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Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

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ClinicalTrials.gov Identifier: NCT03625310
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Merve Erkmen Almaz, Kırıkkale University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Early Childhood Caries Drug: Sodium Fluoride Drug: Sodium Fluoride with TCP Drug: Sodium Fluoride with CXP Drug: Sodium Fluoride with CPP-ACP Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Sodium Fluoride
Varnish containing 5% Sodium Fluoride, was applied to all remaining teeth of each child after dental treatment under general anaesthesia.
 Drug: Sodium Fluoride
Other Name: Colgate Duraphat varnish
Experimental: 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.
 Drug: Sodium Fluoride with TCP
Other Name: Clinpro ™ White Varnish 3M ESPE
Experimental: 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.
 Drug: Sodium Fluoride with CXP
Other Name: Embrace ™ Varnish Pulpdent
Experimental: 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.
 Drug: Sodium Fluoride with CPP-ACP
Other Name: MI Varnish GC


Outcome Measures
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Primary Outcome Measures :
  1. Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU). [ Time Frame: 3 months ]
    Saliva Mutans streptococci (MS) and Lactobacilli (LB) levels, were evaluated by taking saliva samples using CRT Bacteria (Caries Risk Test, Ivoclar Vivadent)


Eligibility Criteria
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Ages Eligible for Study:   36 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merve Erkmen Almaz, assist prof, Kırıkkale University
ClinicalTrials.gov Identifier: NCT03625310    
Other Study ID Numbers: Kirikkale University
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Cariostatic Agents
 Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents