<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/NCT03764189</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-41</org_study_id>
    <nct_id>NCT03764189</nct_id>
  </id_info>
  <brief_title>Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction</brief_title>
  <official_title>Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      accelerated anterior teeth retraction with the help of microosteoperforation procedure and&#xD;
      miniscrews.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the study contains 2 groups each contains 13 subjects, A control group (anterior segment&#xD;
      retraction with the help of miniscrews) and an intervention group ( anterior segment&#xD;
      retraction with the help of miniscrews and microosteoperforation)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">November 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</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>None (Open Label)</masking>
    <masking_description>not possible as the subject will sign an informed consent and areas of microosteoperforation will be apparent</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of En-masse retraction</measure>
    <time_frame>three to six months</time_frame>
    <description>retracting six anterior teeth</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Root resorption affecting the six anterior teeth.</measure>
    <time_frame>three to six months</time_frame>
    <description>Amount of root volume loss analyzed through CBCT software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tipping affecting the anterior teeth.</measure>
    <time_frame>three to six months</time_frame>
    <description>Changes in angular measurements calculated through CBCT software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extrusion of anterior teeth</measure>
    <time_frame>three to six months</time_frame>
    <description>Linear measurement changes in the clinical height using CBCT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">13</enrollment>
  <condition>Class II Division 1 Malocclusion</condition>
  <arm_group>
    <arm_group_label>en masse retraction only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>anterior segment retraction on miniscrews without microosteoperforation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>en masse retraction with alveocentesis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>anterior segment retraction on miniscrews with microosteoperforation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>microosteoperforation</intervention_name>
    <description>small holes made using large round bur</description>
    <arm_group_label>en masse retraction with alveocentesis</arm_group_label>
    <other_name>accelerated tooth movement</other_name>
    <other_name>alveocentesis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females with an age ranging between 16-30 years.&#xD;
&#xD;
          -  Malocclusion that requires bilateral extraction of the maxillary first premolars and&#xD;
             anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental&#xD;
             protrusions or class II division 1.&#xD;
&#xD;
          -  Healthy dental and periodontal condition with a good oral hygiene&#xD;
&#xD;
          -  Absence of degenerative conditions.&#xD;
&#xD;
          -  Full set of permanent dentition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically compromised patients.&#xD;
&#xD;
          -  Previous orthodontic treatment&#xD;
&#xD;
          -  Patients suffering from any congenital, hereditary or systemic diseases or asymmetries&#xD;
             that might have an influence on tooth movement&#xD;
&#xD;
          -  Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).&#xD;
&#xD;
          -  Active periodontal affection or severe gingival inflammation.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed A Kaddah, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Cairo u</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nashwa abdel m mohamed, master</last_name>
    <phone>01020271313</phone>
    <email>dr.nashwa_87@live.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eman m el sayed, Phd</last_name>
    <phone>01005289453</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>12566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Nashwa abdel m mohamed</last_name>
      <phone>1020271313</phone>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.</citation>
    <PMID>22284287</PMID>
  </reference>
  <reference>
    <citation>Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4</citation>
  </reference>
  <reference>
    <citation>Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.</citation>
    <PMID>3177281</PMID>
  </reference>
  <reference>
    <citation>Blanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21</citation>
  </reference>
  <reference>
    <citation>Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.</citation>
    <PMID>15334614</PMID>
  </reference>
  <reference>
    <citation>Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.</citation>
    <PMID>29454369</PMID>
  </reference>
  <reference>
    <citation>Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier</citation>
  </reference>
  <reference>
    <citation>Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.</citation>
    <PMID>24182579</PMID>
  </reference>
  <reference>
    <citation>Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.</citation>
    <PMID>27275623</PMID>
  </reference>
  <results_reference>
    <citation>Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.</citation>
    <PMID>24326198</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nashwa abdel mohsen mohamed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Accelerated tooth movement AND anterior segment retraction AND miniscrews AND microosteoperforation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All patients' personal data of the patient will be kept safely and no patient data will be used outside the trial unless approved by the patient.</ipd_description>
  </patient_data>
  <!-- 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/NCT03764189
org study id: CEBD-CU-2018-11-41
nct id: NCT03764189
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
accelerated anterior teeth retraction with the help of microosteoperforation procedure and
      miniscrews.
the study contains 2 groups each contains 13 subjects, A control group (anterior segment
      retraction with the help of miniscrews) and an intervention group ( anterior segment
      retraction with the help of miniscrews and microosteoperforation)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: not possible as the subject will sign an informed consent and areas of microosteoperforation will be apparent
measure: Rate of En-masse retraction
time frame: three to six months
description: retracting six anterior teeth
measure: Root resorption affecting the six anterior teeth.
time frame: three to six months
description: Amount of root volume loss analyzed through CBCT software
measure: Tipping affecting the anterior teeth.
time frame: three to six months
description: Changes in angular measurements calculated through CBCT software
measure: Extrusion of anterior teeth
time frame: three to six months
description: Linear measurement changes in the clinical height using CBCT
arm group label: en masse retraction only
arm group type: No Intervention
description: anterior segment retraction on miniscrews without microosteoperforation
arm group label: en masse retraction with alveocentesis
arm group type: Active Comparator
description: anterior segment retraction on miniscrews with microosteoperforation
intervention type: Procedure
intervention name: microosteoperforation
description: small holes made using large round bur
arm group label: en masse retraction with alveocentesis
other name: accelerated tooth movement
other name: alveocentesis
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed A Kaddah, Phd
role: Study Director
affiliation: Cairo u
last name: Nashwa abdel m mohamed, master
phone: 01020271313
email: dr.nashwa_87@live.com
last name: Eman m el sayed, Phd
phone: 01005289453
facility: 
contact: 
country: Egypt
citation: McGorray SP, Dolce C, Kramer S, Stewart D, Wheeler TT. A randomized, placebo-controlled clinical trial on the effects of recombinant human relaxin on tooth movement and short-term stability. Am J Orthod Dentofacial Orthop. 2012 Feb;141(2):196-203. doi: 10.1016/j.ajodo.2011.07.024.
PMID: 22284287
citation: Nicozisis, J., Accelerated Orthodontics With Alveocentesis. Princeton Orthodontics. Clin Orthod, 2012. 19: p. 1-4
citation: Collins MK, Sinclair PM. The local use of vitamin D to increase the rate of orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 1988 Oct;94(4):278-84. doi: 10.1016/0889-5406(88)90052-2.
PMID: 3177281
citation: Blanco, J., et al., Efecto de la administración sistémica del 1, 25 Dihidrxicolecalciferol sobre la velocidad del movimiento ortodóncico en humanos. Estudio Clínico. Revista Odontos, 2001. 8: p. 13-21
citation: Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
PMID: 15334614
citation: Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B. Evaluation of piezocision and laser-assisted flapless corticotomy in the acceleration of canine retraction: a randomized controlled trial. Head Face Med. 2018 Feb 17;14(1):4. doi: 10.1186/s13005-018-0161-9.
PMID: 29454369
citation: Alikhani, M., et al. Micro-osteoperforations: minimally invasive accelerated tooth movement. in Seminars in Orthodontics. 2015. Elsevier
citation: Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.
PMID: 24182579
citation: Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
PMID: 27275623
citation: Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
PMID: 24326198
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Nashwa abdel mohsen mohamed
investigator title: principal investigator
mesh term: Malocclusion
sharing ipd: No
ipd description: All patients' personal data of the patient will be kept safely and no patient data will be used outside the trial unless approved by the patient.