NCT07609797 The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries
| NCT ID | NCT07609797 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gül Keskin |
| Condition | Dental Caries |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-05-15 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
GÜL KESKİN, DDS, PhD
STUDY DIRECTOR
Alanya Alaaddin Keykubat University
Frequently Asked Questions
Who can join the NCT07609797 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 8 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07609797 currently recruiting?
Yes, NCT07609797 is actively recruiting participants. Contact the research team at gul.keskin@alanya.edu.tr for enrollment information.
Where is the NCT07609797 trial being conducted?
This trial is being conducted at Alanya, Turkey (Türkiye).
Who is sponsoring the NCT07609797 clinical trial?
NCT07609797 is sponsored by Gül Keskin. The principal investigator is GÜL KESKİN, DDS, PhD at Alanya Alaaddin Keykubat University. The trial plans to enroll 80 participants.