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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indira Gandhi Institute of Dental Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 24, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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