Clinical trial NCT03360266: Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Early Childhood Caries
Keywords: remineralization
fluoride varnish
Lead sponsor: Indira Gandhi Institute of Dental Science
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study model involves three groups
Primary purpose: PREVENTION

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)

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.

Eligibility 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.

Primary outcomes:
measure: Dimension and Activity of white spot lesions.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IGIDS
name: Kayalvizhi Gurusamy, MDS
role: STUDY_DIRECTOR
References:
citation: 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.