Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

Early Childhood Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625310
• Other study ID #: Kirikkale University
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Kirikkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 72 Months

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Drug:
• Sodium Fluoride

• Sodium Fluoride with TCP

• Sodium Fluoride with CXP

• Sodium Fluoride with CPP-ACP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merve Erkmen Almaz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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