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/NCT05995509</url>
    </required_header>
    <id_info>
      <org_study_id>CPSP/REU/DSG-2017-026-2176</org_study_id>
      <nct_id>NCT05995509</nct_id>
    </id_info>
    <brief_title>The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement.</brief_title>
    <acronym>MOPs</acronym>
    <official_title>The Effect of Number of Micro-osteo-perforations on the Rate of Tooth Movement: A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rehman Medical Institute - RMI</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gandhara University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Rehman Medical Institute - RMI</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>
        The objective of this split mouth trial is to compare mean canine retraction with one&#xD;
        Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic&#xD;
        patients after one month of intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        One of the main concerns for orthodontists and patients who seek orthodontic therapy is the&#xD;
        prolonged treatment time. A commitment of about 18-24 months makes decision making difficult&#xD;
        for many patients. The prolonged treatment time is also a potential factor leading to&#xD;
        complications like white spot lesions, root resorption, gingivitis and periodontitis.&#xD;
        Different techniques to speed up tooth movement have been used in orthodontics.&#xD;
        Micro-osteo-perforations is one of the new ways to expedite tooth movement. Previous trials&#xD;
        of MOP (Micro-osteo-perforations) to expedite tooth movement had certain shortcomings&#xD;
        including the lack of details of randomization. Further studies with variation in the number&#xD;
        and frequency of MOPs over a longer duration were recommended. It also raises a curiosity if&#xD;
        reducing the number of MOPs would be equally effective in accelerating the canine retraction.&#xD;
        Hence, the purpose of this split mouth trial was to investigate the effect of number of MOPs&#xD;
        on the rate of canine retraction.&#xD;
  &#xD;
        The objective of this split mouth trial is to compare mean canine retraction with one MOP&#xD;
        against three MOPs among Class II division I orthodontic patients after one month of&#xD;
        intervention.&#xD;
  &#xD;
        STUDY DESIGN: Split-mouth parallel arm randomized control trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The rate of tooth movement (canine retraction)</measure>
      <time_frame>The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.</time_frame>
      <description>The canine retraction will be measured from a mid-palatine line drawn on the pre treatment and post MOP dental cast. Further perpendicular lines will be drawn towards the distal surface of canine and the mesial surface of the second premolar. The Canine retraction will be measured as the difference between the two lines measured in millimetres. The clinical significance will be set at 50% or more of the rate of canine retraction of the control side.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain associated with MOPs</measure>
      <time_frame>In the surgery after the procedure is completed and just before the patient was sent home.</time_frame>
      <description>The pain or discomfort to the patient will be assessed using a Baker's visual analogue scale on the control and the experimental sides. The scale will be calibrated in millimetres from 0-10 with 0 denoting no pain and 10 denoting worst pain possible.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Orthodontic Tooth Movement</condition>
    <arm_group>
      <arm_group_label>3 MOPs group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>1 MOP group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Micro-osteo-perforations</intervention_name>
      <description>small perforations drilled in Alveolar bone, adjacent to site of tooth movement.</description>
      <arm_group_label>1 MOP group</arm_group_label>
      <arm_group_label>3 MOPs group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: All male and female patients in an age range of 12-25 years requiring&#xD;
          bilateral first premolar extraction in maxillary arch.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with any sort of systemic disease.&#xD;
  &#xD;
            2. Radiographic evidence of bone loss.&#xD;
  &#xD;
            3. History of periodontal therapy&#xD;
  &#xD;
            4. Active periodontal disease.&#xD;
  &#xD;
            5. Patients with a history of smoking of five years or more.&#xD;
  &#xD;
            6. Patients with active gingivitis and Caries.&#xD;
  &#xD;
            7. Attrition of canine cusp.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Imran Tajik, FCPS</last_name>
      <role>Study Chair</role>
      <affiliation>Sardar Begum Dental College</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Javaid</last_name>
      <phone>03349590787</phone>
      <email>asmjavaid@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sohrab Shaheed, FFDRCSI</last_name>
      <phone>03339327608</phone>
      <email>s.shaheed@ymail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>RMI</name>
        <address>
          <city>Peshawar</city>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>RMI</last_name>
        <phone>03349590787</phone>
        <email>asmjavaid@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>RMI</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Micro-osteo-perforations</keyword>
    <keyword>orthodontic tooth movement</keyword>
    <keyword>clinical trial</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05995509
  org study id: CPSP/REU/DSG-2017-026-2176
  nct id: NCT05995509
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this split mouth trial is to compare mean canine retraction with one
        Micro-osteo-perforation (MOP) against three MOPs among Class II division I orthodontic
        patients after one month of intervention.
  One of the main concerns for orthodontists and patients who seek orthodontic therapy is the
        prolonged treatment time. A commitment of about 18-24 months makes decision making difficult
        for many patients. The prolonged treatment time is also a potential factor leading to
        complications like white spot lesions, root resorption, gingivitis and periodontitis.
        Different techniques to speed up tooth movement have been used in orthodontics.
        Micro-osteo-perforations is one of the new ways to expedite tooth movement. Previous trials
        of MOP (Micro-osteo-perforations) to expedite tooth movement had certain shortcomings
        including the lack of details of randomization. Further studies with variation in the number
        and frequency of MOPs over a longer duration were recommended. It also raises a curiosity if
        reducing the number of MOPs would be equally effective in accelerating the canine retraction.
        Hence, the purpose of this split mouth trial was to investigate the effect of number of MOPs
        on the rate of canine retraction.
  
        The objective of this split mouth trial is to compare mean canine retraction with one MOP
        against three MOPs among Class II division I orthodontic patients after one month of
        intervention.
  
        STUDY DESIGN: Split-mouth parallel arm randomized control trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: The rate of tooth movement (canine retraction)
  time frame: The movement of canines on both sides will be measured after 30 days of 150g of force application on the intervention and control side.
  description: The canine retraction will be measured from a mid-palatine line drawn on the pre treatment and post MOP dental cast. Further perpendicular lines will be drawn towards the distal surface of canine and the mesial surface of the second premolar. The Canine retraction will be measured as the difference between the two lines measured in millimetres. The clinical significance will be set at 50% or more of the rate of canine retraction of the control side.
  measure: Pain associated with MOPs
  time frame: In the surgery after the procedure is completed and just before the patient was sent home.
  description: The pain or discomfort to the patient will be assessed using a Baker's visual analogue scale on the control and the experimental sides. The scale will be calibrated in millimetres from 0-10 with 0 denoting no pain and 10 denoting worst pain possible.
  arm group label: 3 MOPs group
  arm group type: Active Comparator
  description: The subjects under a split mouth intervention on the experimental side will undergo 3 micro-osteo-perforations (creating small holes in the buccal cortical bone) to assess the rate of tooth movement.
  arm group label: 1 MOP group
  arm group type: Experimental
  description: the subjects under the split mouth intervention on the control side will undergo 1 micro-osteo-perforation in comparison to the experimental side.
  intervention type: Procedure
  intervention name: Micro-osteo-perforations
  description: small perforations drilled in Alveolar bone, adjacent to site of tooth movement.
  arm group label: 1 MOP group
  arm group label: 3 MOPs group
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Imran Tajik, FCPS
  role: Study Chair
  affiliation: Sardar Begum Dental College
  last name: Javaid
  phone: 03349590787
  email: asmjavaid@gmail.com
  last name: Sohrab Shaheed, FFDRCSI
  phone: 03339327608
  email: s.shaheed@ymail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: No