Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

NCT03625310 | Completed

• 1 other identifier: Kirikkale University
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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

Conditions

Early Childhood Caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Sodium Fluoride

ACTIVE COMPARATOR

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

Drug: Sodium Fluoride

Sodium Fluoride with TCP

EXPERIMENTAL

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.

Drug: Sodium Fluoride with TCP

Sodium Fluoride with CXP

EXPERIMENTAL

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.

Drug: Sodium Fluoride with CXP

Sodium Fluoride with CPP-ACP

EXPERIMENTAL

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.

Drug: Sodium Fluoride with CPP-ACP

Interventions

Sodium Fluoride DRUG

Also known as: Colgate Duraphat varnish

Sodium Fluoride

Sodium Fluoride with TCP DRUG

Also known as: Clinpro ™ White Varnish 3M ESPE

Sodium Fluoride with TCP

Sodium Fluoride with CXP DRUG

Also known as: Embrace ™ Varnish Pulpdent

Sodium Fluoride with CXP

Sodium Fluoride with CPP-ACP DRUG

Also known as: MI Varnish GC

Sodium Fluoride with CPP-ACP

Eligibility Criteria

• Age: 36 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• clinical diagnosis of healthy children with severe early childhood caries,
• younger than 6 years in the primary dentition

You may not qualify if:

• 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

Sponsors & Collaborators

• Merve Erkmen Almaz: lead

Related Publications (1)

• 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.

  PMID: 32356211 DERIVED

MeSH Terms

Interventions

Sodium Fluoride; tenocyclidine; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assist prof

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 10, 2018
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08