Frequency of Hypodontia After Chemotherapy in Childhood C... | NCT03445026

Studies
Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors Study

NCT03445026

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 26, 2018Actual

Enrollment

144Estimated

Phase

Not provided

Conditions

Hypodontia

Interventions

dental panorama

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Feb 20, 2018

First Submission Date that Met QC Criteria

Feb 23, 2018

First Posted Date

Feb 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2018

Last Update Posted Date

Feb 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ghada Adel Mahmoud, B.D.Sc,MFDS RCSEd,Dentist at 57357 Children Cancer Hospital, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

144Estimated

Name	Type	Description	Arm Group Labels	Other Names
dental panorama	Diagnostic Test	radiographic examination

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypodontia	missing not formed teeth	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

BDS,MFDS RCSEd Dentist at 57357 Children Cancer Hospital Egypt

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000848	Anodontia

Ancestor Terms

ID	Term
D014071	Tooth Abnormalities
D018640	Stomatognathic System Abnormalities
D009057	Stomatognathic Diseases
D014076	Tooth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided