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Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445026
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Adel Mahmoud, Cairo University

Brief Summary:
This study aims to provide information on the frequency of hypodontia in children cancer survivors receiving chemotherapy before 4 years of age.Patients who met the eligibility criteria will be given a structured questionnaire to fill followed by a radiographic examination (dental panorama) for confirmation and standardization of the results.

Condition or disease Intervention/treatment
Hypodontia Diagnostic Test: dental panorama

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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors: A Cross Sectional Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: dental panorama
    radiographic examination


Primary Outcome Measures :
  1. Hypodontia [ Time Frame: 1 year ]
    missing not formed teeth



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Subjects will be selected from 57357 Children Cancer Hospital records according to inclusion and exclusion criteria and contacted to attend.
Criteria

Inclusion Criteria:

  • Aged 4 years or less when they first started their antineoplastic chemotherapy
  • Both genders
  • Able to cooperate

Exclusion Criteria:

  • Children with known family history of hypodontia
  • Children with any associated developmental anomalies (eg, ectodermal dysplasia, cleft lip or palate and Down syndrome)
  • Children who received radiotherapy
  • Children with previous loss of teeth due to trauma, caries, periodontal disease or extraction 5- Children who received bone marrow transplantation 6-Parents/patients unwilling to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445026


Locations
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Egypt
Cairo university Recruiting
Cairo, Egypt
Contact: Hassan Ahmed    (+202) 23634965    cebd@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University

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Responsible Party: Ghada Adel Mahmoud, B.D.Sc,MFDS RCSEd,Dentist at 57357 Children Cancer Hospital, Cairo University
ClinicalTrials.gov Identifier: NCT03445026    
Other Study ID Numbers: CEBD-CU-2018-02-20
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: BDS,MFDS RCSEd Dentist at 57357 Children Cancer Hospital Egypt

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anodontia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities