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The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries

RecruitingNAAges 6 Years - 8 YearsAllGül Keskin
NCT07609797 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study aims to compare salivary IL-6, MMP-8, MMP-9, and TIMP-1 levels between healthy children and caries-active children, and to evaluate the effects of 5% sodium fluoride (NaF) varnish and 2% chlorhexidine (CHX) used in caries prevention on these biomarkers. The study will be conducted at Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Pediatric Dentistry. Informed consent will be obtained from children and their parents/guardians. Investigator calibration will be performed using Cohen's kappa method prior to data collection. Sample size was calculated assuming 80% power (1-β = 0.80), α = 0.05, and Cohen's d ≈ 0.8, resulting in 20 participants per group using G\*Power 3.1 software. Study groups: Group A: 5% NaF varnish. Group B: 2% CHX + 5% NaF varnish. Group C: Standard oral hygiene education (negative control). Group D: Caries-free children (biological

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children aged 6-8 years with all first permanent molars erupted * For active caries groups (Groups A, B, C): participants must meet at least one of the following criteria: dmft ≥ 6, or presence of at least one active caries lesion with an ICDAS code ≥ 3, or clinical evidence of active caries on ≥ 10 surfaces * For the dmft = 0 reference group (Group D): all surfaces caries-free and non-high-risk individuals (ICDAS II = 0); only baseline (T0) saliva sampling will be performed * No professional topical fluoride application or continuous CHX use within the past 3 months * No systemic chronic disease, immunodeficiency, or severe neuromotor disorder * No gingival redness, swelling, or bleeding * Written parental informed consent obtained Exclusion Criteria: * Known allergy to fluoride compounds or varnish components * Behavioral problems that would prevent safe cooperation during application * Regular antibiotic use within the past 1 month * Individuals with infectious diseases * Those at high risk of endocarditis * History of substance dependence * Epilepsy * Renal failure or immunosuppression
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What it tests

  • 5% Sodium Fluoride Varnish
  • 2% Chlorhexidine Pre-Treatment + 5% NaF Varnish
  • Standard Oral Hygiene Education
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Where

1 site
Alanya Alaaddin Keykubat University, Faculty of Dentistry
Alanya, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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