<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/NCT03011489</url>
  </required_header>
  <id_info>
    <org_study_id>UCLP_Vacuum</org_study_id>
    <nct_id>NCT03011489</nct_id>
  </id_info>
  <brief_title>Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled Clinical Trial</brief_title>
  <official_title>Parent's Satisfaction and Evaluation of Postsurgical Outcomes in Unilateral Cleft Lip / Palate Newly Born Infants With / Without Vacuum Formed Nasoalveolar Molding Aligners : A Controlled 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed&#xD;
      aligners in order to evaluate its effect on Nasoalveolar complex.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group&#xD;
      will receive Vacuum formed aligners while control group will not receive Vacuum formed&#xD;
      aligners.&#xD;
&#xD;
      the follow-up period will be 3 months till surgical lip closure. the assessment will be&#xD;
      through a questionnaire for the parents' satisfaction outcome, standardized photographs for&#xD;
      measurement of nasal changes and interlabial gap outcome and digital maxillary models for the&#xD;
      maxillary dimension change outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parents' satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>It will be measured by questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Nasal morphology( Height, width, angulation of columella</measure>
    <time_frame>3 months</time_frame>
    <description>It will be measured in mm by Standardized Digital photographs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Interlabial gab</measure>
    <time_frame>3 months</time_frame>
    <description>It will be measured in mm by Standardized Digital photographs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Maxillary arch dimension</measure>
    <time_frame>3 months</time_frame>
    <description>It will be measured in mm by Digital models</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Cleft Lip and Palate</condition>
  <arm_group>
    <arm_group_label>Vacuum formed aligners group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will not receive any treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vacuum formed aligners</intervention_name>
    <description>Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.</description>
    <arm_group_label>Vacuum formed aligners group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-syndromic Infants with complete unilateral cleft lip and palate&#xD;
&#xD;
          -  Infants less than 3 months of age&#xD;
&#xD;
          -  Males and females.&#xD;
&#xD;
          -  Infants with displaced alveolus&#xD;
&#xD;
          -  Patients whose parents provided written consent for the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients above 3 months of age&#xD;
&#xD;
          -  Syndromic, malnourished and systemically ill infants.&#xD;
&#xD;
          -  Patients with bilateral cleft lip and palate.&#xD;
&#xD;
          -  Incomplete Cleft lip.&#xD;
&#xD;
          -  Medically compromised patients&#xD;
&#xD;
          -  Patient's/guardians who will be unwilling to go through the PNAM therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatma Abdu Abdelsayed, professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Khadega Ali Al Khateeb, Master</last_name>
    <phone>00201100739869</phone>
    <email>khadejaalkhateeb@yahoo.com</email>
  </overall_contact>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>April 22, 2017</last_update_submitted>
  <last_update_submitted_qc>April 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Khadega Ali Al Khateeb</investigator_full_name>
    <investigator_title>Master student, faculty of oral and dental medicine, Cairo university</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Lip</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/NCT03011489
org study id: UCLP_Vacuum
nct id: NCT03011489
lead sponsor: 
has dmc: No
Newborns with unilateral cleft lip/ palate will be treated pre-surgically by Vacuum formed
      aligners in order to evaluate its effect on Nasoalveolar complex.
newborns with unilateral cleft lip/ palate will be allocated into two groups: treatment group
      will receive Vacuum formed aligners while control group will not receive Vacuum formed
      aligners.

      the follow-up period will be 3 months till surgical lip closure. the assessment will be
      through a questionnaire for the parents' satisfaction outcome, standardized photographs for
      measurement of nasal changes and interlabial gap outcome and digital maxillary models for the
      maxillary dimension change outcome.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Parents' satisfaction
time frame: 3 months
description: It will be measured by questionnaire
measure: Changes in Nasal morphology( Height, width, angulation of columella
time frame: 3 months
description: It will be measured in mm by Standardized Digital photographs
measure: Changes in Interlabial gab
time frame: 3 months
description: It will be measured in mm by Standardized Digital photographs
measure: Changes in Maxillary arch dimension
time frame: 3 months
description: It will be measured in mm by Digital models
arm group label: Vacuum formed aligners group
arm group type: Experimental
description: This group will receive Vacuum formed aligners in addition to taping for 3 Months with follow-up every 1-2 weeks
arm group label: control group
arm group type: No Intervention
description: This group will not receive any treatment
intervention type: Device
intervention name: Vacuum formed aligners
description: Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
arm group label: Vacuum formed aligners group
criteria: 
gender: All
minimum age: 1 Week
maximum age: 3 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Fatma Abdu Abdelsayed, professor
role: Study Director
affiliation: Cairo University
last name: Khadega Ali Al Khateeb, Master
phone: 00201100739869
email: khadejaalkhateeb@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Khadega Ali Al Khateeb
investigator title: Master student, faculty of oral and dental medicine, Cairo university
mesh term: Cleft Lip
sharing ipd: No