<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/NCT03837652</url>
  </required_header>
  <id_info>
    <org_study_id>SarahSamehMsc</org_study_id>
    <nct_id>NCT03837652</nct_id>
  </id_info>
  <brief_title>Bone-borne Palatal Expander With Corticotomy for Cleft Palate Patients</brief_title>
  <official_title>Evaluation of Bone-borne Palatal Expander in Conjunction With Maxillary Osteotomy in the Treatment of Cleft Palate Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sarah Ahmed Sameh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cairo 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>
      The tooth-borne palatal expander has limitations in the subset of patients with scarred,&#xD;
      constricted cleft palate. At times, although posterior expansion is successful, transverse&#xD;
      expansion of the anterior palate (near the alveolar cleft) is inadequate.&#xD;
&#xD;
      Will the application of bone borne palatal expander combined with a corticotomy be more&#xD;
      effective in the expansion of the constricted maxilla in cleft palate patients?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention:&#xD;
&#xD;
      Application of bone-borne palatal expander in conjunction with maxillary osteotomy for&#xD;
      expansion of constricted maxillae for previously treated cleft palate patients.&#xD;
&#xD;
      o Preoperative Preparations: All data of the patient will be gathered including personal&#xD;
      data, medical history, family history, and classification of palatal cleft will be&#xD;
      registered;&#xD;
&#xD;
        -  Laboratory investigations will be conducted (CBC, coagulation profile, weight). -Models&#xD;
           from dental impressions are made to make standardized measurements which include:-&#xD;
&#xD;
        -  IMD: distance between two lingual grooves of two opposing first molars&#xD;
&#xD;
        -  ICD: distance between cusp tip if two opposing canines&#xD;
&#xD;
        -  Alveolar cleft width&#xD;
&#xD;
        -  Total palatal area&#xD;
&#xD;
        -  The correct distractor module can be measured bone to bone with the fitting models to&#xD;
           choose the distractor length.&#xD;
&#xD;
           o General operative procedures&#xD;
&#xD;
        -  The procedures will be performed under general anesthesia with nasotracheal intubation.&#xD;
&#xD;
        -  Local anaesthesia with vasoconstriction Epinephrine 1:100:000 will be injected in the&#xD;
           palatal mucosa and mucolabial fold.&#xD;
&#xD;
        -  The palatal incision is done between the premolar and molar or between the premolars.&#xD;
&#xD;
        -  Maxillary vestibular incision followed by lateral corticotomy.&#xD;
&#xD;
        -  Placement of distractor plates horizontally and fixing it with self-drilling screws&#xD;
           between two roots on each side.&#xD;
&#xD;
           o Postoperative care:&#xD;
&#xD;
        -  Cephalosporin antibiotic (Ceclor 125mg q12h) for 5 days.&#xD;
&#xD;
        -  Otrivin nasal drops for 5 days.&#xD;
&#xD;
        -  Pyrol drops Analgesic-Antipyretic Paracetamol (Acetaminophen )&#xD;
&#xD;
        -  Patient will be followed up for 10 weeks.&#xD;
&#xD;
        -  Activation of distractor is started after 1 week of surgery using the patient's key&#xD;
           twice daily.&#xD;
&#xD;
        -  Sample size Based on the previous paper by Carpenter et al. 2014, the expected&#xD;
           difference in maximum expansion will be 7.3+/-5.4m. The investigators will need to study&#xD;
           6 patients to be able to reject the null hypothesis that this response difference is&#xD;
           zero with probability (power) o.8. The type I error probability associated with this&#xD;
           test of this null hypothesis is 0.05. This sample size is to be increased to 8 to&#xD;
           compensate for possible losses during follow up. Sample size was calculated using PS:&#xD;
           Power and Sample Size software version 3.1.2 (Vanderbilt University, Nashville,&#xD;
           Tennessee, USA.)&#xD;
&#xD;
        -  Recruitment Strategy&#xD;
&#xD;
        -  Patients will be selected from outpatient clinic of Department of Oral and Maxillofacial&#xD;
           surgery - Cairo University.&#xD;
&#xD;
        -  Screening of patients will continue until the target population is achieved.&#xD;
&#xD;
        -  Identifying and recruiting potential subjects is achieved through patient database.&#xD;
&#xD;
      B) Data collection, management, and analysis&#xD;
&#xD;
        -  Data collection methods&#xD;
&#xD;
             1. Plans for assessment and collection of outcome&#xD;
&#xD;
                  1. Amount of bone expansion will be measured by collecting linear measurements&#xD;
                     from CBCT and dental models.&#xD;
&#xD;
                  2. Patient satisfaction will be measured using patient chart.&#xD;
&#xD;
             2. Plans to promote participant retention and complete follow-up&#xD;
&#xD;
                  1. Telephone numbers of all patients included the study will be recorded as a&#xD;
                     part of the written consent.&#xD;
&#xD;
                  2. All patients will be given a phone call at the time of the predetermined&#xD;
                     follow-up dates.&#xD;
&#xD;
        -  Data management All data will be entered electronically. Patients' files are to be&#xD;
           stored in numerical order and stored in secure and accessible place. All data will be&#xD;
           maintained in storage for 1 year after completion of the study.&#xD;
&#xD;
        -  Statistical methods Data will be analyzed using IBM SPSS advanced statistics&#xD;
           (statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL).&#xD;
           Numerical data will be described as mean and standard deviation or median and range.&#xD;
           Categorical data will be described as numbers and percentages. Data will be explored for&#xD;
           normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. Comparisons between before&#xD;
           and after treatment for normality distributed numeric variables will be done using the&#xD;
           paired t-test while for non- normally distributed numeric variables will be done by&#xD;
           Wilcoxon sign test. A p-value less than or equal to 0.05 will be considered&#xD;
           statistically significant.&#xD;
&#xD;
             1. Outcome:&#xD;
&#xD;
                A suitable statistical test will be used to evaluate palatal expansion.&#xD;
&#xD;
             2. Methods for any additional analysis:&#xD;
&#xD;
      No additional subgroup analysis.&#xD;
&#xD;
      C) Monitoring&#xD;
&#xD;
        -  Data monitoring Data monitoring committee is independent from the supplying company of&#xD;
           the palatal expander.&#xD;
&#xD;
        -  Harms Patient will be closely monitored throughout the post operative period and any&#xD;
           notices adverse effects will be managed as seen appropriate&#xD;
&#xD;
        -  Auditing:&#xD;
&#xD;
      Auditing of the study design will be done by the research committee of the Department of Oral&#xD;
      and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Before and after Study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequate maxillary expansion</measure>
    <time_frame>10-12 weeks post operatively</time_frame>
    <description>Dental casts before treatment &amp; immediately after completion of expansion to determine transverse changes in maxillary arch width measured in millimeter at the following sites:&#xD;
Intermolar width Intercanine width Interarch width 6&#xD;
CBCT before operation &amp; immediately after completion of consolidation period (10 weeks). Distances measured on the coronal images in millimeters before treatment &amp; after the end of the consolidation period:&#xD;
NFW4 &amp; NFW6: Nasal floor width at the area of first premolars &amp; first molars, 5mm above the most inferior part of nasal floor&#xD;
PBW4 &amp; PBW6 : Palatal bone width at the level of a line connecting palatal root apex of first premolars &amp; first molars&#xD;
IRD4: distance between palatal root apex of right &amp; left first premolars&#xD;
IRD6: distance between palatal root apex of right &amp; left first molars</description>
  </primary_outcome>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Cleft Palate</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Use of bone-borne palatal expander &amp; maxillary osteotomy</intervention_name>
    <description>Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with non-syndromic cleft palate.&#xD;
&#xD;
          -  Patients with constricted maxilla after surgical treatment of cleft palate.&#xD;
&#xD;
          -  Patients failed orthodontic expansion.&#xD;
&#xD;
          -  Patients age between 8 and 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic disease or bleeding disorders.&#xD;
&#xD;
          -  Patients with syndromic cleft palate.&#xD;
&#xD;
          -  Patients failed with tooth borne expansion.&#xD;
&#xD;
          -  Patients with fistula in cleft palate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Sameh, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Sameh, BDS</last_name>
    <phone>01001445232</phone>
    <email>sarahahmed35@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Sarah Sameh, BDS</last_name>
      <phone>01001445232</phone>
      <email>sarahahmed35@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Figueiredo DS, Cardinal L, Bartolomeo FU, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders. Dental Press J Orthod. 2016 Nov-Dec;21(6):82-90. doi: 10.1590/2177-6709.2016-001.aop.</citation>
    <PMID>27683832</PMID>
  </reference>
  <reference>
    <citation>Marazita ML, Mooney MP. Current concepts in the embryology and genetics of cleft lip and cleft palate. Clin Plast Surg. 2004 Apr;31(2):125-40. doi: 10.1016/S0094-1298(03)00138-X.</citation>
    <PMID>15145658</PMID>
  </reference>
  <reference>
    <citation>Aziz SR, Tanchyk A. Surgically assisted palatal expansion with a bone-borne self-retaining palatal expander. J Oral Maxillofac Surg. 2008 Sep;66(9):1788-93. doi: 10.1016/j.joms.2008.04.017.</citation>
    <PMID>18718384</PMID>
  </reference>
  <reference>
    <citation>Gunaseelan R, Cheung LK, Krishnaswamy R, Veerabahu M. Anterior maxillary distraction by tooth-borne palatal distractor. J Oral Maxillofac Surg. 2007 May;65(5):1044-9. doi: 10.1016/j.joms.2005.12.049. No abstract available.</citation>
    <PMID>17448861</PMID>
  </reference>
  <reference>
    <citation>Zandi M, Miresmaeili A, Heidari A. Short-term skeletal and dental changes following bone-borne versus tooth-borne surgically assisted rapid maxillary expansion: a randomized clinical trial study. J Craniomaxillofac Surg. 2014 Oct;42(7):1190-5. doi: 10.1016/j.jcms.2014.02.007. Epub 2014 Feb 22.</citation>
    <PMID>24704281</PMID>
  </reference>
  <reference>
    <citation>Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.</citation>
    <PMID>25490552</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sarah Ahmed Sameh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cleft palate</keyword>
  <keyword>transverse discrepancy</keyword>
  <keyword>palatal expansion</keyword>
  <keyword>bone-borne</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Palate</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03837652
org study id: SarahSamehMsc
nct id: NCT03837652
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The tooth-borne palatal expander has limitations in the subset of patients with scarred,
      constricted cleft palate. At times, although posterior expansion is successful, transverse
      expansion of the anterior palate (near the alveolar cleft) is inadequate.

      Will the application of bone borne palatal expander combined with a corticotomy be more
      effective in the expansion of the constricted maxilla in cleft palate patients?
Intervention:

      Application of bone-borne palatal expander in conjunction with maxillary osteotomy for
      expansion of constricted maxillae for previously treated cleft palate patients.

      o Preoperative Preparations: All data of the patient will be gathered including personal
      data, medical history, family history, and classification of palatal cleft will be
      registered;

        -  Laboratory investigations will be conducted (CBC, coagulation profile, weight). -Models
           from dental impressions are made to make standardized measurements which include:-

        -  IMD: distance between two lingual grooves of two opposing first molars

        -  ICD: distance between cusp tip if two opposing canines

        -  Alveolar cleft width

        -  Total palatal area

        -  The correct distractor module can be measured bone to bone with the fitting models to
           choose the distractor length.

           o General operative procedures

        -  The procedures will be performed under general anesthesia with nasotracheal intubation.

        -  Local anaesthesia with vasoconstriction Epinephrine 1:100:000 will be injected in the
           palatal mucosa and mucolabial fold.

        -  The palatal incision is done between the premolar and molar or between the premolars.

        -  Maxillary vestibular incision followed by lateral corticotomy.

        -  Placement of distractor plates horizontally and fixing it with self-drilling screws
           between two roots on each side.

           o Postoperative care:

        -  Cephalosporin antibiotic (Ceclor 125mg q12h) for 5 days.

        -  Otrivin nasal drops for 5 days.

        -  Pyrol drops Analgesic-Antipyretic Paracetamol (Acetaminophen )

        -  Patient will be followed up for 10 weeks.

        -  Activation of distractor is started after 1 week of surgery using the patient's key
           twice daily.

        -  Sample size Based on the previous paper by Carpenter et al. 2014, the expected
           difference in maximum expansion will be 7.3+/-5.4m. The investigators will need to study
           6 patients to be able to reject the null hypothesis that this response difference is
           zero with probability (power) o.8. The type I error probability associated with this
           test of this null hypothesis is 0.05. This sample size is to be increased to 8 to
           compensate for possible losses during follow up. Sample size was calculated using PS:
           Power and Sample Size software version 3.1.2 (Vanderbilt University, Nashville,
           Tennessee, USA.)

        -  Recruitment Strategy

        -  Patients will be selected from outpatient clinic of Department of Oral and Maxillofacial
           surgery - Cairo University.

        -  Screening of patients will continue until the target population is achieved.

        -  Identifying and recruiting potential subjects is achieved through patient database.

      B) Data collection, management, and analysis

        -  Data collection methods

             1. Plans for assessment and collection of outcome

                  1. Amount of bone expansion will be measured by collecting linear measurements
                     from CBCT and dental models.

                  2. Patient satisfaction will be measured using patient chart.

             2. Plans to promote participant retention and complete follow-up

                  1. Telephone numbers of all patients included the study will be recorded as a
                     part of the written consent.

                  2. All patients will be given a phone call at the time of the predetermined
                     follow-up dates.

        -  Data management All data will be entered electronically. Patients' files are to be
           stored in numerical order and stored in secure and accessible place. All data will be
           maintained in storage for 1 year after completion of the study.

        -  Statistical methods Data will be analyzed using IBM SPSS advanced statistics
           (statistical Package for Social Sciences), version 21 (SPSS Inc., Chicago, IL).
           Numerical data will be described as mean and standard deviation or median and range.
           Categorical data will be described as numbers and percentages. Data will be explored for
           normality using Kolmogrov-Smirnov test and Shapiro-Wilk test. Comparisons between before
           and after treatment for normality distributed numeric variables will be done using the
           paired t-test while for non- normally distributed numeric variables will be done by
           Wilcoxon sign test. A p-value less than or equal to 0.05 will be considered
           statistically significant.

             1. Outcome:

                A suitable statistical test will be used to evaluate palatal expansion.

             2. Methods for any additional analysis:

      No additional subgroup analysis.

      C) Monitoring

        -  Data monitoring Data monitoring committee is independent from the supplying company of
           the palatal expander.

        -  Harms Patient will be closely monitored throughout the post operative period and any
           notices adverse effects will be managed as seen appropriate

        -  Auditing:

      Auditing of the study design will be done by the research committee of the Department of Oral
      and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Cairo University.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Before and after Study
primary purpose: Treatment
masking: None (Open Label)
measure: Adequate maxillary expansion
time frame: 10-12 weeks post operatively
description: Dental casts before treatment & immediately after completion of expansion to determine transverse changes in maxillary arch width measured in millimeter at the following sites:
Intermolar width Intercanine width Interarch width 6
CBCT before operation & immediately after completion of consolidation period (10 weeks). Distances measured on the coronal images in millimeters before treatment & after the end of the consolidation period:
NFW4 & NFW6: Nasal floor width at the area of first premolars & first molars, 5mm above the most inferior part of nasal floor
PBW4 & PBW6 : Palatal bone width at the level of a line connecting palatal root apex of first premolars & first molars
IRD4: distance between palatal root apex of right & left first premolars
IRD6: distance between palatal root apex of right & left first molars
intervention type: Other
intervention name: Use of bone-borne palatal expander & maxillary osteotomy
description: Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae
criteria: 
gender: All
minimum age: 6 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Sameh, BDS
role: Principal Investigator
affiliation: Cairo University
last name: Sarah Sameh, BDS
phone: 01001445232
email: sarahahmed35@gmail.com
facility: 
contact: 
country: Egypt
citation: Figueiredo DS, Cardinal L, Bartolomeo FU, Palomo JM, Horta MC, Andrade I Jr, Oliveira DD. Effects of rapid maxillary expansion in cleft patients resulting from the use of two different expanders. Dental Press J Orthod. 2016 Nov-Dec;21(6):82-90. doi: 10.1590/2177-6709.2016-001.aop.
PMID: 27683832
citation: Marazita ML, Mooney MP. Current concepts in the embryology and genetics of cleft lip and cleft palate. Clin Plast Surg. 2004 Apr;31(2):125-40. doi: 10.1016/S0094-1298(03)00138-X.
PMID: 15145658
citation: Aziz SR, Tanchyk A. Surgically assisted palatal expansion with a bone-borne self-retaining palatal expander. J Oral Maxillofac Surg. 2008 Sep;66(9):1788-93. doi: 10.1016/j.joms.2008.04.017.
PMID: 18718384
citation: Gunaseelan R, Cheung LK, Krishnaswamy R, Veerabahu M. Anterior maxillary distraction by tooth-borne palatal distractor. J Oral Maxillofac Surg. 2007 May;65(5):1044-9. doi: 10.1016/j.joms.2005.12.049. No abstract available.
PMID: 17448861
citation: Zandi M, Miresmaeili A, Heidari A. Short-term skeletal and dental changes following bone-borne versus tooth-borne surgically assisted rapid maxillary expansion: a randomized clinical trial study. J Craniomaxillofac Surg. 2014 Oct;42(7):1190-5. doi: 10.1016/j.jcms.2014.02.007. Epub 2014 Feb 22.
PMID: 24704281
citation: Lin L, Ahn HW, Kim SJ, Moon SC, Kim SH, Nelson G. Tooth-borne vs bone-borne rapid maxillary expanders in late adolescence. Angle Orthod. 2015 Mar;85(2):253-62. doi: 10.2319/030514-156.1. Epub 2014 Dec 9.
PMID: 25490552
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Sarah Ahmed Sameh
investigator title: Principal Investigator
mesh term: Cleft Palate
sharing ipd: Undecided