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

Recruiting now · Not applicable

Conditions studied: Dental Caries, Dental Caries in Children

In brief

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 reference; baseline saliva sampling only). Saliva samples will be collected at T0 (baseline), T1 (30 minutes post-application), and T2 (1 month). Unstimulated whole saliva will be collected, centrifuged at 5,000 g for 10 minutes at 4°C, and stored at -80°C. IL-6, MMP-8, MMP-9, and TIMP-1 levels will be measured using CE-marked/FDA-approved human saliva ELISA kits.

Key facts

Study ID: NCT07609797
Run by: Gül Keskin
People needed: 80
Starts: 2026-05-15
Expected to finish: 2027-06-30
Last updated by the study team: 2026-06-02

Who can join

Age: 6 and older, up to 8. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Alanya Alaaddin Keykubat University, Faculty of Dentistry — Alanya, Antalya, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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