<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/NCT03260829</url>
  </required_header>
  <id_info>
    <org_study_id>oral and dental medicine</org_study_id>
    <secondary_id>no conflict of interest</secondary_id>
    <nct_id>NCT03260829</nct_id>
  </id_info>
  <brief_title>Efficacy of Injectable Vitamin C on Accelerating Canine Movement: A Clinical Study</brief_title>
  <acronym>mesotherapy</acronym>
  <official_title>Evaluation of the Effect of Local Injected Vitamin C on Accelerating the Orthodontic Movement of Maxillary Canine Impaction: A Clinical 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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      efficacy of the injectable vitamin C to reduce the time of canine traction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective. The purpose of this study is to investigate the role and efficiency of the locally&#xD;
      injected vitamin C in the enhancement of the palatally impacted canine movement.&#xD;
&#xD;
      Design. Twelve adult patients with unilateral palatally impacted canines were included in&#xD;
      this study. The enrolled patients were randomly allocated into the study groups; control&#xD;
      group; orthodontic traction and he test group: orthodontic traction enhanced by&#xD;
      intraepidermic vitamin C injection. The study duration was 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of tooth movement</measure>
    <time_frame>12 months</time_frame>
    <description>the achieved movement in millimeters in one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>level of alveolar bone</measure>
    <time_frame>12 months</time_frame>
    <description>the level of the interproximal and facial alveolar bone after orthodontic treatment with or without injection</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Palatally Impacted Canines</condition>
  <arm_group>
    <arm_group_label>vitamin C injection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>orthodontic traction with vitamin C injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>orthodontic traction</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>orthodontic traction without vitamin C injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>vitamin C</intervention_name>
    <description>25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved</description>
    <arm_group_label>orthodontic traction</arm_group_label>
    <arm_group_label>vitamin C injection</arm_group_label>
    <other_name>ascorbic acid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  medically free&#xD;
&#xD;
          -  patient with good to fair oral hygiene (gingivitis may be included)&#xD;
&#xD;
          -  both sexes were included&#xD;
&#xD;
          -  unilateral palatally positioned permenant canines&#xD;
&#xD;
          -  absence of previous orthodontic treatment&#xD;
&#xD;
          -  absence of supernumerary teeth, odontoms, cysts, traumatic injuries&#xD;
&#xD;
          -  the α angle within grade II to III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases especially diabetes and bone diseases&#xD;
&#xD;
          -  pregnant and lactating mothers&#xD;
&#xD;
          -  Local causes (smoking, mouth breathing, local trauma and periodontitis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine</name>
      <address>
        <city>Gizah</city>
        <state>Giza</state>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.</citation>
    <PMID>1</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>nermin mohammed ahmed yussif</investigator_full_name>
    <investigator_title>assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>vitamin C</keyword>
  <keyword>palatally impacted canines</keyword>
  <keyword>intraepidermal injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03260829
org study id: oral and dental medicine
secondary id: no conflict of interest
nct id: NCT03260829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
efficacy of the injectable vitamin C to reduce the time of canine traction
Objective. The purpose of this study is to investigate the role and efficiency of the locally
      injected vitamin C in the enhancement of the palatally impacted canine movement.

      Design. Twelve adult patients with unilateral palatally impacted canines were included in
      this study. The enrolled patients were randomly allocated into the study groups; control
      group; orthodontic traction and he test group: orthodontic traction enhanced by
      intraepidermic vitamin C injection. The study duration was 12 months.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: rate of tooth movement
time frame: 12 months
description: the achieved movement in millimeters in one year
measure: level of alveolar bone
time frame: 12 months
description: the level of the interproximal and facial alveolar bone after orthodontic treatment with or without injection
arm group label: vitamin C injection
arm group type: Active Comparator
description: orthodontic traction with vitamin C injection
arm group label: orthodontic traction
arm group type: Placebo Comparator
description: orthodontic traction without vitamin C injection
intervention type: Drug
intervention name: vitamin C
description: 25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved
arm group label: orthodontic traction
arm group label: vitamin C injection
other name: ascorbic acid
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Makar AB, McMartin KE, Palese M, Tephly TR. Formate assay in body fluids: application in methanol poisoning. Biochem Med. 1975 Jun;13(2):117-26. doi: 10.1016/0006-2944(75)90147-7. No abstract available.
PMID: 1
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: nermin mohammed ahmed yussif
investigator title: assistant lecturer
mesh term: Tooth, Impacted
mesh term: Ascorbic Acid