- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248059
Prevalence of Oral Findings in Egyptian Patients Diagnosed With Familial Mediterranean Fever
November 21, 2025 updated by: Amr Mahmoud Almorsy Ahmed, Cairo University
Prevalence of Oral Findings in Egyptian Patients Diagnosed With Familial Mediterranean Fever: A Hospital-Based Cross-sectional Study
This is an observational descriptive cross-sectional study will be performed at the Collagen Diseases Clinic, Abu Elreesh Japanese Children's Hospital, Cairo, Egypt.
This study aims to Investigate and assess the prevalence of oral findings or lesions in Egyptian patients diagnosed with FMF
Study Overview
Status
Not yet recruiting
Detailed Description
Familial Mediterranean Fever (FMF) is a monogenic autoinflammatory disease and the most common of the periodic fever syndromes.
FMF patients usually present with recurrent episodes of fever.
They also suffer from abdominal, chest and joint pain due to serositis.
Patients may present with erysipelas, amyloidosis, and rarely, ophthalmic manifestations.
The oral cavity and related facial structures may also be affected.
Oral lesions such as: recurrent oral ulcers, macroglossia and high arched palate.
The prevalence of oral findings in FMF remains variable and underexplored.
An accurate examination is required for the early identification of FMF cases.
Diagnostic delay is common in FMF and complicated by incomplete clinical presentation and overlap in symptoms with other diseases.
So, Recognizing other signs and symptoms could be incorporated into diagnostic criteria of FMF for early diagnosis and treatment with improvement of quality of life.
This study will be performed at the Collagen Diseases Clinic, Abu Elreesh Japanese Children's Hospital, Cairo, Egypt.
Egyptian children aged 6 to 15 years, with a confirmed diagnosis of FMF will be enrolled and recruited consecutively either at their initial diagnosis or follow-up visits.
On the other hand, Children with other systemic diseases not related to FMF, children who are unable to cooperate or refuse to participate will be excluded from the study.
During this visit, data will be collected through clinical oral examination using a standardized dental chart, along with a review of their medical records.
The oral findings will be reported as binary data (yes / no).
Moreover, documenting such oral findings could provide an important baseline for identifying FMF-associated anomalies in the population.
Study Type
Observational
Enrollment (Estimated)
359
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amr Mahmoud Almorsy, MSc candidate
- Phone Number: 01060964113 01014346192
- Email: amr.almorsy@dentistry.cu.edu.eg
Study Contact Backup
- Name: Noha Adel Ibrahim, Lecturer
- Phone Number: 01014346192 01001381954
- Email: noha.adel@dentistry@cu.edu.eg
Study Locations
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Cairo, Egypt
- Collagen Diseases Clinic, Abu Elreesh Japanese Children's Hospital
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Contact:
- Amr Mahmoud Alshafaey, MSc student
- Phone Number: 01060964113 01014346192
- Email: amr.almorsy@dentistry.cu.edu.eg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Egyptian children aged 6 to 15 years, with a confirmed diagnosis of Familial Mediterranean Fever (FMF), attending the Collagen Diseases Clinic at Abu Elreesh Japanese Children's Hospital will be enrolled and recruited consecutively at a one point in time.
Description
Inclusion Criteria:
- Egyptian children aged 6 to 15 years
- Children with a confirmed diagnosis of Familial Mediterranean Fever (FMF)
- Children attending the Collagen Diseases Clinic at Abu Elreesh Japanese Children's Hospital.
Exclusion Criteria:
- Children with other systemic diseases not related to FMF
- Children who are unable to cooperate or refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Egyptian children with FMF
Egyptian children aged 6 to 15 years, with a confirmed diagnosis of Familial Mediterranean Fever (FMF), attending the Collagen Diseases Clinic at Abu Elreesh Japanese Children's Hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of Oral Findings in Egyptian patients Diagnosed with Familial Mediterranean Fever
Time Frame: At enrollment ( single cross-sectional visit)
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The data will be collected through clinical oral examination using a standardized dental chart, along with a review of their medical records.
The oral findings including high-arched palate, enamel defects, macroglossia, recurrent oral ulcers, and short philtrum will be reported as binary data (yes / no).
Binary data such as prevalence of oral manifestations will be reported as a proportion.
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At enrollment ( single cross-sectional visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fat'heya Mohamed Zahran, Professor, Cairo University
- Study Chair: noha adel ibrahim, lecturer, Cairo University
- Study Chair: Hend mohamed abu shaday, assistant professor, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2025
Primary Completion (Estimated)
October 30, 2026
Study Completion (Estimated)
July 30, 2027
Study Registration Dates
First Submitted
September 23, 2025
First Submitted That Met QC Criteria
November 21, 2025
First Posted (Actual)
November 25, 2025
Study Record Updates
Last Update Posted (Actual)
November 25, 2025
Last Update Submitted That Met QC Criteria
November 21, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMED 2-1-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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