- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07609797
The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries (DentalCaries)
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.
Przegląd badań
Status
Szczegółowy opis
Biomarkers to Be Measured in the Study and Expected Benefits:Biomarkers to Be Measured in the Study and Expected Benefits:
Dental caries is a multifactorial infectious disease with high prevalence that affects a large proportion of the world's population. The fundamental pathogenesis of the disease is characterized by tissue destruction caused by complex and synergistic biological processes that arise from the interaction of acids-produced through the fermentation of dietary carbohydrates by bacteria-with susceptible host factors such as dental hard tissues and saliva. The body develops an inflammatory response against dental caries, which is characterized by infection and tissue destruction; the purpose of this response is to eliminate the agent that initiated the inflammation and to restore tissue homeostasis.
As a result of bacterial stimulation and recognition, odontoblasts, pulp tissue fibroblasts, and immune cells such as dendritic cells, macrophages, and neutrophils collectively produce a large number of molecules; these include cytokines and chemokines such as interleukin-1 beta (IL-1β), tumor necrosis factor alpha (TNF-α), interleukin-6 (IL-6), interleukin-8 (IL-8), and prostaglandins, which prolong the inflammatory state and thereby support the activation of innate and adaptive immune responses.
IL-6, produced by odontoblasts and immune cells, increases markedly in the inflamed pulp. IL-6 neutralizes bacterial cell wall components by enhancing the secretion of LBP (lipopolysaccharide-binding protein) and regulates the immune response by reducing pro-inflammatory cytokine production. It also contributes to edema formation by increasing vascular permeability. It has been reported that salivary IL-6 may serve as a potential biomarker for assessing caries severity.
As caries lesions progress toward the pulp, demineralization and collagen degradation in the dentin matrix accelerate. The decrease in pH exposes collagen fibers to proteolytic enzymes, facilitating the demineralization of the dentin matrix. This acidic environment also accelerates caries progression by increasing the activation of MMPs (zinc- and calcium-dependent endopeptidases). MMPs are classified into five subgroups based on their substrate specificity and structural similarities: collagenases, stromelysins, gelatinases, matrilysins, and membrane-type MMPs. These enzymes can be activated in an acidic environment or by lactate released by cariogenic bacteria. MMP-8 (neutrophil collagenase) can cleave triple-helical fibrillar collagens into characteristic 3/4 and 1/4 fragments. MMP-9 is a gelatinase capable of degrading type IV collagen. The activation of MMP-8 and MMP-9 plays a critical role in collagen degradation in dentin caries lesions.
The activity of MMPs, which play a central role in dentin collagen degradation, also stands out as an important target for maintaining tissue balance. The control of these enzymes is primarily achieved through tissue inhibitors of metalloproteinases (TIMPs). TIMP-1 and TIMP-2 are the primary regulators of MMP activity and effectively prevent excessive extracellular matrix (ECM) degradation . TIMP-2 exhibits strong inhibition of polymorphonuclear cell (PMN)-derived MMPs, while TIMP-1 demonstrates more pronounced inhibition of fibroblast-derived MMPs.
Inhibition of MMP activity is considered a potential strategy for slowing caries progression and preventing dentin erosion. In this context, sodium fluoride (NaF) and chlorhexidine (CHX) are cited in the literature as the principal agents capable of reducing MMP activity. NaF has been shown to inhibit the catalytic activity of recombinant MMP-8 and MMP-9. Similarly, CHX can largely prevent collagen degradation in demineralized dentin and can demonstrate long-lasting anti-MMP effects by binding electrostatically to the dentin matrix.
All of these findings demonstrate that inflammation can be objectively measured through both local and systemic biomarkers. The dynamic interaction between pro-inflammatory signals and matrix degradation, along with the endogenous inhibitors involved in this process, is of critical importance for the preservation of dentin tissue and the control of caries progression. However, studies that comprehensively reveal the molecular-level interactions of this axis, particularly in caries-active children, are limited in the literature. In this context, the aim of our study is to compare the biomarkers IL-6, MMP-8, MMP-9, and TIMP-1-representing the key components of the inflammation-matrix degradation axis-between healthy children and caries-active children, and to evaluate the effects of materials such as NaF and CHX used in caries prevention on these parameters.
Biomarker Analysis The levels of IL-6, MMP-8, MMP-9, and TIMP-1 in saliva samples will be evaluated using human saliva enzyme-linked immunosorbent assay (ELISA) kits. Biomarker analyses (ELISA) of the samples will be performed at the ALKU Faculty of Medicine Pharmacology Laboratory.
The obtained data will be statistically analyzed. Descriptive statistics: Quantitative variables will be expressed as mean ± standard deviation or median and interquartile range (IQR), and qualitative variables will be expressed as frequencies and percentages.
Between-group comparisons and within-group changes over time will be evaluated using appropriate parametric or non-parametric tests.
Results will be interpreted by correlating changes in salivary biomarker levels with clinical findings.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: GÜL KESKİN, DDS, PhD
- Numer telefonu: 905444468857
- E-mail: gul.keskin@alanya.edu.tr
Kopia zapasowa kontaktu do badania
- Nazwa: BİNNUR B ÖZDEMİR, DDS
- Numer telefonu: 905069033834
- E-mail: busra.ozdemir@alanya.edu.tr
Lokalizacje studiów
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Antalya
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Alanya, Antalya, Turcja (Türkiye), 07450
- Rekrutacyjny
- Alanya Alaaddin Keykubat University, Faculty of Dentistry
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Kontakt:
- GÜL KESKİN, DDS, PhD
- Numer telefonu: 905444468857
- E-mail: gul.keskin@alanya.edu.tr
-
Kontakt:
- BİNNUR B ÖZDEMİR, DDS
- Numer telefonu: 905069033834
- E-mail: busra.ozdemir@alanya.edu.tr
-
Główny śledczy:
- GÜL KESKİN, DDS, PhD
-
Pod-śledczy:
- BİNNUR B ÖZDEMİR, DDS
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Pod-śledczy:
- ERKAN MAYTALMAN, DDS, PhD
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 5% Sodium Fluoride (NaF) Varnish
Caries-active children aged 6-8 years.
Teeth are gently air-dried for 30 seconds under isolation with cotton rolls and aspirator.
Approximately 0.5 mL of 5% NaF varnish is applied to all teeth sequentially by quadrant starting from the upper jaw using an applicator tip and left in place for 1 minute.
Parents are instructed to restrict water and hard food intake for 1 hour post-application.
Saliva samples collected at T0, T1 and T2.
n=20.
|
Teeth are gently air-dried for 30 seconds under isolation with cotton rolls and aspirator.
Approximately 0.5 mL of 5% NaF varnish is applied to all tooth surfaces sequentially by quadrant starting from the upper jaw using an applicator tip and left in place for 1 minute.
Parents are instructed to restrict water and hard food intake for 1 hour post-application.
This is a routine preventive application; no off-label use is involved.
|
|
Eksperymentalny: 2% Chlorhexidine Pre-Treatment + 5% NaF Varnish
Caries-active children aged 6-8 years.
Teeth are gently air-dried for 30 seconds under isolation.
2% CHX is applied to the lesion/tooth surfaces using an applicator tip and left for 30 seconds.
Excess CHX is absorbed, an additional 30 seconds was allowed to pass.NaF varnish was then applied and left for 1 minute.
Precautions are taken to prevent CHX ingestion.
Parents are instructed to restrict water and hard food intake for 1 hour post-application.
Saliva samples collected at T0, T1 and T2.
n=20.
|
Following isolation and air-drying, 2% chlorhexidine solution is applied to the lesion/tooth surfaces using an applicator tip and left in place for 30 seconds.
Excess CHX is then absorbed.
Precautions are taken to prevent ingestion.
This pre-treatment is performed immediately prior to 5% NaF varnish application.
This is a routine preventive application; no off-label use is involved.
|
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Aktywny komparator: Standard Care / Oral Hygiene Education
Caries-active children aged 6-8 years.
No professional topical agent is applied.
Children and parents receive standardized oral hygiene education including twice-daily brushing with fluoride toothpaste, reduction of sugar frequency, and a brief parent information brochure.
Necessary treatment will be offered at the end of the study upon request (wait-list design).
Saliva samples collected at T0 and T2.
n=20.
|
Children and parents receive standardized oral hygiene education including instruction on twice-daily brushing with fluoride toothpaste, reduction of sugar intake frequency, and a brief parent information brochure.
No professional topical agent is applied.
Necessary treatment will be offered at the end of the study upon request (wait-list design).
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Brak interwencji: Caries-Free Healthy Control
Age- and sex-matched caries-free children (ICDAS II = 0, dmft = 0) aged 6-8 years.
No intervention is applied.
Clinical assessment (dmft/ICDAS) is performed and recorded.
Saliva sampling is performed at T0 only.
This group serves as a non-randomized biological reference group.
n=20.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Salivary MMP-8 Levels
Ramy czasowe: Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
Change in salivary matrix metalloproteinase-8 (MMP-8) concentration measured by ELISA from baseline (T0) to post-application (T1) and 1 month post-intervention (T2) , and comparison between caries-active and caries-free groups at baseline.
Unstimulated whole saliva samples will be analyzed using CE-marked/FDA-approved human saliva ELISA kits.
Results expressed as ng/mL.
|
Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
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Change in Salivary IL-6 Levels
Ramy czasowe: Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
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Change in salivary interleukin-6 (IL-6) concentration measured by ELISA from baseline (T0) to post-application (T1) and 1 month post-intervention (T2) , and comparison between caries-active and caries-free groups at baseline.
Unstimulated whole saliva samples will be collected, centrifuged at 5,000 g for 10 minutes at 4°C, stored at -80°C, and analyzed using CE-marked/FDA-approved human saliva ELISA kits.
Results expressed as pg/mL.
|
Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
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Change in Salivary MMP-9 Levels
Ramy czasowe: Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
Change in salivary matrix metalloproteinase-9 (MMP-9) concentration measured by ELISA from baseline (T0) to post-application (T1) and 1 month post-intervention (T2), and comparison between caries-active and caries-free groups at baseline.
Unstimulated whole saliva samples will be analyzed using CE-marked/FDA-approved human saliva ELISA kits.
Results expressed as ng/mL.
|
Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
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Change in Salivary TIMP-1 Levels
Ramy czasowe: Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
Change in salivary tissue inhibitor of metalloproteinase-1 (TIMP-1) concentration measured by ELISA from baseline (T0) to post-application (T1) and 1 month post-intervention (T2), and comparison between caries-active and caries-free groups at baseline.
Unstimulated whole saliva samples will be analyzed using CE-marked/FDA-approved human saliva ELISA kits.
Results expressed as ng/mL.
|
Baseline (T0), 30 minutes post-application (T1), 1 month post-intervention (T2)
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: GÜL KESKİN, DDS, PhD, Alanya Alaaddin Keykubat University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-KAEK-44
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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