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CompletedNCT06934434Updated Apr 18, 2025

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

An interventional study of FMF Study Group and control group in FMF, sponsored by Ozge Gungor. Completed at 1 site in Turkey. Open to participants aged 6 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Ozge Gungor · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Feb 2021, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
6 Years to 15 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 66 studies in Bruxism with a site in Turkey — 11 open to participants now, 13 under way, none of them phase 3. Bruxism · Turkey.

Enrollment
3rd of 41
90 · median 36
Started
2021
with 4 others
No phase
39 of 66
5 open now
Registered
31st of 66
by date

Among the 66 studies in Bruxism with a site in Turkey, this one is the 3rd largest by enrollment of the 41 interventional ones, is one of 5 that started in 2021, is one of 39 with no phase, and was the 31st registered.

By phase

66 studies; the count open now beside each. This study's row is marked.

No phasethis study39 · 5 open
Observational25 · 4 open
Phase 11 · 1 open
Phase 41 · 1 open

By the year they started

First in 2017; this study’s year is marked. 5 started in 2021.

Size and results

Median enrollment 36 across the 41 interventional studies, 76 across the 25 observational. Of the 52 that completed or were terminated, 2 (4%) have results posted.

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02

Study 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.

Read the 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.

03

Conditions studied

  • FMF

Browse trials for

Keywords

  • FMF
  • DMFT
  • Saliva
  • bruxism
  • Oral health
04

Who can participate

Ages eligible
6 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Study group with FMF

    The study group was named 'Study group with FMF'.

    Other: FMF Study Group

  • Experimental
    Healthy control group

    The control group consisting of healthy participants was called 'Healthy control group'.

    Other: control group

Interventions

  • OtherFMF Study Group

    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.

  • Othercontrol group

    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.

06

What researchers measure

Primary outcomes

  1. DMFT index

    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.

    Time frame: 3 months

  2. dft index

    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

    Time frame: 3 months

  3. Saliva pH

    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.

    Time frame: 3 months

  4. Unstimulated salivary flow rate

    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.

    Time frame: 3 months

  5. Saliva buffering capacity

    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.

    Time frame: 3 months

  6. Simplified Oral Hygiene Index (OHI-S)

    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.

    Time frame: 3 months

  7. The Modified Gingival Index (MGI)

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

    Time frame: 3 months

07

Study locations

1 site
  • Akdeniz University Faculty of Dentistry, Department of Pediatric Dentistry,
    Antalya, Konyaaltı 07058, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2021 to primary completion in May 2021, 3 months.

Of 59 non-industry interventional studies with no phase under Bruxism, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's 3 months is below that.

Counting every sponsor, half of 60 studies reached it within 7 months; a quarter within 3 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2025
First posted
Apr 18, 2025
StartActual
Feb 5, 2021
Primary completionActual
May 18, 2021
CompletionActual
Mar 22, 2022
Last update
Apr 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06934434
Lead sponsor
Ozge Gungor
Collaborators
Akdeniz University
Responsible party
Ozge Gungor (pHd, DDS, Assoc. Prof. Dr. Pediatric Dentist, Akdeniz University) — Sponsor-investigator
First posted
Apr 18, 2025
Start date
Feb 5, 2021
Primary completion
May 18, 2021
Completion
Mar 22, 2022
Last update
Apr 18, 2025

Study contacts

Özge GÜNGÖR, PhD, DDS, Assoc. Prof. Dr.
principal investigator · Akdeniz University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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