Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children

November 27, 2017 updated by: DR.S.RADHA, Indira Gandhi Institute of Dental Science

Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early childhood caries (ECC) is the presence of 1 or more decayed (Non - Cavitated or Cavitated lesions), missing (due to caries) or filled tooth surface in any primary tooth in a child of 71 months of age or younger. In children younger than 3 years of age, any sign of smooth-surface caries is indicative of severe early childhood caries (S-ECC). It is a virulent form of caries, which develops on smooth surfaces and progresses rapidly. In children aged 12 to 30 months it initially affects the maxillary primary incisors and first primary molars, reflecting the pattern of eruption.

In ECC, the first clinical observation of demineralization in enamel is the white spot lesion, which is characterized by enamel demineralization of the subsurface, with increasing porosity due to the removal of minerals into the outer surface. At this stage, the caries lesion is usually reversible.

In young children, remineralization can be achieved by Non- invasive methods that are very effective. Fluoride prevents the caries process, leading to the formation of less soluble fluorapatite crystals. Among them, Topical fluorides are the most respected regimen. On application of topical fluorides to the teeth, calcium fluoride-like globules are formed on the tooth surface. These globules are effective mineral reservoirs that help prevent demineralization and promote remineralization by releasing calcium, phosphate and fluoride following acid attacks.

American Academy of Pediatric Dentistry (AAPD) recommends fluoride varnish in children. Randomized control trials have found it to be efficacious in primary teeth. Fluoride varnish can reverse or arrest caries lesions as well as prevent demineralization process of an incipient caries/white spot lesion, when combined with other preventive measures such as oral hygiene instructions & diet counseling.Children at increased caries risk should receive a professional fluoride treatment at least every six months. There is evidence from randomized controlled trials and meta-analyses that professionally applied topical fluoride treatments as five percent sodium fluoride varnish or 1.23 percent fluoride gel preparations are efficacious in reducing caries in children at caries risk.

Fluoride varnish works by increasing the concentration of fluoride in the outer surface of teeth, thereby enhancing fluoride uptake during early stages of demineralization. The varnish hardens on the tooth as soon as it contacts saliva, allowing the high concentration of fluoride to be in contact with tooth enamel for an extended period of time This is a much longer exposure compared to other high-dose topical fluorides such as gels or foams, with less risk of fluorosis even in children younger than 6 years.

It has been observed from the literature review that only invitro studies and few clinical studies have been done in treating WSL in orthodontic patients using these combination varnishes. To our Knowledge, no clinical studies has assessed its efficacy and compared the effectiveness of these combination varnishes in remineralising white spot lesions of ECC in young children. Thus, this study was planned to compare the remineralizing efficiency of fluoride varnish with a combination of fluoride and calcium phosphate varnishes on white spot lesions in smooth surfaces of primary anterior teeth of children with ECC.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Profluorid group
5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth
Combination product: Sodium Fluoride with CPP-ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
Other Names:
  • MI varnish
Combination product: sodium fluoride with ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
Other Names:
  • Enamel Pro
Experimental: Enamel Pro
Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth
Combination product: Sodium Fluoride with CPP-ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
Other Names:
  • MI varnish
Drug: 5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Other Names:
  • Profluorid
Experimental: MI varnish
Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth
Combination product: sodium fluoride with ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
Other Names:
  • Enamel Pro
Drug: 5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Other Names:
  • Profluorid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimension and Activity of white spot lesions.
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indira Gandhi Institute of Dental Science

Investigators

  • Study Director: Kayalvizhi Gurusamy, MDS, IGIDS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2016

Primary Completion (Actual)

December 24, 2016

Study Completion (Actual)

March 17, 2017

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIGIDSIIRB2015 NDP20PGRSPPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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