NCT03445026

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 26, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

February 20, 2018

Last Update Submit

February 23, 2018

Conditions

Hypodontia

Outcome Measures

Primary Outcomes (1)

  • Hypodontia

    missing not formed teeth

    1 year

Interventions

dental panoramaDIAGNOSTIC_TEST

radiographic examination

Eligibility Criteria

Age6 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be selected from 57357 Children Cancer Hospital records according to inclusion and exclusion criteria and contacted to attend.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.Sc,MFDS RCSEd,Dentist at 57357 Children Cancer Hospital

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 26, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

February 26, 2018

Record last verified: 2018-02

Locations

EG(1)