<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/NCT02975765</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-OMFS-02-2016</org_study_id>
    <nct_id>NCT02975765</nct_id>
  </id_info>
  <brief_title>Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth</brief_title>
  <official_title>Evaluation of the Levels of Pain and Discomfort Between Piezosurgery-assisted Corticotomy Versus Traditional Method of Aligning Crowded Lower 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Applying flapless piezocision corticotomies on the alveolar bone and separating anterior&#xD;
      mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very&#xD;
      accurate incisions without any sutures following this procedure) may improve the speed of&#xD;
      tooth alignment during orthodontic treatment. This study consists of two groups, patients&#xD;
      will be randomly assigned to one of these two groups. The levels of pain and discomfort of&#xD;
      this procedure on 18 patients (experimental group) will be evaluated,whereas the second group&#xD;
      (control group) will receive a traditional orthodontic therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the American Association of Orthodontists (AAO), the length of comprehensive&#xD;
      orthodontic treatment ranges between 18-30 months, depending on treatment options and&#xD;
      individual characteristics. In addition, orthodontic treatment time ranges between 25-35&#xD;
      months for extraction therapies, respectively. Reducing orthodontic treatment time is one of&#xD;
      the main goals for orthodontists, due to problems such as root resorption, periodontal&#xD;
      disease and caries that are associated with prolonged treatment time.&#xD;
&#xD;
      Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and&#xD;
      non-surgical. The surgical approach is the most clinically applied and most tested with known&#xD;
      predictions and stable results. Surgical approaches usually vary from total block osteotomies&#xD;
      to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment&#xD;
      efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps&#xD;
      elevation) might have limited their widespread acceptance among orthodontists and patients.&#xD;
      Therefore, more conservative flapless corticotomy techniques have recently been proposed.&#xD;
      These procedures can be accomplished in a reasonably short periods that might produce less&#xD;
      pain and discomfort, so we will gain better patient acceptance. Although various techniques&#xD;
      of flapless corticotomy have been reported to be successful in practice, scientific evidence&#xD;
      on their acceptance and compatibility is little in the literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">April 23, 2017</completion_date>
  <primary_completion_date type="Actual">December 12, 2016</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>Levels of Pain and Discomfort at one day</measure>
    <time_frame>at 24 hours following the engagement of first initial arch wire in the brackets</time_frame>
    <description>Pain and discomfort will be measured on visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of Pain and Discomfort at seven days</measure>
    <time_frame>at seven days following the onset of orthodontic treatment</time_frame>
    <description>Pain and discomfort will be measured on visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of Pain and Discomfort at 14 days</measure>
    <time_frame>at 14 days following the onset of orthodontic treatment</time_frame>
    <description>Pain and discomfort will be measured on visual analog scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of Pain and Discomfort at 28 days</measure>
    <time_frame>at 28 days following the onset of orthodontic treatment</time_frame>
    <description>Pain and discomfort will be measured on visual analog scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Malocclusion</condition>
  <condition>Crowded Teeth</condition>
  <condition>Surgical Incision</condition>
  <arm_group>
    <arm_group_label>Piezosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional method</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention is going to be applied to the patients in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Piezosurgery</intervention_name>
    <description>The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.</description>
    <arm_group_label>Piezosurgery</arm_group_label>
    <other_name>Piezocision</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult healthy patients , Male and female, Age range: 16-26 years.&#xD;
&#xD;
          2. Severe crowding ≤ 7 (Little's irregularity index)&#xD;
&#xD;
          3. Permanent occlusion.&#xD;
&#xD;
          4. Exist all the Mandibular teeth (except third molars).&#xD;
&#xD;
          5. Good oral and periodontal health:&#xD;
&#xD;
               -  Probing depth&lt;4 mm&#xD;
&#xD;
               -  No radiographic evidence of bone loss .&#xD;
&#xD;
               -  Gingival index≤ 1&#xD;
&#xD;
               -  Plaque index ≤ 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)&#xD;
&#xD;
          2. Patients have anti indication for oral surgery ( medical - social - psycho)&#xD;
&#xD;
          3. Presence of primary teeth in the mandibular arch&#xD;
&#xD;
          4. Missing permanent mandibular teeth (except third molars).&#xD;
&#xD;
          5. Poor oral hygiene or Current periodontal disease:&#xD;
&#xD;
               -  Probing depth ≥ 4 mm&#xD;
&#xD;
               -  radiographic evidence of bone loss&#xD;
&#xD;
               -  Gingival index &gt; 1&#xD;
&#xD;
               -  Plaque index &gt; 1&#xD;
&#xD;
          6. Patient had previous orthodontic treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Omar Gibreal, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bassel Brad, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammad Y Hajeer, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departments of Orthodontics and Oral and Maxillofcial Surgery, 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>Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.</citation>
    <PMID>22105680</PMID>
  </reference>
  <reference>
    <citation>Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.</citation>
    <PMID>17726988</PMID>
  </reference>
  <reference>
    <citation>Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.</citation>
    <PMID>24286911</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 24, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>corticotomy</keyword>
  <keyword>minimally invasive</keyword>
  <keyword>piezosurgery</keyword>
  <keyword>piezocision</keyword>
  <keyword>pain</keyword>
  <keyword>discomfort</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
    <mesh_term>Surgical Wound</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/NCT02975765
org study id: UDDS-OMFS-02-2016
nct id: NCT02975765
lead sponsor: 
has dmc: Yes
Applying flapless piezocision corticotomies on the alveolar bone and separating anterior
      mandibular teeth using a piezosurgery device (i.e. ultrasonic waves that perform very
      accurate incisions without any sutures following this procedure) may improve the speed of
      tooth alignment during orthodontic treatment. This study consists of two groups, patients
      will be randomly assigned to one of these two groups. The levels of pain and discomfort of
      this procedure on 18 patients (experimental group) will be evaluated,whereas the second group
      (control group) will receive a traditional orthodontic therapy.
According to the American Association of Orthodontists (AAO), the length of comprehensive
      orthodontic treatment ranges between 18-30 months, depending on treatment options and
      individual characteristics. In addition, orthodontic treatment time ranges between 25-35
      months for extraction therapies, respectively. Reducing orthodontic treatment time is one of
      the main goals for orthodontists, due to problems such as root resorption, periodontal
      disease and caries that are associated with prolonged treatment time.

      Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and
      non-surgical. The surgical approach is the most clinically applied and most tested with known
      predictions and stable results. Surgical approaches usually vary from total block osteotomies
      to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment
      efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps
      elevation) might have limited their widespread acceptance among orthodontists and patients.
      Therefore, more conservative flapless corticotomy techniques have recently been proposed.
      These procedures can be accomplished in a reasonably short periods that might produce less
      pain and discomfort, so we will gain better patient acceptance. Although various techniques
      of flapless corticotomy have been reported to be successful in practice, scientific evidence
      on their acceptance and compatibility is little in the literature.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Levels of Pain and Discomfort at one day
time frame: at 24 hours following the engagement of first initial arch wire in the brackets
description: Pain and discomfort will be measured on visual analog scale
measure: Levels of Pain and Discomfort at seven days
time frame: at seven days following the onset of orthodontic treatment
description: Pain and discomfort will be measured on visual analog scale
measure: Levels of Pain and Discomfort at 14 days
time frame: at 14 days following the onset of orthodontic treatment
description: Pain and discomfort will be measured on visual analog scale
measure: Levels of Pain and Discomfort at 28 days
time frame: at 28 days following the onset of orthodontic treatment
description: Pain and discomfort will be measured on visual analog scale
arm group label: Piezosurgery
arm group type: Experimental
description: Piezosurgery-assisted corticotomy will be performed to enhance teeth alignment
arm group label: Traditional method
arm group type: No Intervention
description: No intervention is going to be applied to the patients in this group.
intervention type: Procedure
intervention name: Piezosurgery
description: The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.
arm group label: Piezosurgery
other name: Piezocision
criteria: 
gender: All
minimum age: 16 Years
maximum age: 26 Years
healthy volunteers: No
last name: Omar Gibreal, DDS
role: Principal Investigator
affiliation: MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
last name: Bassel Brad, DDS MSc PhD
role: Study Director
affiliation: Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
last name: Mohammad Y Hajeer, DDS MSc PhD
role: Study Director
affiliation: Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
facility: 
country: Syrian Arab Republic
citation: Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
PMID: 22105680
citation: Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
PMID: 17726988
citation: Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
PMID: 24286911
responsible party type: Sponsor
mesh term: Malocclusion
mesh term: Surgical Wound
sharing ipd: No