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Completed

NCT Number: NCT06934434

Evaluation of Familial Mediterranean Fever Impact on Oral and Dental Health in Children and Adolescents

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.

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Key information

Conditions

FMF Behavior Bruxism Habits Stomatognathic Diseases Tooth Diseases

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry,

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FMF Study Group

Other

In the study group consisting of children with FMF, 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 determined.

Control Group

Other

In the control group consisting of healthy children, 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 determined.

Primary outcomes

  1. DMFT index

    Time frame: 3 months

    To determine the DMFT index score, decayed teeth in permanent teeth are indicated as "D", lost teeth extracted due to decay are indicated as "M", and filled teeth are indicated as "F". The DMFT index is calculated by adding the D, M, F values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected.

  2. dft index

    Time frame: 3 months

    The dft Index is the calculated form of the DMFT index for primary teeth. When calculating the dft group index, missing teeth are not included in the calculation. Because it is difficult to diagnose the reason for the loss of primary teeth and there is a high probability of error. For this reason, the number of decayed and filled teeth is calculated during the examination. Decayed teeth are indicated with "d" and filled teeth with "f". The dft index is calculated by adding the d and f values and dividing them by the total number of permanent teeth. An increase in the calculated scores indicates that oral and dental health is negatively affected

  3. Saliva pH

    Time frame: 3 months

    Salivary pH was measured using pH indicator strips. A low pH (<6.5) indicates an acidic environment and increases the risk of tooth demineralization and caries, whereas a high pH (>7.5) indicates an alkaline state, which may be linked to decreased bacterial activity but may also indicate systemic conditions.

  4. Unstimulated salivary flow rate

    Time frame: 3 months

    Unstimulated salivary flow rate is measured by collecting unstimulated saliva over a period of time and calculating the volume per minute. A low flow rate (<0.1 mL/min) indicates hyposalivation, which increases the risk of caries and oral infection, while a high flow rate may be associated with conditions such as gastroesophageal reflux or medication effects.

  5. Saliva buffering capacity

    Time frame: 3 months

    Saliva buffering capacity was measured using the GC Saliva Buffer Kit, which uses a scoring system based on color changes. A low buffering capacity indicates a higher risk of dental caries and enamel demineralization, whereas a high buffering capacity indicates better protection against acid attacks in the oral environment.

  6. Simplified Oral Hygiene Index (OHI-S)

    Time frame: 3 months

    The Simplified Oral Hygiene Index (OHI-S) assesses oral cleanliness by measuring debris and calculus accumulation on selected tooth surfaces. Higher scores indicate poorer oral hygiene, while lower scores suggest better maintenance.

  7. The Modified Gingival Index (MGI)

    Time frame: 3 months

    The Modified Gingival Index (MGI) evaluates gingival inflammation without probing, based on visual inspection. Higher scores reflect increased inflammation and potential periodontal issues.

Sponsors and collaborators

Lead sponsor

Ozge Gungor

Other

Collaborators

  • Akdeniz University

Registry information

Official study title

Evaluation of Familial Mediterranean Fever (FMF) Impact on Oral and Dental Health in Children and Adolescents

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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