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/NCT05963438</url>
    </required_header>
    <id_info>
      <org_study_id>2681</org_study_id>
      <nct_id>NCT05963438</nct_id>
    </id_info>
    <brief_title>COMPARISON OF EN-MASSE RETRACTION WITH TWO-STEP RETRACTION USING MINI-IMPLANT AS ANCHORAGE - A RANDOMIZED CONTROL TRIAL</brief_title>
    <official_title>COMPARISON OF EN-MASSE RETRACTION WITH TWO-STEP RETRACTION USING MINI-IMPLANT AS ANCHORAGE - A RANDOMIZED CONTROL TRIAL</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dow University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dow University of Health Sciences</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>
        This Randomized Control Trial will be conducted to compare the effects of en-masse retraction&#xD;
        to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as&#xD;
        anchorage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Extractions of teeth are the commonest approach in treating orthodontic problems. There is&#xD;
        several extraction protocol commonly employed in the orthodontic correction of class II&#xD;
        malocclusion ranging from the extraction of two premolars (20.2%) to four premolars (42.9%).&#xD;
  &#xD;
        Retraction of anterior teeth followed by the extraction of premolars requires anchorage to&#xD;
        restrict the mesial movement of posterior teeth. Anchorage control is a major factor in&#xD;
        achieving successful orthodontic treatment and it can be achieved by variety of appliances,&#xD;
        of which titanium screws have been considered as an absolute source of anchorage in&#xD;
        orthodontics treatment. The anchorage reinforced from mini-implant is helpful in minimizing&#xD;
        anchorage loss and accepted heavy traction forces.&#xD;
  &#xD;
        Retraction of anterior teeth can be achieved either by en-masse retraction, moving all the&#xD;
        six anterior teeth together in a single step or by two-step retraction, separately retract&#xD;
        canines in first step followed by retracting the four anteriors in the second step.&#xD;
  &#xD;
        This Randomized Control Trial will be conducted to compare the effects of en-masse retraction&#xD;
        to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as&#xD;
        anchorage. 80 patients will be included in this study after meeting the eligibility criteria.&#xD;
        Each group will contain 40 patients.&#xD;
  &#xD;
        The patients will be divided in two groups i.e. two-step retraction group (control group) and&#xD;
        en-masse group (experimental group), through software generated randomization table.&#xD;
  &#xD;
        Two-step retraction group (control group) In this group, immediately after placement of&#xD;
        mini-implant and extractions of upper first premolars, heavy ligation will be done from&#xD;
        mini-implant to maxillary second premolar and first molar. Canine will be retracted by&#xD;
        sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will&#xD;
        be activated every three weeks by 1 mm.&#xD;
  &#xD;
        Retraction will be stopped when canines establish class I relationship and a good incisor&#xD;
        relationship will be obtained in both the groups&#xD;
  &#xD;
        En-masse retraction group(experimental group) After placement of mini-implants and extraction&#xD;
        of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height&#xD;
        crimpable hooks distal to the lateral incisors will be inserted and force will be applied&#xD;
        using elastic chains attached between the mini-implant and the hooks for conducting en-masse&#xD;
        retraction. Elastic chains will replace after every three weeks.&#xD;
  &#xD;
        Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment&#xD;
        lateral cephalogram taken after 12 months of orthodontic treatment (T2). All cephalometric&#xD;
        radiograph will be traced on acetate tracing sheets 0.5 μm in thickness using a sharp 4H&#xD;
        pencil on a view box using transilluminated light in a dark room.&#xD;
  &#xD;
        The analysis will be done on pretreatment cephalogram (T1) and post treatment lateral&#xD;
        cephalogram (T2) and then their measurements will be compared to find out changes in the&#xD;
        sagittal, vertical and dental dimensions.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">September 5, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 4, 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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage.</measure>
      <time_frame>Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2).</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Compare the Effects of En-masse Retraction to Two- Steps Retraction</condition>
    <arm_group>
      <arm_group_label>Two-step retraction group (control group)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this group, immediately after placement of mini-implant and extractions of upper first premolars, heavy ligation will be done from mini-implant to maxillary second premolar and first molar. Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will be activated every three weeks by 1 mm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>En-masse retraction group(experimental group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After placement of mini-implants and extraction of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction. Elastic chains will replace after every three weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>anterior retraction</intervention_name>
      <description>After placement of mini-implants and extraction of maxillary first premolar, retraction of anterior either simultaneously or separately depending on the allocated group will be done</description>
      <arm_group_label>En-masse retraction group(experimental group)</arm_group_label>
      <arm_group_label>Two-step retraction group (control group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Both male and female patients with age of 18- 25 years. 2. Cases treated with upper&#xD;
               first premolars extractions. 3. Cases having class II molar relation which is&#xD;
               mesiobuccal cusp of maxillary first permanent molar occludes anterior to the buccal&#xD;
               groove of mandibular first molar on both sides as assessed clinically.&#xD;
  &#xD;
               4. Overjet &gt; 5mm and &lt; 12mm as assessed clinically. 5. Cases with no remaining growth&#xD;
               as assessed by cervical vertebrae maturation stages (cvm) ≥4 on lateral cephalometric&#xD;
               radiograph .&#xD;
  &#xD;
               6. Cases with no congenitally missing teeth (excluding third molars).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Long term use of systemic corticosteroids, calcium channel blockers &amp;&#xD;
               anti-inflammatory drugs.&#xD;
  &#xD;
               2. Cases with syndromes like cleft lip and palate as assessed clinically. 3. Cases in&#xD;
               which active growth is still taking place as assessed by cervical vertebrae maturation&#xD;
               stages (cvm) ≤ 3 on lateral cephalometric radiograph.&#xD;
  &#xD;
               4. Radiographic evidence of bone loss. 5. Periodontal disease as assessed clinically.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anam Sattar, FCPS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dow University of Health Sciences</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Dow University of Health Sciences</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
      <investigator_full_name>Anam Sattar</investigator_full_name>
      <investigator_title>Dr</investigator_title>
    </responsible_party>
    <keyword>En-masse retraction, Two step retraction, mini-implant</keyword>
    <keyword>anchorage</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction will be compared using mini-implants as anchorage</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>at the completion of study</ipd_time_frame>
    </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/NCT05963438
  org study id: 2681
  nct id: NCT05963438
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This Randomized Control Trial will be conducted to compare the effects of en-masse retraction
        to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as
        anchorage.
  Extractions of teeth are the commonest approach in treating orthodontic problems. There is
        several extraction protocol commonly employed in the orthodontic correction of class II
        malocclusion ranging from the extraction of two premolars (20.2%) to four premolars (42.9%).
  
        Retraction of anterior teeth followed by the extraction of premolars requires anchorage to
        restrict the mesial movement of posterior teeth. Anchorage control is a major factor in
        achieving successful orthodontic treatment and it can be achieved by variety of appliances,
        of which titanium screws have been considered as an absolute source of anchorage in
        orthodontics treatment. The anchorage reinforced from mini-implant is helpful in minimizing
        anchorage loss and accepted heavy traction forces.
  
        Retraction of anterior teeth can be achieved either by en-masse retraction, moving all the
        six anterior teeth together in a single step or by two-step retraction, separately retract
        canines in first step followed by retracting the four anteriors in the second step.
  
        This Randomized Control Trial will be conducted to compare the effects of en-masse retraction
        to two- steps retraction on sagittal, vertical and dental dimensions using mini-implant as
        anchorage. 80 patients will be included in this study after meeting the eligibility criteria.
        Each group will contain 40 patients.
  
        The patients will be divided in two groups i.e. two-step retraction group (control group) and
        en-masse group (experimental group), through software generated randomization table.
  
        Two-step retraction group (control group) In this group, immediately after placement of
        mini-implant and extractions of upper first premolars, heavy ligation will be done from
        mini-implant to maxillary second premolar and first molar. Canine will be retracted by
        sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will
        be activated every three weeks by 1 mm.
  
        Retraction will be stopped when canines establish class I relationship and a good incisor
        relationship will be obtained in both the groups
  
        En-masse retraction group(experimental group) After placement of mini-implants and extraction
        of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height
        crimpable hooks distal to the lateral incisors will be inserted and force will be applied
        using elastic chains attached between the mini-implant and the hooks for conducting en-masse
        retraction. Elastic chains will replace after every three weeks.
  
        Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment
        lateral cephalogram taken after 12 months of orthodontic treatment (T2). All cephalometric
        radiograph will be traced on acetate tracing sheets 0.5 μm in thickness using a sharp 4H
        pencil on a view box using transilluminated light in a dark room.
  
        The analysis will be done on pretreatment cephalogram (T1) and post treatment lateral
        cephalogram (T2) and then their measurements will be compared to find out changes in the
        sagittal, vertical and dental dimensions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: To compare sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction using mini-implants as anchorage.
  time frame: Pretreatment lateral cepalogram will be taken at time of enrolment (T1) and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment (T2).
  arm group label: Two-step retraction group (control group)
  arm group type: Other
  description: In this group, immediately after placement of mini-implant and extractions of upper first premolars, heavy ligation will be done from mini-implant to maxillary second premolar and first molar. Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics. Loops will be activated every three weeks by 1 mm.
  arm group label: En-masse retraction group(experimental group)
  arm group type: Experimental
  description: After placement of mini-implants and extraction of maxillary first premolar, rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction. Elastic chains will replace after every three weeks
  intervention type: Procedure
  intervention name: anterior retraction
  description: After placement of mini-implants and extraction of maxillary first premolar, retraction of anterior either simultaneously or separately depending on the allocated group will be done
  arm group label: En-masse retraction group(experimental group)
  arm group label: Two-step retraction group (control group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anam Sattar, FCPS
  role: Principal Investigator
  affiliation: Dow University of Health Sciences
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Dow University of Health Sciences
  investigator full name: Anam Sattar
  investigator title: Dr
  sharing ipd: Yes
  ipd description: sagittal, vertical and dental dimensions following en-masse retraction with two-step retraction will be compared using mini-implants as anchorage
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: at the completion of study