Effect of fluoride varnish and chlorhexidine on saliva biomarkers in children with and without active caries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares salivary biomarkers (IL-6, MMP-8, MMP-9, TIMP-1) between healthy children and those with active caries. Participants are children aged 6-8 and are assigned to one of four groups: 5% sodium fluoride varnish, 2% chlorhexidine plus 5% fluoride varnish, standard oral hygiene education, and a caries-free reference group for baseline sampling. Saliva samples are collected at baseline and after follow-up to evaluate biomarker changes. The trial is conducted at Alanya Alaaddin Keykubat University, with investigator calibration and power-based sample size planning. Informed consent is obtained from guardians and participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Alanya Alaaddin Keykubat University, Faculty of Dentistry
  Alanya, Antalya, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: GÜL KESKİN, DDS, PhD
• Email: gul.keskin@alanya.edu.tr
• Phone: 905444468857

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.