ClinicalTrials.gov record NCT07248059

Prevalence of Oral Findings in Egyptian Patients Diagnosed With Familial Mediterranean Fever

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Prevalence of Oral Findings in Egyptian Patients Diagnosed With Familial Mediterranean Fever: A Hospital-Based Cross-sectional Study

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age6 years old to 15 years old
SexAll
LocationEgypt
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This cross-sectional observational study looks at how often certain oral findings occur in Egyptian children aged 6 to 15 with a confirmed diagnosis of Familial Mediterranean Fever (FMF). Each participant has one standardized clinical oral exam and a review of their medical record. Children with other systemic diseases or who cannot cooperate are excluded.

What it is studying. How frequently specific oral features (for example: high-arched palate, enamel defects, macroglossia, recurrent oral ulcers, short philtrum) are present in children with FMF, recorded as yes/no.

What the researchers hope to learn. To estimate the prevalence of selected oral findings among children with FMF; to document which oral anomalies occur in this group; and to provide baseline data that could inform future diagnostic research or clinical awareness.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participation involves a single cross-sectional clinic visit. During that visit a clinician will perform a clinical oral examination using a standardized dental chart and the study team will review the child's medical record. The exam will record presence or absence (yes/no) of oral findings such as high-arched palate, enamel defects, macroglossia, recurrent oral ulcers, and short philtrum. The registry lists no additional procedures beyond the oral exam and record review.

How the study is structured. An observational, single-visit (cross-sectional) study. Participants receive a standardized clinical oral examination and the study team reviews medical records. Oral findings are recorded as present or absent. No treatments or interventions are given by the study.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Important dates

Study start
December 2025 (estimated)
Primary completion
Oct 30, 2026 (estimated)
Study completion
Jul 30, 2027 (estimated)
Target enrollment
359 participants (estimated)
Last updated on registry
Nov 25, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Cairo University
Principal investigator
Amr Mahmoud Almorsy Ahmed, MSc candidate at the Oral Medicine and Periodontology department, Faculty of dentistry, Cairo university
Cairo University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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