Clinical trial NCT06934434: Evaluation of Familial Mediterranean Fever Impact on Oral and Dental Health in Children and Adolescents
Official title: Evaluation of Familial Mediterranean Fever (FMF) Impact on Oral and Dental Health in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: FMF
Keywords: FMF
DMFT
Saliva
bruxism
Oral health
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Akdeniz University
First posted: 2025-04-18
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Aim: It is the clinical and radiological evaluation of oral hygiene, teeth and surrounding tissues in children and adolescents diagnosed with FMF and comparing the results with healthy individuals. Method: Our study included patients aged 6-15, 45 with FMF (study group) and 45 healthy (control group), who were referred from Akdeniz University Faculty of Medicine Pediatric Rheumatology Clinic and evaluated at Akdeniz University Faculty of Dentistry Pedodontics Clinic. MEFV gene mutations were investigated in the study group. After recording the demographic and clinical characteristics of both groups, intraoral examinations were performed and DMFT, dft, bruxism, tooth wear due to bruxism and gingival/plaque indexes were evaluated. Saliva pH, flow rate and buffering capacity were measured. Tooth age was determined by the Cameriere method, The mesio-distal dimensions of the teeth were measured on the plaster model.

Detailed description: In the study, DMFT, dft, bruxism, tooth wear due to bruxism, gingival index (MGI), plaque index (OHI-S), salivary pH, salivary flow rate, salivary buffering capacity, dental age, chronological age difference, mesio-distal dimensions of the teeth, and the presence of aphthous lesions were evaluated and compared between the study group consisting of children with FMF and the control group of healthy children.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with FMF, aged between 6-15 years, who were admitted/referred to the Pediatric Dentistry Department Clinic of Akdeniz University Faculty of Dentistry for oral and dental examination, and who agreed to participate in the study after being thoroughly informed both verbally and in writing.
* Patients with no systemic diseases other than FMF.
* Patients who have not used any systemic antibiotics or similar medications (e.g., antidepressants, psychiatric drugs) within the last 3 months.

Exclusion Criteria:

* Patients diagnosed with FMF, who were admitted/referred to the Pediatric Dentistry Department Clinic of Akdeniz University Faculty of Dentistry for oral-dental examination but declined to participate in the study after being thoroughly informed both verbally and in writing.
* Patients with any systemic disease other than FMF.
* Patients who have used systemic antibiotics or any other medications (e.g., antidepressants, psychiatric drugs) within the last 3 months.

Primary outcomes:
measure: DMFT index
timeFrame: 3 months
measure: dft index
timeFrame: 3 months
measure: Saliva pH
timeFrame: 3 months
measure: Unstimulated salivary flow rate
timeFrame: 3 months
measure: Saliva buffering capacity
timeFrame: 3 months
measure: Simplified Oral Hygiene Index (OHI-S)
timeFrame: 3 months
measure: The Modified Gingival Index (MGI)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry,
state: Konyaaltı
Study officials:
affiliation: Akdeniz University
name: Özge GÜNGÖR, PhD, DDS, Assoc. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: