Mouth DiseasesNCT04074395
Oral and Maxillofacial Pathology in Pediatric Patients
An observational study of Mouth Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
determination of the relative frequency of oral and maxillofacial pathological lesions among the Egyptian children and compare it with the global reports. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Mouth Diseases
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2019to 2 Mar 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Biopsy records for children aged from 0 to 18 years
Who may be able to join
- Biopsy records for children aged from 0 to 18 years
Who cannot join
- Biopsy records for patients older than 18
- Incomplete record regarding age, gender, location
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Analysis of Oral and Maxillofacial Pathological Lesions in Egyptian Children
determination of the relative frequency of oral and maxillofacial pathological lesions among the Egyptian children and compare it with the global reports.
Read the detailed description
Oral and maxillofacial pathology in pediatric patients differs from the general population, as the nature of lesions in children changes with growth and development. Oral and maxillofacial pathology encompasses a wide spectrum of diseases, some of which (i.e. aphthous ulceration, geographic tongue, and herpes labialis) can be diagnosed on clinical presentation alone. For other soft tissue diseases and for pathology with bony components, incisional or excisional biopsy is mandatory to establish a definitive diagnosis .
Several studies illustrated that oral and maxillofacial pathology in pediatric populations varies based on the geographic location of the population as racial and environmental specificities and the lifestyle of each population may influence the prevalence of these diseases .
Although there is increasing literature regarding the incidence and prevalence of pediatric oral and maxillofacial pathology, there is no study investigating the range and frequency in Egyptian children.
- Conditions
- Mouth Diseases
- Keywords
- oral pathology
- Medical subject headings
- Mouth Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of oral and maxillofacial pathological lesions among Egyptian children
percentage of cases with oral pathological lesions
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start2 Oct 2019
- Primary completion2 Feb 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth DiseasesStudies 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohsen Aly, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074395
- Sponsor's protocol ID
- Oral pathology
- Status last verified
- Jul 2020
- First submitted
- 28 Aug 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Oral and Maxillofacial Pathological Lesions in Egyptian Children
- ClinicalTrials.gov ID
- NCT04074395
- Acronym / sponsor ID
- Oral pathology
- Conditions
- Mouth Diseases
- Keywords
- oral pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 2 Feb 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 30 Aug 2019 (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.
determination of the relative frequency of oral and maxillofacial pathological lesions among the Egyptian children and compare it with the global reports.
Detailed description
Oral and maxillofacial pathology in pediatric patients differs from the general population, as the nature of lesions in children changes with growth and development. Oral and maxillofacial pathology encompasses a wide spectrum of diseases, some of which (i.e. aphthous ulceration, geographic tongue, and herpes labialis) can be diagnosed on clinical presentation alone. For other soft tissue diseases and for pathology with bony components, incisional or excisional biopsy is mandatory to establish a definitive diagnosis .
Several studies illustrated that oral and maxillofacial pathology in pediatric populations varies based on the geographic location of the population as racial and environmental specificities and the lifestyle of each population may influence the prevalence of these diseases .
Although there is increasing literature regarding the incidence and prevalence of pediatric oral and maxillofacial pathology, there is no study investigating the range and frequency in Egyptian children.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Biopsy records for children aged from 0 to 18 years
Key inclusion criteria (1 listed)
- Biopsy records for children aged from 0 to 18 years
Key exclusion criteria (2 listed)
- Biopsy records for patients older than 18
- Incomplete record regarding age, gender, location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of oral and maxillofacial pathological lesions among Egyptian children
Time frame: one month
percentage of cases with oral pathological lesions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mouth Diseases, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of oral and maxillofacial pathological lesions among Egyptian children (time frame: one month). 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 14 Jul 2020.