<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/NCT02999061</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2016-12-169</org_study_id>
    <nct_id>NCT02999061</nct_id>
  </id_info>
  <brief_title>Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition</brief_title>
  <official_title>Prevalence of Dental Caries in Preterm Birth Children Aged 2-5 Years in Primary Dentition: Across 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 to determine the prevalence of dental caries in preterm birth&#xD;
      children aged 2-5 years in primary dentition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to determine the prevalence of dental caries in preterm birth&#xD;
      children aged 2-5 years in primary dentition.&#xD;
&#xD;
      PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University&#xD;
      Children's Hospital &quot;Abo El-Rish&quot; at El-Monira, Cairo, Egypt.&#xD;
&#xD;
      Outcome (O) =prevalence of dental caries&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 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 dental caries.</measure>
    <time_frame>12 month</time_frame>
    <description>measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of oral hygiene .</measure>
    <time_frame>12 month</time_frame>
    <description>using a Questionnaire (binary' yes or no questions'):-&#xD;
record child brushing habits(once or twice)&#xD;
consumption of fluoridated water (yes/no).&#xD;
visits to dentists (yes/no)&#xD;
Also using a dental mirror and a probe to detect presence of plaque (plaque index) and presence of caries (dmf score).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of dietary habits</measure>
    <time_frame>12 month</time_frame>
    <description>questionnaire (binary &quot;yes/no questions&quot;)about the past and current feeding habits:-&#xD;
initial feeding of the child (breast or bottle answered yes/no)&#xD;
length of the breast feeding ( normal '0-2 years&quot; or prolonged &quot;&gt;2years&quot;)&#xD;
usage of bottle after weaning (yes/no). number of meals per day (one,two or three, answered in yes/no manner)&#xD;
number of snacks per day (one,two or three in yes/no answers).&#xD;
Also using a dental mirror and a probe to detect caries presence (dmf score), higher scores indicates faulty dietary habits.</description>
  </secondary_outcome>
  <enrollment type="Actual">383</enrollment>
  <condition>PreTerm Birth</condition>
  <eligibility>
    <study_pop>
      <textblock>
        population is limited to preterm birth children aged 2-5 years with primary teeth only ,&#xD;
        both genders are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 2-5 years old.&#xD;
&#xD;
          -  Presence of primary teeth only.&#xD;
&#xD;
          -  Children born preterm at gestational age of 6,7 and 8 month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with disability or mental disorders.&#xD;
&#xD;
          -  Children with immune compromising conditions.&#xD;
&#xD;
          -  Hospitalized and chronically ill children.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eman S Elmasry, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samah M Awad, Ass.Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University Children's Hospital &quot;Abo El-Rish&quot; at El-Monira</name>
      <address>
        <city>Cairo Governorate</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Brogardh-Roth S, Stjernqvist K, Matsson L. Dental behavioural management problems and dental caries prevalence in 3- to 6-year-old Swedish children born preterm. Int J Paediatr Dent. 2008 Sep;18(5):341-7. doi: 10.1111/j.1365-263x.2007.00884.x.</citation>
    <PMID>18802992</PMID>
  </reference>
  <reference>
    <citation>Cruvinel VR, Gravina DB, Azevedo TD, Bezerra AC, Toledo OA. Prevalence of dental caries and caries-related risk factors in premature and term children. Braz Oral Res. 2010 Jul-Sep;24(3):329-35. doi: 10.1590/s1806-83242010000300012.</citation>
    <PMID>20877971</PMID>
  </reference>
  <reference>
    <citation>Davenport ES, Litenas C, Barbayiannis P, Williams CE. The effects of diet, breast-feeding and weaning on caries risk for pre-term and low birth weight children. Int J Paediatr Dent. 2004 Jul;14(4):251-9. doi: 10.1111/j.1365-263X.2004.00557.x.</citation>
    <PMID>15242381</PMID>
  </reference>
  <reference>
    <citation>Seow WK, Lam JH, Tsang AK, Holcombe T, Bird PS. Oral Streptococcus species in pre-term and full-term children - a longitudinal study. Int J Paediatr Dent. 2009 Nov;19(6):406-11. doi: 10.1111/j.1365-263X.2009.01003.x. Epub 2009 Sep 1.</citation>
    <PMID>19732193</PMID>
  </reference>
  <reference>
    <citation>Lai PY, Seow WK, Tudehope DI, Rogers Y. Enamel hypoplasia and dental caries in very-low birthweight children: a case-controlled, longitudinal study. Pediatr Dent. 1997 Jan-Feb;19(1):42-9.</citation>
    <PMID>9048413</PMID>
  </reference>
  <reference>
    <citation>Rajshekar SA, Laxminarayan N. Comparison of primary dentition caries experience in pre-term low birth-weight and full-term normal birth-weight children aged one to six years. J Indian Soc Pedod Prev Dent. 2011 Apr-Jun;29(2):128-34. doi: 10.4103/0970-4388.84685.</citation>
    <PMID>21911951</PMID>
  </reference>
  <reference>
    <citation>Saraiva MC, Bettiol H, Barbieri MA, Silva AA. Are intrauterine growth restriction and preterm birth associated with dental caries? Community Dent Oral Epidemiol. 2007 Oct;35(5):364-76. doi: 10.1111/j.1600-0528.2006.00345.x.</citation>
    <PMID>17822485</PMID>
  </reference>
  <reference>
    <citation>Tanaka K, Miyake Y. Low birth weight, preterm birth or small-for-gestational-age are not associated with dental caries in young Japanese children. BMC Oral Health. 2014 Apr 14;14:38. doi: 10.1186/1472-6831-14-38.</citation>
    <PMID>24731399</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>July 23, 2017</last_update_submitted>
  <last_update_submitted_qc>July 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ohoud Tawfig ZainElabdeen</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>pre-term children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Premature Birth</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/NCT02999061
org study id: CEBC-CU-2016-12-169
nct id: NCT02999061
lead sponsor: 
has dmc: No
The purpose of the study is to determine the prevalence of dental caries in preterm birth
      children aged 2-5 years in primary dentition.
The purpose of the study is to determine the prevalence of dental caries in preterm birth
      children aged 2-5 years in primary dentition.

      PICO format:- Population (P) = preterm children aged 2-5 years attending Cairo University
      Children's Hospital "Abo El-Rish" at El-Monira, Cairo, Egypt.

      Outcome (O) =prevalence of dental caries
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of dental caries.
time frame: 12 month
description: measured by counting the number of participants affected by dental caries/total number of study sample X100 , measurement unit is a percentage (%)
measure: Assessment of oral hygiene .
time frame: 12 month
description: using a Questionnaire (binary' yes or no questions'):-
record child brushing habits(once or twice)
consumption of fluoridated water (yes/no).
visits to dentists (yes/no)
Also using a dental mirror and a probe to detect presence of plaque (plaque index) and presence of caries (dmf score).
measure: Assessment of dietary habits
time frame: 12 month
description: questionnaire (binary "yes/no questions")about the past and current feeding habits:-
initial feeding of the child (breast or bottle answered yes/no)
length of the breast feeding ( normal '0-2 years" or prolonged ">2years")
usage of bottle after weaning (yes/no). number of meals per day (one,two or three, answered in yes/no manner)
number of snacks per day (one,two or three in yes/no answers).
Also using a dental mirror and a probe to detect caries presence (dmf score), higher scores indicates faulty dietary habits.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eman S Elmasry, Professor
role: Study Director
affiliation: Cairo University
last name: Samah M Awad, Ass.Prof.
role: Study Director
affiliation: Cairo University
facility: 
country: Egypt
citation: Brogardh-Roth S, Stjernqvist K, Matsson L. Dental behavioural management problems and dental caries prevalence in 3- to 6-year-old Swedish children born preterm. Int J Paediatr Dent. 2008 Sep;18(5):341-7. doi: 10.1111/j.1365-263x.2007.00884.x.
PMID: 18802992
citation: Cruvinel VR, Gravina DB, Azevedo TD, Bezerra AC, Toledo OA. Prevalence of dental caries and caries-related risk factors in premature and term children. Braz Oral Res. 2010 Jul-Sep;24(3):329-35. doi: 10.1590/s1806-83242010000300012.
PMID: 20877971
citation: Davenport ES, Litenas C, Barbayiannis P, Williams CE. The effects of diet, breast-feeding and weaning on caries risk for pre-term and low birth weight children. Int J Paediatr Dent. 2004 Jul;14(4):251-9. doi: 10.1111/j.1365-263X.2004.00557.x.
PMID: 15242381
citation: Seow WK, Lam JH, Tsang AK, Holcombe T, Bird PS. Oral Streptococcus species in pre-term and full-term children - a longitudinal study. Int J Paediatr Dent. 2009 Nov;19(6):406-11. doi: 10.1111/j.1365-263X.2009.01003.x. Epub 2009 Sep 1.
PMID: 19732193
citation: Lai PY, Seow WK, Tudehope DI, Rogers Y. Enamel hypoplasia and dental caries in very-low birthweight children: a case-controlled, longitudinal study. Pediatr Dent. 1997 Jan-Feb;19(1):42-9.
PMID: 9048413
citation: Rajshekar SA, Laxminarayan N. Comparison of primary dentition caries experience in pre-term low birth-weight and full-term normal birth-weight children aged one to six years. J Indian Soc Pedod Prev Dent. 2011 Apr-Jun;29(2):128-34. doi: 10.4103/0970-4388.84685.
PMID: 21911951
citation: Saraiva MC, Bettiol H, Barbieri MA, Silva AA. Are intrauterine growth restriction and preterm birth associated with dental caries? Community Dent Oral Epidemiol. 2007 Oct;35(5):364-76. doi: 10.1111/j.1600-0528.2006.00345.x.
PMID: 17822485
citation: Tanaka K, Miyake Y. Low birth weight, preterm birth or small-for-gestational-age are not associated with dental caries in young Japanese children. BMC Oral Health. 2014 Apr 14;14:38. doi: 10.1186/1472-6831-14-38.
PMID: 24731399
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ohoud Tawfig ZainElabdeen
investigator title: principal investigator
mesh term: Dental Caries
mesh term: Premature Birth
sharing ipd: No