<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/NCT03782766</url>
  </required_header>
  <id_info>
    <org_study_id>416/2016</org_study_id>
    <nct_id>NCT03782766</nct_id>
  </id_info>
  <brief_title>Mandibular Second Molar Protraction Assisted by Piezocision</brief_title>
  <official_title>Mandibular Second Molar Protraction Assisted by and Piezocision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jordan University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jordan University of Science and Technology</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 study was conducted to compare the rate of second molar protraction, level of&#xD;
      Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque&#xD;
      index, and periodontal pocket depth) and perception of pain in patients treated by molar&#xD;
      protraction with piezocision vs control (no piezocision).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first&#xD;
      molar were selected to participate in the study. The subjects were subdivided into one of 3&#xD;
      groups as follows: group 1 consisted of 18 molars (13 molars from patients with bilateral&#xD;
      first molar extraction space and 5 molars from patients with unilateral first molar&#xD;
      extraction space) where piezocision was performed immediately before molar protraction; group&#xD;
      2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8&#xD;
      molars from patients with unilateral first molar extraction space) where molar protraction&#xD;
      was performed with no piezocision; group 3 consisted of 21 molars (group 2 subjects where&#xD;
      piezocision was carried on after 3 months of molar protraction with no piezocision. After&#xD;
      reaching 0.019X0.025&quot; SS arch wire, NiTi coil spring was used for space closure (protraction&#xD;
      force was 150g) attached from the lower second molar hook to the head of the mini-screw.&#xD;
      Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction&#xD;
      space. Piezotome was inserted in the incisions previously made and bone cuts were done with a&#xD;
      length up to mucogingival line and depth of 3 mm.&#xD;
&#xD;
      Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower&#xD;
      second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4&#xD;
      weeks after molar protraction with piezocision or with no piezocision. Pain was assessed&#xD;
      using visual analog scale (VAS). Patients were requested to report the level of pain for 7&#xD;
      consecutive days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2015</start_date>
  <completion_date type="Actual">October 4, 2018</completion_date>
  <primary_completion_date type="Actual">October 4, 2018</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>Three models:-&#xD;
Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects.&#xD;
comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision.&#xD;
third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of second molar protraction</measure>
    <time_frame>up to 3 months</time_frame>
    <description>measured in mm/month from onscreen dental cast</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the level of of Interleukin1-β</measure>
    <time_frame>Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision</time_frame>
    <description>detected in Gingival crevicular fluid (GCF)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anchorage loss</measure>
    <time_frame>Each month up to 3 months</time_frame>
    <description>Distal movement of second premolar in mm per month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Perception: Visual analogue scale (VAS)</measure>
    <time_frame>Every day up to 7 days</time_frame>
    <description>Assessed using visual analog scale (VAS) where 0 = no pain and 10 = worst pain. The participants filled out questionnaire to assess the pain intensity and interference after second molar protraction with or without piezocision on 1, 2, 3, 4, 5, 6 and 7 days of intervention.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Acceleration of Tooth Movement</condition>
  <condition>Piezocision</condition>
  <arm_group>
    <arm_group_label>piezosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocesion was performed immediately before molar protraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No piezocision</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocesion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late piezocision</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Piezocision</intervention_name>
    <description>Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.</description>
    <arm_group_label>Late piezocision</arm_group_label>
    <arm_group_label>piezosurgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age range from 20 to 27 years&#xD;
&#xD;
          -  at least one extracted mandibular first molar (first molar extracted more than one&#xD;
             year ago and residual extraction space more than 5 mm)&#xD;
&#xD;
          -  Class 1 malocclusion where molar protraction is indicated&#xD;
&#xD;
          -  all permanent teeth are present except for the extracted mandibular first&#xD;
             molar/molars.&#xD;
&#xD;
        Exclusion Criteria:-&#xD;
&#xD;
          -  Ggingival index score &gt; 2&#xD;
&#xD;
          -  Plaque index score &gt; 2&#xD;
&#xD;
          -  Probing depth &gt; 4mm&#xD;
&#xD;
          -  Previous orthodontic treatment&#xD;
&#xD;
          -  Systemic disease and&#xD;
&#xD;
          -  Smoker.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>27 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elham S A Alhaija</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof.- Main thesis supervisor</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jordan University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Elham Abu Alhaija</investigator_full_name>
    <investigator_title>Principal Investigator - Main thesis supervisor</investigator_title>
  </responsible_party>
  <keyword>Piezocision</keyword>
  <keyword>Temporary anchorage device</keyword>
  <keyword>molar protraction</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03782766
org study id: 416/2016
nct id: NCT03782766
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study was conducted to compare the rate of second molar protraction, level of
      Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque
      index, and periodontal pocket depth) and perception of pain in patients treated by molar
      protraction with piezocision vs control (no piezocision).
Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first
      molar were selected to participate in the study. The subjects were subdivided into one of 3
      groups as follows: group 1 consisted of 18 molars (13 molars from patients with bilateral
      first molar extraction space and 5 molars from patients with unilateral first molar
      extraction space) where piezocision was performed immediately before molar protraction; group
      2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8
      molars from patients with unilateral first molar extraction space) where molar protraction
      was performed with no piezocision; group 3 consisted of 21 molars (group 2 subjects where
      piezocision was carried on after 3 months of molar protraction with no piezocision. After
      reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction
      force was 150g) attached from the lower second molar hook to the head of the mini-screw.
      Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction
      space. Piezotome was inserted in the incisions previously made and bone cuts were done with a
      length up to mucogingival line and depth of 3 mm.

      Gingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower
      second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4
      weeks after molar protraction with piezocision or with no piezocision. Pain was assessed
      using visual analog scale (VAS). Patients were requested to report the level of pain for 7
      consecutive days.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three models:-
Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects.
comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision.
third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,
primary purpose: Treatment
measure: Rate of second molar protraction
time frame: up to 3 months
description: measured in mm/month from onscreen dental cast
measure: Changes in the level of of Interleukin1-β
time frame: Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision
description: detected in Gingival crevicular fluid (GCF)
measure: Anchorage loss
time frame: Each month up to 3 months
description: Distal movement of second premolar in mm per month
measure: Pain Perception: Visual analogue scale (VAS)
time frame: Every day up to 7 days
description: Assessed using visual analog scale (VAS) where 0 = no pain and 10 = worst pain. The participants filled out questionnaire to assess the pain intensity and interference after second molar protraction with or without piezocision on 1, 2, 3, 4, 5, 6 and 7 days of intervention.
arm group label: piezosurgery
arm group type: Experimental
description: group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocesion was performed immediately before molar protraction
arm group label: No piezocision
arm group type: No Intervention
description: group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocesion
arm group label: Late piezocision
arm group type: Other
description: group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion.
intervention type: Procedure
intervention name: Piezocision
description: Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
arm group label: Late piezocision
arm group label: piezosurgery
criteria: 
gender: All
minimum age: 20 Years
maximum age: 27 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elham S A Alhaija
role: Principal Investigator
affiliation: Prof.- Main thesis supervisor
responsible party type: Principal Investigator
investigator affiliation: Jordan University of Science and Technology
investigator full name: Elham Abu Alhaija
investigator title: Principal Investigator - Main thesis supervisor