<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/NCT03279042</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-Ortho-04-2017</org_study_id>
    <nct_id>NCT03279042</nct_id>
  </id_info>
  <brief_title>Effectiveness of Two Corticotomy Techniques in Retracting the Upper Anterior Teeth by Using Miniscrews</brief_title>
  <official_title>An Evaluation of the Efficacy of Conventional Corticotomy Versus Flapless Corticotomy in the En-Masse Retraction of Upper Anterior Teeth : A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus 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>
      This study aims to evaluate and compare the skeletal, dental and soft tissue changes, the&#xD;
      levels of pain and discomfort and the effect on periodontal health and teeth vitality&#xD;
      associated to traditional corticotomy and flapless corticotomy in the retraction of upper&#xD;
      anterior teeth.&#xD;
&#xD;
      40 patients requiring extraction of maxillary first premolars and maximum anchorage to&#xD;
      retract the upper anterior teeth will participate in the study. They will be divided randomly&#xD;
      into two groups : flapless corticotomy (20 patients) and traditional corticotomy (20&#xD;
      patients). Pre-retraction, corticotomy will be performed in the maxillary anterior segment.&#xD;
      The skeletal, dental and soft tissue changes will be performed using lateral cephalometric&#xD;
      radiographs which will be obtained pretreatment, pre and post en-masse retraction of the&#xD;
      anterior teeth and we will also use the dental casts to evaluate the dental changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A corticotomy is cutting of the bone involves cortical bone only, leaving intact the&#xD;
      medullary vessels and periosteum It offers an advantage to adult patients in reduction the&#xD;
      orthodontic treatment time. The definition of traditional corticotomy is: elevating&#xD;
      full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made&#xD;
      between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth&#xD;
      apices and connected by a horizontal corticotomy; this process is done on both the labial and&#xD;
      palatal aspects.&#xD;
&#xD;
      The definition of flapless corticotomy is: a minimally invasive version of corticotomy, using&#xD;
      a piezotome in order to inflict bone injury. This technique entails labial and palatal&#xD;
      interproximal piezoelectric microincisions into the cortical bone, without reflecting&#xD;
      periodontal flaps.&#xD;
&#xD;
      Prior to enrollment of each subject into the study, they will be examined completely to&#xD;
      determine the orthodontic treatment plan. The operator will inform them about the aim of the&#xD;
      study and ask them to provide a written informed consent.&#xD;
&#xD;
      Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will&#xD;
      be inserted between the maxillary second premolar and first molar at approximately 8-10mm&#xD;
      above the archwires at the mucogingival junction and will be checked for primary stability&#xD;
      (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary&#xD;
      arch will be levelled and aligned. The rectangular stainless steel archwires (0.019&quot; ×&#xD;
      0.025&quot;) with anterior 8mm height soldered hooks distal to the lateral incisors will be&#xD;
      inserted.&#xD;
&#xD;
      The surgery will be carried out under local anesthesia. The traditional corticotomy will be&#xD;
      handled by the same maxillofacial surgeon and the flapless corticotomy will be handled by the&#xD;
      same orthodontist.&#xD;
&#xD;
      For traditional corticotomy, sulcular incisions the mesial aspect of one second premolar to&#xD;
      the mesial surface of the contralateral second premolar will be placed, and full thickness&#xD;
      flap will be elevated, 3 mm above the apical region of the tooth. piezoelectric under copious&#xD;
      irrigation will be used for making vertical and horizontal cuts (only cortical surface). The&#xD;
      vertical cuts will be between the dental roots in the interdental cortical surfaces ,stopping&#xD;
      2 mm short of the alveolar crest, occlusally. Horizontal cut will connect the vertical cuts 2&#xD;
      mm beyond root apex. These cuts will be performed from the mesial aspect of one second&#xD;
      premolar to the mesial surface of the contralateral second premolar involving the anteriors.&#xD;
      Similarly, a palatal flap incision will be raised immediately for doing the same vertical and&#xD;
      horizontal cuts in the superficial surface of the palatal bone.&#xD;
&#xD;
      For the flapless corticotomy, The depth of gingival tissue will be determined through bone&#xD;
      sounding using a periodontal probe. A scalpel will be used to make the incisions through the&#xD;
      gingiva, 4mm below the interdental papilla to preserve the coronal attached gingiva. These&#xD;
      vertical incisions will be placed from the mesial aspect of one second premolar to the mesial&#xD;
      surface of the contralateral second premolar on the labial and palatal aspects of the maxilla&#xD;
      through the gingiva and the underlying bone. A piezosurgery knife will be used to create the&#xD;
      cortical alveolar incisions to a depth of 1 mm within the cortical bone.&#xD;
&#xD;
      Postoperatively, all patients will be advised to rinse with chlorhexidine mouthwash twice a&#xD;
      day for one week. All patients will be contacted the day after the procedure to ensure no&#xD;
      complications with surgery and will be followed up one month post-surgery to assess for signs&#xD;
      of infection and ensure normal healing. We will assess patients' acceptance and the levels of&#xD;
      pain and discomfort of traditional corticotomy and flapless corticotomy by asking all&#xD;
      patients to fill out 4 questionnaires during the first month after the surgical procedure&#xD;
      using a VAS.&#xD;
&#xD;
      The surgical procedure will be performed and (250-300) g force will be applied on each side&#xD;
      (3-4 days) after corticotomy using two NiTi springs attached between the mini-implants and&#xD;
      the soldered hooks in a direction approximately parallel to the occlusal plane for conducting&#xD;
      an en-masse retraction. The force level will be measured every 2 weeks after the corticotomy&#xD;
      . Retraction will be stopped when a class I canine relationship will be achieved and a good&#xD;
      incisor relationship will be obtained.&#xD;
&#xD;
      Periodontal health will be assessed at the beginning of orthodontic treatment, before and&#xD;
      after corticotomy by evaluating the following parameters: plaque index, gingival index,&#xD;
      bleeding index, and gingival recession.&#xD;
&#xD;
      Dental casts will be used for the quantification of the anteroposterior movement of the&#xD;
      anterior teeth and the first molars every 30 days until class I canine relationship will be&#xD;
      achieved and a good incisor relationship will be obtained.&#xD;
&#xD;
      To evaluate the movement of the anterior teeth: we will project the canine cusp on the median&#xD;
      line and measure the distance from this point to the projected position of a distinct medial&#xD;
      ruga point.&#xD;
&#xD;
      To evaluate the movement of the first molars: we will project the mesial contact point of the&#xD;
      first molar on the median line and measure the distance from this point to the projected&#xD;
      position of a distinct medial ruga point. These measurements will be made with sliding&#xD;
      calipers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2016</start_date>
  <completion_date type="Actual">May 15, 2018</completion_date>
  <primary_completion_date type="Actual">August 12, 2017</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>Duration of en-masse retraction of anterior teeth</measure>
    <time_frame>The months required to compete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.</time_frame>
    <description>Assessment will be performed by calculating the months required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of retraction</measure>
    <time_frame>The calculation of the rate of retraction will be done once the retraction procedures has finished. Completion of this procedure is expected to occur within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Incisors' positions</measure>
    <time_frame>T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)</time_frame>
    <description>Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken at monthly intervals until the end of the retraction phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Molars' positions</measure>
    <time_frame>T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)</time_frame>
    <description>Amount of distance being traveled by the first molars and is going to be measured on study models taken at monthly intervals until the end of the retraction phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the SNA angle</measure>
    <time_frame>The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the SNB angle</measure>
    <time_frame>The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the ANB angle</measure>
    <time_frame>The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the SN.GoMe angle</measure>
    <time_frame>The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the MM angle</measure>
    <time_frame>The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the levels of pain and discomfort</measure>
    <time_frame>Levels of pain will be assessed at : 24 hours following the surgical intervention (T1), one week (T2) , two weeks (T3) and four weeks (T4) following the surgical intervention</time_frame>
    <description>Assessment will be performed using questionnaires via visual analog scales (VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Plaque index</measure>
    <time_frame>This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>The plaque index will be used to assess the status of the oral hygiene in these patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Gingival index</measure>
    <time_frame>This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>The Gingival index will be used to assess the status of the gingival tissues around the teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Bleeding index</measure>
    <time_frame>This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>The plaque index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Recession</measure>
    <time_frame>Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Tooth Vitality</measure>
    <time_frame>This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.</time_frame>
    <description>Tooth vitality will be evaluated for each tooth of the six anterior teeth using Ethyl Chloride applied by a cotton roll.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Class II Div 1 Malocclusion</condition>
  <condition>Protrusion, Incisor</condition>
  <arm_group>
    <arm_group_label>Flapless corticotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flapless corticotomy will be conducted in this group of patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional corticotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional corticotomy will be performed in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flapless corticotomy surgical intervention will be conducted</intervention_name>
    <description>Piezocision will be used to perform the procedure</description>
    <arm_group_label>Flapless corticotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional corticotomy</intervention_name>
    <description>Here the surgery involves elevation of flaps and then conducting the surgical intervention using piezo-surgery cutting saws.</description>
    <arm_group_label>Traditional corticotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with permanent occlusion at age 18-30 years.&#xD;
&#xD;
          -  Comprehensive medical and dental history ruling out any systemic disease&#xD;
&#xD;
          -  Not under any systemic medication.&#xD;
&#xD;
          -  No previous orthodontic treatment&#xD;
&#xD;
          -  Patients with satisfactory periodontal health and Good oral hygiene&#xD;
&#xD;
          -  Need to orthodontic treatment with fixed appliances&#xD;
&#xD;
          -  No congenitally missing teeth except third molars in the maxillary arch&#xD;
&#xD;
          -  Mild or no anterior crowding in maxillary arch.&#xD;
&#xD;
          -  Maximum anchorage, with 75% to 100% of space closure of retraction of anterior segment&#xD;
             in maxillary arch.&#xD;
&#xD;
          -  Therapeutic extraction of maxillary first premolars required.&#xD;
&#xD;
          -  Patients with class Ⅱ division 1 (ANB angle ≤7 degrees) with severe overjet (5-10 mm)&#xD;
&#xD;
          -  Maximum retraction of the anterior teeth was desired.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous orthodontic treatment.&#xD;
&#xD;
          -  Patients with severe skeletal dysplasia in all three dimensions.&#xD;
&#xD;
          -  Patients suffer from systemic diseases or syndromes&#xD;
&#xD;
          -  Patients on medication for systemic disorders, pregnancy or steroid therapy.&#xD;
&#xD;
          -  Patients showing any signs of active periodontal disease&#xD;
&#xD;
          -  Patients with severe crowding (≥ 3.5 mm) in maxillary arch&#xD;
&#xD;
          -  Patients with missing or extracted teeth in maxillary arch except third molar.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanin Nizar Khlef, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>MSc student, Department of Orthodontics, University of Damascus Dental School, Syria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammad Y Hajeer, DDS MSc Phd</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Orthodontics, University of Damascus Dental School, Syria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omar Hashmeh, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Syria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthodontics, University of Damascus Dental School</name>
      <address>
        <city>Damascus</city>
        <zip>DM20AM18</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.</citation>
    <PMID>23787192</PMID>
  </reference>
  <reference>
    <citation>Seo KW, Kwon SY, Kim KA, Park KH, Kim SH, Ahn HW, Nelson G. Displacement pattern of the anterior segment using antero-posterior lingual retractor combined with a palatal plate. Korean J Orthod. 2015 Nov;45(6):289-98. doi: 10.4041/kjod.2015.45.6.289. Epub 2015 Nov 20.</citation>
    <PMID>26629475</PMID>
  </reference>
  <reference>
    <citation>Lee J, Miyazawa K, Tabuchi M, Sato T, Kawaguchi M, Goto S. Effectiveness of en-masse retraction using midpalatal miniscrews and a modified transpalatal arch: Treatment duration and dentoskeletal changes. Korean J Orthod. 2014 Mar;44(2):88-95. doi: 10.4041/kjod.2014.44.2.88. Epub 2014 Mar 19.</citation>
    <PMID>24696825</PMID>
  </reference>
  <reference>
    <citation>Krishnan P, Shetty S, Husain A. An adjunctive minor surgical procedure for increased rate of retraction. J Pharm Bioallied Sci. 2013 Jun;5(Suppl 1):S39-42. doi: 10.4103/0975-7406.113293.</citation>
    <PMID>23946574</PMID>
  </reference>
  <reference>
    <citation>Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25.</citation>
    <PMID>25309863</PMID>
  </reference>
  <reference>
    <citation>Sakthi SV, Vikraman B, Shobana VR, Iyer SK, Krishnaswamy NR. Corticotomy-assisted retraction: an outcome assessment. Indian J Dent Res. 2014 Nov-Dec;25(6):748-54. doi: 10.4103/0970-9290.152191.</citation>
    <PMID>25728107</PMID>
  </reference>
  <reference>
    <citation>Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.</citation>
    <PMID>25478442</PMID>
  </reference>
  <reference>
    <citation>Chung KR, Mitsugi M, Lee BS, Kanno T, Lee W, Kim SH. Speedy surgical orthodontic treatment with skeletal anchorage in adults--sagittal correction and open bite correction. J Oral Maxillofac Surg. 2009 Oct;67(10):2130-48. doi: 10.1016/j.joms.2009.07.002.</citation>
    <PMID>19761907</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>En masse retraction</keyword>
  <keyword>Corticotomy</keyword>
  <keyword>Acceleration of tooth movement</keyword>
  <keyword>Piezocision</keyword>
  <keyword>Flapless corticotomy</keyword>
  <keyword>Class II division 1 malocclusion</keyword>
  <keyword>Protrusion of upper incisors</keyword>
  <keyword>Sliding mechanics</keyword>
  <keyword>mini-implant based anchorage</keyword>
  <keyword>temporary anchorage devices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Overbite</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03279042
org study id: UDDS-Ortho-04-2017
nct id: NCT03279042
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate and compare the skeletal, dental and soft tissue changes, the
      levels of pain and discomfort and the effect on periodontal health and teeth vitality
      associated to traditional corticotomy and flapless corticotomy in the retraction of upper
      anterior teeth.

      40 patients requiring extraction of maxillary first premolars and maximum anchorage to
      retract the upper anterior teeth will participate in the study. They will be divided randomly
      into two groups : flapless corticotomy (20 patients) and traditional corticotomy (20
      patients). Pre-retraction, corticotomy will be performed in the maxillary anterior segment.
      The skeletal, dental and soft tissue changes will be performed using lateral cephalometric
      radiographs which will be obtained pretreatment, pre and post en-masse retraction of the
      anterior teeth and we will also use the dental casts to evaluate the dental changes.
A corticotomy is cutting of the bone involves cortical bone only, leaving intact the
      medullary vessels and periosteum It offers an advantage to adult patients in reduction the
      orthodontic treatment time. The definition of traditional corticotomy is: elevating
      full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made
      between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth
      apices and connected by a horizontal corticotomy; this process is done on both the labial and
      palatal aspects.

      The definition of flapless corticotomy is: a minimally invasive version of corticotomy, using
      a piezotome in order to inflict bone injury. This technique entails labial and palatal
      interproximal piezoelectric microincisions into the cortical bone, without reflecting
      periodontal flaps.

      Prior to enrollment of each subject into the study, they will be examined completely to
      determine the orthodontic treatment plan. The operator will inform them about the aim of the
      study and ask them to provide a written informed consent.

      Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will
      be inserted between the maxillary second premolar and first molar at approximately 8-10mm
      above the archwires at the mucogingival junction and will be checked for primary stability
      (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary
      arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" ×
      0.025") with anterior 8mm height soldered hooks distal to the lateral incisors will be
      inserted.

      The surgery will be carried out under local anesthesia. The traditional corticotomy will be
      handled by the same maxillofacial surgeon and the flapless corticotomy will be handled by the
      same orthodontist.

      For traditional corticotomy, sulcular incisions the mesial aspect of one second premolar to
      the mesial surface of the contralateral second premolar will be placed, and full thickness
      flap will be elevated, 3 mm above the apical region of the tooth. piezoelectric under copious
      irrigation will be used for making vertical and horizontal cuts (only cortical surface). The
      vertical cuts will be between the dental roots in the interdental cortical surfaces ,stopping
      2 mm short of the alveolar crest, occlusally. Horizontal cut will connect the vertical cuts 2
      mm beyond root apex. These cuts will be performed from the mesial aspect of one second
      premolar to the mesial surface of the contralateral second premolar involving the anteriors.
      Similarly, a palatal flap incision will be raised immediately for doing the same vertical and
      horizontal cuts in the superficial surface of the palatal bone.

      For the flapless corticotomy, The depth of gingival tissue will be determined through bone
      sounding using a periodontal probe. A scalpel will be used to make the incisions through the
      gingiva, 4mm below the interdental papilla to preserve the coronal attached gingiva. These
      vertical incisions will be placed from the mesial aspect of one second premolar to the mesial
      surface of the contralateral second premolar on the labial and palatal aspects of the maxilla
      through the gingiva and the underlying bone. A piezosurgery knife will be used to create the
      cortical alveolar incisions to a depth of 1 mm within the cortical bone.

      Postoperatively, all patients will be advised to rinse with chlorhexidine mouthwash twice a
      day for one week. All patients will be contacted the day after the procedure to ensure no
      complications with surgery and will be followed up one month post-surgery to assess for signs
      of infection and ensure normal healing. We will assess patients' acceptance and the levels of
      pain and discomfort of traditional corticotomy and flapless corticotomy by asking all
      patients to fill out 4 questionnaires during the first month after the surgical procedure
      using a VAS.

      The surgical procedure will be performed and (250-300) g force will be applied on each side
      (3-4 days) after corticotomy using two NiTi springs attached between the mini-implants and
      the soldered hooks in a direction approximately parallel to the occlusal plane for conducting
      an en-masse retraction. The force level will be measured every 2 weeks after the corticotomy
      . Retraction will be stopped when a class I canine relationship will be achieved and a good
      incisor relationship will be obtained.

      Periodontal health will be assessed at the beginning of orthodontic treatment, before and
      after corticotomy by evaluating the following parameters: plaque index, gingival index,
      bleeding index, and gingival recession.

      Dental casts will be used for the quantification of the anteroposterior movement of the
      anterior teeth and the first molars every 30 days until class I canine relationship will be
      achieved and a good incisor relationship will be obtained.

      To evaluate the movement of the anterior teeth: we will project the canine cusp on the median
      line and measure the distance from this point to the projected position of a distinct medial
      ruga point.

      To evaluate the movement of the first molars: we will project the mesial contact point of the
      first molar on the median line and measure the distance from this point to the projected
      position of a distinct medial ruga point. These measurements will be made with sliding
      calipers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Duration of en-masse retraction of anterior teeth
time frame: The months required to compete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.
description: Assessment will be performed by calculating the months required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
measure: Rate of retraction
time frame: The calculation of the rate of retraction will be done once the retraction procedures has finished. Completion of this procedure is expected to occur within 6 months in the experimental group and 8 months in the control group.
description: Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.
measure: Change in Incisors' positions
time frame: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
description: Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
measure: Change in Molars' positions
time frame: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
description: Amount of distance being traveled by the first molars and is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
measure: Change in the SNA angle
time frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
description: This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
measure: Change in the SNB angle
time frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
description: This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
measure: Change in the ANB angle
time frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
description: This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
measure: Change in the SN.GoMe angle
time frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
description: This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
measure: Change in the MM angle
time frame: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
description: This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
measure: Change in the levels of pain and discomfort
time frame: Levels of pain will be assessed at : 24 hours following the surgical intervention (T1), one week (T2) , two weeks (T3) and four weeks (T4) following the surgical intervention
description: Assessment will be performed using questionnaires via visual analog scales (VAS)
measure: Change in the Plaque index
time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
description: The plaque index will be used to assess the status of the oral hygiene in these patients.
measure: Change in the Gingival index
time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
description: The Gingival index will be used to assess the status of the gingival tissues around the teeth.
measure: Change in the Bleeding index
time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
description: The plaque index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth.
measure: Gingival Recession
time frame: Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
description: This will be measured in millimeters from the cement-enamel junction to the level of the gingival margin around the six anterior teeth.
measure: Change in Tooth Vitality
time frame: This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.
description: Tooth vitality will be evaluated for each tooth of the six anterior teeth using Ethyl Chloride applied by a cotton roll.
arm group label: Flapless corticotomy
arm group type: Experimental
description: Flapless corticotomy will be conducted in this group of patients.
arm group label: Traditional corticotomy
arm group type: Active Comparator
description: Traditional corticotomy will be performed in this group.
intervention type: Procedure
intervention name: Flapless corticotomy surgical intervention will be conducted
description: Piezocision will be used to perform the procedure
arm group label: Flapless corticotomy
intervention type: Procedure
intervention name: Traditional corticotomy
description: Here the surgery involves elevation of flaps and then conducting the surgical intervention using piezo-surgery cutting saws.
arm group label: Traditional corticotomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: No
last name: Hanin Nizar Khlef, DDS
role: Principal Investigator
affiliation: MSc student, Department of Orthodontics, University of Damascus Dental School, Syria
last name: Mohammad Y Hajeer, DDS MSc Phd
role: Study Director
affiliation: Associate Professor of Orthodontics, University of Damascus Dental School, Syria
last name: Omar Hashmeh, DDS MSc PhD
role: Study Director
affiliation: Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Syria
facility: 
country: Syrian Arab Republic
citation: Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
PMID: 23787192
citation: Seo KW, Kwon SY, Kim KA, Park KH, Kim SH, Ahn HW, Nelson G. Displacement pattern of the anterior segment using antero-posterior lingual retractor combined with a palatal plate. Korean J Orthod. 2015 Nov;45(6):289-98. doi: 10.4041/kjod.2015.45.6.289. Epub 2015 Nov 20.
PMID: 26629475
citation: Lee J, Miyazawa K, Tabuchi M, Sato T, Kawaguchi M, Goto S. Effectiveness of en-masse retraction using midpalatal miniscrews and a modified transpalatal arch: Treatment duration and dentoskeletal changes. Korean J Orthod. 2014 Mar;44(2):88-95. doi: 10.4041/kjod.2014.44.2.88. Epub 2014 Mar 19.
PMID: 24696825
citation: Krishnan P, Shetty S, Husain A. An adjunctive minor surgical procedure for increased rate of retraction. J Pharm Bioallied Sci. 2013 Jun;5(Suppl 1):S39-42. doi: 10.4103/0975-7406.113293.
PMID: 23946574
citation: Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25.
PMID: 25309863
citation: Sakthi SV, Vikraman B, Shobana VR, Iyer SK, Krishnaswamy NR. Corticotomy-assisted retraction: an outcome assessment. Indian J Dent Res. 2014 Nov-Dec;25(6):748-54. doi: 10.4103/0970-9290.152191.
PMID: 25728107
citation: Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.
PMID: 25478442
citation: Chung KR, Mitsugi M, Lee BS, Kanno T, Lee W, Kim SH. Speedy surgical orthodontic treatment with skeletal anchorage in adults--sagittal correction and open bite correction. J Oral Maxillofac Surg. 2009 Oct;67(10):2130-48. doi: 10.1016/j.joms.2009.07.002.
PMID: 19761907
responsible party type: Sponsor
mesh term: Malocclusion
mesh term: Overbite
sharing ipd: No