<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/NCT02977221</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-OMFS-01-2016</org_study_id>
    <nct_id>NCT02977221</nct_id>
  </id_info>
  <brief_title>Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment</brief_title>
  <official_title>Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: 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 efficacy of this procedure on 18&#xD;
      patients (experimental group) will be evaluated,whereas the second group (control group) will&#xD;
      receive a traditional orthodontic therapy. The time required to achieve complete alignment of&#xD;
      crowded mandibular anterior teeth (from canine to canine) will be compared between the two&#xD;
      groups.&#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;
      for their effectiveness so far has been limited to case series and a few clinical trials,&#xD;
      generally with small groups. This study aims to provide some evidence about the efficacy of&#xD;
      piezosurgery in a flapless technique to align crowded lower anterior teeth using a&#xD;
      parallel-group randomized controlled trial study design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Duration of tooth alignment</measure>
    <time_frame>This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation</time_frame>
    <description>This outcome will be measured in 'days'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Tooth Alignment at one month</measure>
    <time_frame>Little Index of Irregularity will be measured at 30 days after the onset of treatment.</time_frame>
    <description>This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Tooth Alignment at two months</measure>
    <time_frame>Little Index of Irregularity will be measured at 60 days after the onset of treatment.</time_frame>
    <description>This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Tooth Alignment at last assessment time</measure>
    <time_frame>Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.</time_frame>
    <description>This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Surgical Incision</condition>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>Piezosurgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ordinary Alignment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment will be provided to the patients without any surgical interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Piezosurgery</intervention_name>
    <description>The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior 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: 15-27 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>15 Years</minimum_age>
    <maximum_age>27 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 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 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>piezocision</keyword>
  <keyword>piezosurgery</keyword>
  <keyword>acceleration of tooth movement</keyword>
  <keyword>crowded anterior teeth</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/NCT02977221
org study id: UDDS-OMFS-01-2016
nct id: NCT02977221
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 efficacy of this procedure on 18
      patients (experimental group) will be evaluated,whereas the second group (control group) will
      receive a traditional orthodontic therapy. The time required to achieve complete alignment of
      crowded mandibular anterior teeth (from canine to canine) will be compared between the two
      groups.
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
      for their effectiveness so far has been limited to case series and a few clinical trials,
      generally with small groups. This study aims to provide some evidence about the efficacy of
      piezosurgery in a flapless technique to align crowded lower anterior teeth using a
      parallel-group randomized controlled trial study design.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Duration of tooth alignment
time frame: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
description: This outcome will be measured in 'days'.
measure: Change in Tooth Alignment at one month
time frame: Little Index of Irregularity will be measured at 30 days after the onset of treatment.
description: This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
measure: Change in Tooth Alignment at two months
time frame: Little Index of Irregularity will be measured at 60 days after the onset of treatment.
description: This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
measure: Change in Tooth Alignment at last assessment time
time frame: Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
description: This index is measured on plaster study casts of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment.
arm group label: Piezosurgery
arm group type: Experimental
description: Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding.
arm group label: Ordinary Alignment
arm group type: No Intervention
description: Treatment will be provided to the patients without any surgical interventions.
intervention type: Procedure
intervention name: Piezosurgery
description: The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth.
arm group label: Piezosurgery
other name: Piezocision
criteria: 
gender: All
minimum age: 15 Years
maximum age: 27 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