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Effectiveness Fluoride Varnishes in Children With Early Childhood Caries

Sponsor
Merve Erkmen Almaz (Other)
Overall Status
Completed
CT.gov ID
NCT03625310
Collaborator
(none)
88
Enrollment
4
Arms
13
Actual Duration (Months)

Study Details

Study Description

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
  • Drug: Sodium Fluoride
  • Drug: Sodium Fluoride with TCP
  • Drug: Sodium Fluoride with CXP
  • Drug: Sodium Fluoride with CPP-ACP
 N/A

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

Study Type:
Interventional
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 :
Nov 1, 2016
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • MI Varnish GC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of fluoride varnishes on saliva Mutans streptococci (MS) and Lactobacilli (LB) levels were evaluated as colony forming units (CFU). [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

    Criteria

    Ages Eligible for Study:
    36 Months to 72 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merve Erkmen Almaz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merve Erkmen Almaz, assist prof, Kırıkkale University
    ClinicalTrials.gov Identifier:
    NCT03625310
    Other Study ID Numbers:
    • Kirikkale University
    First Posted:
    Aug 10, 2018
    Last Update Posted:
    Aug 10, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Listerine
    Fluorides
    Sodium Fluoride

    Study Results

    No Results Posted as of Aug 10, 2018