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Official title The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries
ClinicalTrials.gov ID: NCT07609797
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 8. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- No professional topical fluoride application or continuous CHX use within the past 3 months
- No systemic chronic disease, immunodeficiency, or severe neuromotor disorder
You likely can't join 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Alanya, Antalya, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 8 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alanya, Antalya, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.