Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

NCT ID: NCT03625310

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Early Childhood Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Sodium Fluoride

Varnish containing 5% Sodium Fluoride, was applied to all remaining teeth of each child after dental treatment under general anaesthesia.

Group Type: ACTIVE_COMPARATOR

Sodium Fluoride

Intervention Type: DRUG

Sodium Fluoride with TCP

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.

Group Type: EXPERIMENTAL

Sodium Fluoride with TCP

Intervention Type: DRUG

Sodium Fluoride with CXP

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.

Group Type: EXPERIMENTAL

Sodium Fluoride with CXP

Intervention Type: DRUG

Sodium Fluoride with CPP-ACP

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.

Group Type: EXPERIMENTAL

Sodium Fluoride with CPP-ACP

Intervention Type: DRUG

Interventions

Sodium Fluoride

Intervention Type: DRUG

Sodium Fluoride with TCP

Intervention Type: DRUG

Sodium Fluoride with CXP

Intervention Type: DRUG

Sodium Fluoride with CPP-ACP

Intervention Type: DRUG

Other Intervention Names

Colgate Duraphat varnish; Clinpro ™ White Varnish 3M ESPE; Embrace ™ Varnish Pulpdent; MI Varnish GC

Eligibility Criteria

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

• Minimum Eligible Age: 36 Months
• Maximum Eligible Age: 72 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merve Erkmen Almaz

OTHER

Sponsor Role: lead

Responsible Party

Merve Erkmen Almaz

assist prof

Responsibility Role: SPONSOR_INVESTIGATOR

References

Erkmen Almaz M, Akbay Oba A. Antibacterial activity of fluoride varnishes containing different agents in children with severe early childhood caries: a randomised controlled trial. Clin Oral Investig. 2020 Jun;24(6):2129-2136. doi: 10.1007/s00784-020-03300-w. Epub 2020 Apr 30.

Reference Type: DERIVED

PMID: 32356211 (View on PubMed)

Other Identifiers

Kirikkale University

Identifier Type: -

Identifier Source: org_study_id