<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/NCT03027765</url>
  </required_header>
  <id_info>
    <org_study_id>Space Maintainers</org_study_id>
    <nct_id>NCT03027765</nct_id>
  </id_info>
  <brief_title>Prevalence of Constructed Space Maintainers in a Group of Egyptian Children</brief_title>
  <official_title>Prevalence of Constructed Space Maintainers in a Group of Egyptian Children Attending Pediatric Dentistry Department, Faculty of Oral and Dental Medicine Cairo University. A Cross-Sectional Study</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>
      The purpose of the study is&#xD;
&#xD;
        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and&#xD;
           Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.&#xD;
&#xD;
        -  To assess the knowledge, attitude and awareness of constructed space maintainers for&#xD;
           pediatric patients' guardians at Pediatric Dentistry and Dental Public Health&#xD;
           Department, Faculty of Oral and Dental Medicine, Cairo University.&#xD;
&#xD;
      and&#xD;
&#xD;
      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space&#xD;
      maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty&#xD;
      of Oral and Dental Medicine, Cairo University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is&#xD;
&#xD;
        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and&#xD;
           Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.&#xD;
&#xD;
        -  To assess the knowledge, attitude and awareness of constructed space maintainers for&#xD;
           pediatric patients' guardians at Pediatric Dentistry and Dental Public Health&#xD;
           Department, Faculty of Oral and Dental Medicine, Cairo University.&#xD;
&#xD;
      and&#xD;
&#xD;
      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space&#xD;
      maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty&#xD;
      of Oral and Dental Medicine, Cairo University.&#xD;
&#xD;
      PO1:&#xD;
&#xD;
      Population:&#xD;
&#xD;
      Egyptian children with constructed space maintainers and their guardians attending Pediatric&#xD;
      Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo&#xD;
      University.&#xD;
&#xD;
      Outcome1:&#xD;
&#xD;
      Prevalence of constructed space maintainers Knowledge, attitude and awareness of constructed&#xD;
      space maintainers for pediatric patients' guardians.&#xD;
&#xD;
      PO2&#xD;
&#xD;
      Population2:&#xD;
&#xD;
      Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of&#xD;
      Oral and Dental Medicine, Cairo University.&#xD;
&#xD;
      Outcome2:&#xD;
&#xD;
      knowledge, attitude and practice of pediatric dentists towards the use of the space&#xD;
      maintainers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of constructed space maintainers</measure>
    <time_frame>6 months</time_frame>
    <description>Device for measurement through Visual examination and unit is Binary (Yes, No) and MCQ</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Tooth Loss</condition>
  <arm_group>
    <arm_group_label>Egyptian children</arm_group_label>
    <description>Population1:&#xD;
Egyptian children with constructed space maintainers at Cairo University.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pediatric dentists</arm_group_label>
    <description>Population2:&#xD;
Pediatric dentists at Cairo University.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian children with constructed space maintainers and their guardians attending&#xD;
        Pediatric Dentistry and Dental Public Health Department, Faculty of Oral and Dental&#xD;
        Medicine, Cairo University Both gender are included and Pediatric dentists at Pediatric&#xD;
        Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo&#xD;
        University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        i have two population&#xD;
&#xD;
        1st population is Pediatric patients&#xD;
&#xD;
        Inclusion criteria for pediatric patients:&#xD;
&#xD;
          1. All patients with constructed space maintainers&#xD;
&#xD;
          2. Positive patient's acceptance for participation in the study.&#xD;
&#xD;
          3. Both genders are included.&#xD;
&#xD;
          4. Children Medically free from any systemic disease.&#xD;
&#xD;
        Exclusion criteria for pediatric patients:&#xD;
&#xD;
          1. Patients with orthodontic appliances.&#xD;
&#xD;
          2. Patient having one of the different following habit thumb sucking, lip biting, tongue&#xD;
             thrusting etc.&#xD;
&#xD;
        2nd population is pediatric dentists:&#xD;
&#xD;
        Inclusion criteria for Pediatric dentists:&#xD;
&#xD;
        -All Pediatric dentists having master degree and above.&#xD;
&#xD;
        Exclusion criteria for Pediatric dentists:&#xD;
&#xD;
        -Pediatric dentists refused to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherine Ezz Eldin Taha, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yara AbdulWahab AbdulHameed Moawad, bachelor</last_name>
    <phone>+201116108317</phone>
    <email>yaramoawad@rocketmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fatma Korany, Lecturer</last_name>
    <phone>01006753265</phone>
    <email>fatmadent@hotmail.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Ari T. Follow-up problems with fixed appliances in pediatric dentistry. N Y State Dent J. 2015 Mar;81(2):16-20.</citation>
    <PMID>25928968</PMID>
  </reference>
  <reference>
    <citation>Asiry MA. Occlusal Status among 12-16 Year-Old School Children in Riyadh, Saudi Arabia. J Int Oral Health. 2015 May;7(5):20-3.</citation>
    <PMID>26028897</PMID>
  </reference>
  <reference>
    <citation>Baroni C, Franchini A, Rimondini L. Survival of different types of space maintainers. Pediatr Dent. 1994 Sep-Oct;16(5):360-1. No abstract available.</citation>
    <PMID>7831141</PMID>
  </reference>
  <reference>
    <citation>Brothwell DJ. Guidelines on the use of space maintainers following premature loss of primary teeth. J Can Dent Assoc. 1997 Nov;63(10):753, 757-60, 764-6.</citation>
    <PMID>9401297</PMID>
  </reference>
  <reference>
    <citation>Dhar V, Jain A, Van Dyke TE, Kohli A. Prevalence of gingival diseases, malocclusion and fluorosis in school-going children of rural areas in Udaipur district. J Indian Soc Pedod Prev Dent. 2007 Apr-Jun;25(2):103-5. doi: 10.4103/0970-4388.33458.</citation>
    <PMID>17660647</PMID>
  </reference>
  <reference>
    <citation>Dogan MC, Dogan SK, Kendi E. Complications of pediatric denture misuse: a case report. Oral Health Prev Dent. 2005;3(2):127-30.</citation>
    <PMID>16173390</PMID>
  </reference>
  <reference>
    <citation>Green J. Mind the gap: Overview of space maintaining appliances. Dent Nurs 2015; 11(1):24-7.</citation>
  </reference>
  <reference>
    <citation>Kapala JT. Interceptive orthodontics and management of space problems. In: Braham RL, Morris ME. Textbook of Pediatric Dentistry, Eds. Baltimore, London, William &amp; Wilkins Co. 1980: pp 320-356.</citation>
  </reference>
  <reference>
    <citation>Keski-Nisula K, Hernesniemi R, Heiskanen M, Keski-Nisula L, Varrela J. Orthodontic intervention in the early mixed dentition: a prospective, controlled study on the effects of the eruption guidance appliance. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):254-60; quiz 328.e2. doi: 10.1016/j.ajodo.2006.05.039.</citation>
    <PMID>18249292</PMID>
  </reference>
  <reference>
    <citation>Laing E, Ashley P, Naini FB, Gill DS. Space maintenance. Int J Paediatr Dent. 2009 May;19(3):155-62. doi: 10.1111/j.1365-263X.2008.00951.x.</citation>
    <PMID>19385999</PMID>
  </reference>
  <reference>
    <citation>Leite-Cavalcanti A,de Alencar, Benzerra PK,Garcia A., Prevalence of early loss of primary molars in school children in Brazil. Pak Oral Dent J 2008; 28:113-6.</citation>
  </reference>
  <reference>
    <citation>Petrunov V. Epidemiological research of malocclusions and the need of orthodontic treatment among the Bulgarians in the mixed to permanent dentition period, Disertation, Sofia 2012, p.62</citation>
  </reference>
  <reference>
    <citation>Qudeimat MA, Fayle SA. The use of space maintainers at a UK pediatric dentistry department. ASDC J Dent Child. 1999 Nov-Dec;66(6):383-6.</citation>
    <PMID>10656119</PMID>
  </reference>
  <reference>
    <citation>Ronnerman A, Thilander B. A longitudinal study on the effect of unilateral extraction of primary molars. Scand J Dent Res. 1977 Jul;85(5):362-72. doi: 10.1111/j.1600-0722.1977.tb01516.x.</citation>
    <PMID>268677</PMID>
  </reference>
  <reference>
    <citation>Ronnerman A, Thilander B. Facial and dental arch morphology in children with and without early loss of deciduous molars. Am J Orthod. 1978 Jan;73(1):47-58. doi: 10.1016/0002-9416(78)90101-x. No abstract available.</citation>
    <PMID>271472</PMID>
  </reference>
  <reference>
    <citation>Talekar BS, Rozier RG, Slade GD, Ennett ST. Parental perceptions of their preschool-aged children's oral health. J Am Dent Assoc. 2005 Mar;136(3):364-72; quiz 381. doi: 10.14219/jada.archive.2005.0179.</citation>
    <PMID>15819352</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yara Abdelwahab AbdelHameed</investigator_full_name>
    <investigator_title>Principle investigaror</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 28, 2018</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>March 8, 2018</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>April 22, 2018</submitted>
    <returned>October 18, 2018</returned>
    <submitted>October 18, 2018</submitted>
    <returned>November 27, 2018</returned>
    <submitted>November 29, 2018</submitted>
    <returned>March 14, 2019</returned>
    <submitted>March 25, 2019</submitted>
    <returned>June 20, 2019</returned>
    <submitted>July 10, 2019</submitted>
    <returned>August 19, 2019</returned>
    <submitted>September 2, 2019</submitted>
    <returned>September 27, 2019</returned>
    <submitted>October 8, 2019</submitted>
    <returned>October 31, 2019</returned>
    <submitted>November 11, 2019</submitted>
    <returned>November 29, 2019</returned>
    <submitted>December 12, 2019</submitted>
    <returned>December 31, 2019</returned>
    <submitted>January 15, 2020</submitted>
    <returned>January 24, 2020</returned>
    <submitted>February 12, 2020</submitted>
    <returned>February 24, 2020</returned>
    <submitted>March 17, 2020</submitted>
    <returned>March 30, 2020</returned>
    <submitted>April 21, 2020</submitted>
    <returned>May 8, 2020</returned>
  </pending_results>
  <!-- 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/NCT03027765
org study id: Space Maintainers
nct id: NCT03027765
lead sponsor: 
has dmc: No
The purpose of the study is

        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and
           Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

        -  To assess the knowledge, attitude and awareness of constructed space maintainers for
           pediatric patients' guardians at Pediatric Dentistry and Dental Public Health
           Department, Faculty of Oral and Dental Medicine, Cairo University.

      and

      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space
      maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty
      of Oral and Dental Medicine, Cairo University.
The purpose of the study is

        -  To determine the Prevalence of constructed space maintainers at Pediatric Dentistry and
           Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo University.

        -  To assess the knowledge, attitude and awareness of constructed space maintainers for
           pediatric patients' guardians at Pediatric Dentistry and Dental Public Health
           Department, Faculty of Oral and Dental Medicine, Cairo University.

      and

      - To assess the knowledge, attitude and practice of pediatric dentists towards use of space
      maintainers in children, at Pediatric Dentistry and Dental Public Health Department, Faculty
      of Oral and Dental Medicine, Cairo University.

      PO1:

      Population:

      Egyptian children with constructed space maintainers and their guardians attending Pediatric
      Dentistry and Dental Public Health Department, Faculty of Oral and Dental Medicine, Cairo
      University.

      Outcome1:

      Prevalence of constructed space maintainers Knowledge, attitude and awareness of constructed
      space maintainers for pediatric patients' guardians.

      PO2

      Population2:

      Pediatric dentists at Pediatric Dentistry and Dental Public Health Department, Faculty of
      Oral and Dental Medicine, Cairo University.

      Outcome2:

      knowledge, attitude and practice of pediatric dentists towards the use of the space
      maintainers.
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of constructed space maintainers
time frame: 6 months
description: Device for measurement through Visual examination and unit is Binary (Yes, No) and MCQ
arm group label: Egyptian children
description: Population1:
Egyptian children with constructed space maintainers at Cairo University.
arm group label: Pediatric dentists
description: Population2:
Pediatric dentists at Cairo University.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sherine Ezz Eldin Taha, Professor
role: Study Director
affiliation: Cairo University
last name: Yara AbdulWahab AbdulHameed Moawad, bachelor
phone: +201116108317
email: yaramoawad@rocketmail.com
last name: Fatma Korany, Lecturer
phone: 01006753265
email: fatmadent@hotmail.com
citation: Ari T. Follow-up problems with fixed appliances in pediatric dentistry. N Y State Dent J. 2015 Mar;81(2):16-20.
PMID: 25928968
citation: Asiry MA. Occlusal Status among 12-16 Year-Old School Children in Riyadh, Saudi Arabia. J Int Oral Health. 2015 May;7(5):20-3.
PMID: 26028897
citation: Baroni C, Franchini A, Rimondini L. Survival of different types of space maintainers. Pediatr Dent. 1994 Sep-Oct;16(5):360-1. No abstract available.
PMID: 7831141
citation: Brothwell DJ. Guidelines on the use of space maintainers following premature loss of primary teeth. J Can Dent Assoc. 1997 Nov;63(10):753, 757-60, 764-6.
PMID: 9401297
citation: Dhar V, Jain A, Van Dyke TE, Kohli A. Prevalence of gingival diseases, malocclusion and fluorosis in school-going children of rural areas in Udaipur district. J Indian Soc Pedod Prev Dent. 2007 Apr-Jun;25(2):103-5. doi: 10.4103/0970-4388.33458.
PMID: 17660647
citation: Dogan MC, Dogan SK, Kendi E. Complications of pediatric denture misuse: a case report. Oral Health Prev Dent. 2005;3(2):127-30.
PMID: 16173390
citation: Green J. Mind the gap: Overview of space maintaining appliances. Dent Nurs 2015; 11(1):24-7.
citation: Kapala JT. Interceptive orthodontics and management of space problems. In: Braham RL, Morris ME. Textbook of Pediatric Dentistry, Eds. Baltimore, London, William & Wilkins Co. 1980: pp 320-356.
citation: Keski-Nisula K, Hernesniemi R, Heiskanen M, Keski-Nisula L, Varrela J. Orthodontic intervention in the early mixed dentition: a prospective, controlled study on the effects of the eruption guidance appliance. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):254-60; quiz 328.e2. doi: 10.1016/j.ajodo.2006.05.039.
PMID: 18249292
citation: Laing E, Ashley P, Naini FB, Gill DS. Space maintenance. Int J Paediatr Dent. 2009 May;19(3):155-62. doi: 10.1111/j.1365-263X.2008.00951.x.
PMID: 19385999
citation: Leite-Cavalcanti A,de Alencar, Benzerra PK,Garcia A., Prevalence of early loss of primary molars in school children in Brazil. Pak Oral Dent J 2008; 28:113-6.
citation: Petrunov V. Epidemiological research of malocclusions and the need of orthodontic treatment among the Bulgarians in the mixed to permanent dentition period, Disertation, Sofia 2012, p.62
citation: Qudeimat MA, Fayle SA. The use of space maintainers at a UK pediatric dentistry department. ASDC J Dent Child. 1999 Nov-Dec;66(6):383-6.
PMID: 10656119
citation: Ronnerman A, Thilander B. A longitudinal study on the effect of unilateral extraction of primary molars. Scand J Dent Res. 1977 Jul;85(5):362-72. doi: 10.1111/j.1600-0722.1977.tb01516.x.
PMID: 268677
citation: Ronnerman A, Thilander B. Facial and dental arch morphology in children with and without early loss of deciduous molars. Am J Orthod. 1978 Jan;73(1):47-58. doi: 10.1016/0002-9416(78)90101-x. No abstract available.
PMID: 271472
citation: Talekar BS, Rozier RG, Slade GD, Ennett ST. Parental perceptions of their preschool-aged children's oral health. J Am Dent Assoc. 2005 Mar;136(3):364-72; quiz 381. doi: 10.14219/jada.archive.2005.0179.
PMID: 15819352
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yara Abdelwahab AbdelHameed
investigator title: Principle investigaror
mesh term: Tooth Loss
sharing ipd: No
submitted: February 28, 2018
submission canceled: Unknown
submitted: March 8, 2018
submission canceled: Unknown
submitted: April 22, 2018
returned: October 18, 2018
submitted: October 18, 2018
returned: November 27, 2018
submitted: November 29, 2018
returned: March 14, 2019
submitted: March 25, 2019
returned: June 20, 2019
submitted: July 10, 2019
returned: August 19, 2019
submitted: September 2, 2019
returned: September 27, 2019
submitted: October 8, 2019
returned: October 31, 2019
submitted: November 11, 2019
returned: November 29, 2019
submitted: December 12, 2019
returned: December 31, 2019
submitted: January 15, 2020
returned: January 24, 2020
submitted: February 12, 2020
returned: February 24, 2020
submitted: March 17, 2020
returned: March 30, 2020
submitted: April 21, 2020
returned: May 8, 2020