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Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03625310
Enrollment
88
Registered
2018-08-10
Start date
2016-11-30
Completion date
2017-12-31
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Caries

Brief summary

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; 1. Duraphat varnish containing 5% Sodium Fluoride (Colgate) (n = 22), 2. Clinpro ™ White Varnish containing 5% of Sodium Fluoride tricalcium phosphate (3M ESPE) (n = 22), 3. Embrace ™ Varnish containing 5% Sodium Fluoride with CXP ™ (Pulpdent) (n = 22), 4. 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

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.

Interventions

DRUGSodium Fluoride with TCP
DRUGSodium Fluoride with CXP

Sponsors

Merve Erkmen Almaz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
36 Months to 72 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU).3 monthsSaliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples using CRT Bacteria (Caries Risk Test, Ivoclar Vivadent)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026