drugset / Trial / NCT03625310

Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

NCT03625310

Completed 88 enrolled Merve Erkmen Almaz
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2016-11
Primary completion
2017-07
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoride varnish Other / unclassified 5 % Topical
Subject Sodium Fluoride with CXP Unknown 5 % Topical
Subject Sodium Fluoride with TCP Unknown 5 % Topical
Comparator sodium fluoride Unknown 5 % Topical

Indications