HypodontiaNCT03445026
Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors Study
An observational study of Hypodontia, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Hypodontia
- What is being tested?
- dental panorama
- How many people
- 144 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Subjects will be selected from 57357 Children Cancer Hospital records according to inclusion and exclusion criteria and contacted to attend.
Who may be able to join
- Aged 4 years or less when they first started their antineoplastic chemotherapy
- Both genders
- Able to cooperate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo university
Cairo
Hassan Ahmed, (+202) 23634965, cebd@dentistry.cu.edu.eg
About this study
Official title: Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors: A Cross Sectional Study
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.
- Conditions
- Hypodontia
- Being tested
- dental panorama
- Medical subject headings
- Anodontia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental panoramaDiagnostic test
radiographic examination
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypodontia
missing not formed teeth
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Jan 2018
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypodontiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Adel Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445026
- Sponsor's protocol ID
- CEBD-CU-2018-02-20
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 26 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: BDS,MFDS RCSEd Dentist at 57357 Children Cancer Hospital Egypt
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Hypodontia After Chemotherapy in Childhood Cancer Survivors: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03445026
- Acronym / sponsor ID
- CEBD-CU-2018-02-20
- Conditions
- Hypodontia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be selected from 57357 Children Cancer Hospital records according to inclusion and exclusion criteria and contacted to attend.
Key inclusion criteria (3 listed)
- Aged 4 years or less when they first started their antineoplastic chemotherapy
- Both genders
- Able to cooperate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental panoramaradiographic examination | Diagnostic test | – |
Primary outcome
Hypodontia
Time frame: 1 year
missing not formed teeth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: Undecided. BDS,MFDS RCSEd Dentist at 57357 Children Cancer Hospital Egypt
Related trials for Hypodontia
Not yet recruitingObservational study
Improving Decision-Making for Missing Upper Front Teeth
Hypodontia, Decision Making ,Shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypodontia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypodontia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.