Familial Mediterranean Fever (FMF ) and Oral FindingsNCT07248059
Prevalence of Oral Findings in Egyptian Patients Diagnosed With Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever (FMF ) and Oral Findings, run by Cairo University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF ) and Oral Findings
- How many people
- 359 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Children with other systemic diseases not related to FMF
- Children who are unable to cooperate or refuse to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amr Mahmoud Almorsy, MSc candidate contact
Egypt1 site
Collagen Diseases Clinic, Abu Elreesh Japanese Children's Hospital
Cairo
Amr Mahmoud Alshafaey, MSc student, 01014346192 ext. 01060964113, amr.almorsy@dentistry.cu.edu.eg
About this study
Official title: 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
Read the 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.
- Keywords
- FMF , Oral lesions
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Oral Findings in Egyptian patients Diagnosed with Familial Mediterranean Fever
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.
Measured: At enrollment ( single cross-sectional visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study startDec 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF ) and Oral FindingsStudies 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
- 359 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mahmoud Almorsy Ahmed, Cairo University
- Investigators
- Fat'heya Mohamed Zahran, Professor, Principal investigator, Cairo Universitynoha adel ibrahim, lecturer, Study chair, Cairo UniversityHend mohamed abu shaday, assistant professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248059
- Sponsor's protocol ID
- OMED 2-1-1
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Oral Findings in Egyptian Patients Diagnosed With Familial Mediterranean Fever: A Hospital-Based Cross-sectional Study
- ClinicalTrials.gov ID
- NCT07248059
- Acronym / sponsor ID
- OMED 2-1-1
- Keywords
- FMF , Oral lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 359 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 25 Nov 2025 (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 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
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with other systemic diseases not related to FMF
- Children who are unable to cooperate or refuse to participate
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
Prevalence of Oral Findings in Egyptian patients Diagnosed with Familial Mediterranean Fever
Time frame: At enrollment ( single cross-sectional visit)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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.
Amr Mahmoud Almorsy, MSc candidate contact
Fat'heya Mohamed Zahran, Professor principal investigator
Cairo University
noha adel ibrahim, lecturer study chair
Cairo University
Hend mohamed abu shaday, assistant professor study chair
Cairo University
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 Familial Mediterranean Fever (FMF ) and Oral Findings, 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 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: opening soon, as of the sponsor's last update on 25 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr Mahmoud Almorsy, MSc candidate (01014346192 ext. 01060964113, amr.almorsy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Oral Findings in Egyptian patients Diagnosed with Familial Mediterranean Fever (time frame: At enrollment ( single cross-sectional visit)). 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 25 Nov 2025.