
        interappointment interval.
  Patients with moderate to severe crowding will be divided randomly into two groups (Group A
        and Group B). Group A includes patients with an interval of 3 weeks between their
        appointments while Group B includes the patients with an interval of 6 weeks between their
        appointments.
  
          1. To determine the mean changes in the tooth irregularity index of a patient with mild to
             moderate crowding activated every 3rd week
  
          2. To determine the mean changes in the tooth irregularity index of a patient with mild to
             moderate crowding activated every 6th week
  
          3. To compare the difference between the two modalities in percentage
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: alignment efficiency and interappointment interval
  time frame: Time frame for measurement of (Little's Irregularity Index) was every 6th week over a period of 6 months, giving a total of 5 measurements
  description: Changes in Little's Irregularity Index between arm 1 and arm 2 and comparison of both interventions.
  arm group label: 3 week interval
  arm group type: Experimental
  description: 3 week orthodontic interappointment interval
  arm group label: 6 week interval
  arm group type: Experimental
  description: 6 week orthodontic interappointment interval
  intervention type: Procedure
  intervention name: tooth alignment
  description: Alignment will be assessed by Little's Irregularity Index
  arm group label: 3 week interval
  arm group label: 6 week interval
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: Undecided
  ipd description: Undecided