MedTrace Logo

Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

NCT03625310 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-08-10

No results posted yet for this study

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.

Conditions

  • Early Childhood Caries

Interventions

DRUG

Sodium Fluoride

DRUG

Sodium Fluoride with TCP

DRUG

Sodium Fluoride with CXP

DRUG

Sodium Fluoride with CPP-ACP

Sponsors & Collaborators

  • Merve Erkmen Almaz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
36 Months
Max Age
72 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-07-31
Completion
2017-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03625310 on ClinicalTrials.gov