Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

Study Overview
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Brief Summary
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The study was carried out in 88 children with severe early childhood caries (dmfs≥age +1) who were referred to the investigators' clinic. Patients who completed dental treatment under general anesthesia in a single session, were included to the study. Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child. The groups were as follows; Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22), Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE) (n = 22), Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22), MI Varnish containing 5% Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish (GC) (n = 22). Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples before general anaesthesia; one month after treatment and three months after treatment.

Detailed Description
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Duraphat (Colgate), which we used as a positive control group in our study, contains only 5% sodium fluoride. It has been reported in studies that Duraphat is effective in remineralization. Clinpro ™ White Varnish, another topical varnish in this study,was reported to be effective for caries prevention in pre-school children. One of the varnishes we evaluate in the study, Embrace™ Varnish, contains 5% sodium fluoride with xylitol-coated calcium and phosphate. According to the manufacturer, the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva. Saliva dissolves the xylitol and releases the calcium and phosphate ions, which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish, in the fourth group containing 5% sodium fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP) had a high release of calcium and fluoride ions.

Official Title
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Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries

Conditions
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Early Childhood Caries

Intervention / Treatment
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* Drug: Sodium Fluoride
* Drug: Sodium Fluoride with TCP
* Drug: Sodium Fluoride with CXP
* Drug: Sodium Fluoride with CPP-ACP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of healthy children with severe early childhood caries, younger than 6 years in the primary dentition Exclusion Criteria: history of any chronic disease, use of any drugs that reduce salivary flow or antibiotics in the last 4 weeks, use of systemic fluoride tablets

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 72 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Fluoride<br>Varnish containing 5% Sodium Fluoride, was applied to all remaining teeth of each child after dental treatment under general anaesthesia. | Drug: Sodium Fluoride<br> <br> * Other names: Colgate Duraphat varnish;|
| Experimental: Sodium Fluoride with TCP<br>Varnish containing 5% Sodium Fluoride with tricalcium phosphate (TCP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. | Drug: Sodium Fluoride with TCP<br> <br> * Other names: Clinpro ™ White Varnish 3M ESPE;|
| Experimental: Sodium Fluoride with CXP<br>Varnish containing 5% Sodium Fluoride with Xylitol-coated Calcium and Phosphate (CXP) ,varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. | Drug: Sodium Fluoride with CXP<br> <br> * Other names: Embrace ™ Varnish Pulpdent;|
| Experimental: Sodium Fluoride with CPP-ACP<br>Varnish containing 5% Sodium Fluoride with casein phosphopeptide amorphous calcium phosphate (CPP-ACP), varnish was applied to all remaining teeth of each child after dental treatment under general anaesthesia. | Drug: Sodium Fluoride with CPP-ACP<br> <br> * Other names: MI Varnish GC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU). | Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples using CRT Bacteria (Caries Risk Test, Ivoclar Vivadent) | 3 months |