NCT03360266

Brief Summary

The remineralizing efficacy of 3 fluoride varnishes were assessed in children with white spot lesion under 6 years of age ( children with early childhood caries)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

October 30, 2017

Last Update Submit

November 27, 2017

Conditions

ChildEarly Childhood Caries

Keywords

remineralizationfluoride varnish

Outcome Measures

Primary Outcomes (1)

  • Dimension and Activity of white spot lesions.

    The dimension of white spot lesions were measured with photographs using Adobe photoshop software. After prolonged air drying of 5 sec, the activity of white spot lesions were visualized using CPITN probe

    6 months

Study Arms (3)

Profluorid group

ACTIVE COMPARATOR

5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth

Combination Product: Sodium Fluoride with CPP-ACP varnishCombination Product: sodium fluoride with ACP varnish

Enamel Pro

EXPERIMENTAL

Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth

Combination Product: Sodium Fluoride with CPP-ACP varnishDrug: 5% Sodium Fluoride Varnish

MI varnish

EXPERIMENTAL

Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth

Combination Product: sodium fluoride with ACP varnishDrug: 5% Sodium Fluoride Varnish

Interventions

Sodium Fluoride with CPP-ACP varnishCOMBINATION_PRODUCT

for children with ECC, this varnish effectively remineralizes the white spot lesion

Also known as: MI varnish
Enamel ProProfluorid group
sodium fluoride with ACP varnishCOMBINATION_PRODUCT

for children with ECC, this varnish effectively remineralizes the white spot lesion

Also known as: Enamel Pro
MI varnishProfluorid group
5% Sodium Fluoride VarnishDRUG

ffor children with ECC, this varnish effectively remineralizes the white spot lesion

Also known as: Profluorid
Enamel ProMI varnish

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preschool children with ECC.
  • Children with active white spot lesions on labial surface of 1 or more primary maxillary anterior teeth.
  • Children whose parents signed the informed consent form/willing to participate in the study.
  • Apart from fluoride varnish and fluoridated tooth paste, subjects exposed to no other form of fluoride were included.

You may not qualify if:

  • Preschool children with cavitated lesions on primary maxillary anterior teeth.
  • Developmental enamel alterations (hypoplasia, fluorosis).
  • Children with systemic diseases.
  • Children with allergy to milk products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Radha S, Kayalvizhi G, Adimoulame S, Prathima GS, Muthusamy K, Ezhumalai G, Jagadesaan N. Comparative Evaluation of the Remineralizing Efficacy of Fluoride Varnish and its Combination Varnishes on White Spot Lesions in Children with ECC: A Randomized Clinical Trial. Int J Clin Pediatr Dent. 2020 Jul-Aug;13(4):311-317. doi: 10.5005/jp-journals-10005-1673.

    PMID: 33149400DERIVED

MeSH Terms

Interventions

Sodium FluorideEnamel Pro Varnish

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Kayalvizhi Gurusamy, MDS

    IGIDS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator is masked in application of fluoride varnish and during all followup visits
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study model involves three groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 30, 2017

First Posted

December 4, 2017

Study Start

March 21, 2016

Primary Completion

December 24, 2016

Study Completion

March 17, 2017

Last Updated

December 4, 2017

Record last verified: 2017-11