Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children
Condition: Child; Early Childhood Caries
Study type: Interventional

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)
    

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.
    

Intervention name(s): Sodium Fluoride with CPP-ACP varnish; sodium fluoride with ACP varnish; 5% Sodium Fluoride Varnish
Intervention type(s): Combination Product; Combination Product; Drug
Intervention description(s): for children with ECC, this varnish effectively remineralizes the white spot lesion; for children with ECC, this varnish effectively remineralizes the white spot lesion; ffor children with ECC, this varnish effectively remineralizes the white spot lesion
Other intervention name(s): MI varnish; Enamel Pro; Profluorid
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study model involves three groups
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: remineralization; fluoride varnish