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Trial record 74 of 292 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT03360266
Recruitment Status : Completed
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
DR.S.RADHA, Indira Gandhi Institute of Dental Science

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)

Condition or disease Intervention/treatment Phase
Child Early Childhood Caries Combination Product: Sodium Fluoride with CPP-ACP varnish Combination Product: sodium fluoride with ACP varnish Drug: 5% Sodium Fluoride Varnish Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study model involves three groups
Masking: Single (Investigator)
Masking Description: Investigator is masked in application of fluoride varnish and during all followup visits
Primary Purpose: Prevention
Official Title: Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial
Actual Study Start Date : March 21, 2016
Actual Primary Completion Date : December 24, 2016
Actual Study Completion Date : March 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

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 Name: MI varnish

Combination Product: sodium fluoride with ACP varnish
for children with ECC, this varnish effectively remineralizes the white spot lesion
Other Name: 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 Name: MI varnish

Drug: 5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Other Name: 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 Name: Enamel Pro

Drug: 5% Sodium Fluoride Varnish
ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Other Name: Profluorid




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360266


Sponsors and Collaborators
Indira Gandhi Institute of Dental Science
Investigators
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Study Director: Kayalvizhi Gurusamy, MDS IGIDS

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Responsible Party: DR.S.RADHA, Principal investigator, Indira Gandhi Institute of Dental Science
ClinicalTrials.gov Identifier: NCT03360266     History of Changes
Other Study ID Numbers: IIGIDSIIRB2015 NDP20PGRSPPD
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by DR.S.RADHA, Indira Gandhi Institute of Dental Science:
remineralization
fluoride varnish
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Fluorides, Topical
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents