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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

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE December 4, 2017
Last Update Posted Date December 4, 2017
Actual Study Start Date  ICMJE March 21, 2016
Actual Primary Completion Date December 24, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Remineralizing Efficacy of Combination Varnishes on White Spot Lesions in ECC Children
Official Title  ICMJE Comparative Evaluation of Remineralizing Efficacy of Fluoride Varnish and Its Combination Varnishes on White Spot Lesions in Children With ECC: A Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Child
  • Early Childhood Caries
Intervention  ICMJE
  • 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
  • Drug: 5% Sodium Fluoride Varnish
    ffor children with ECC, this varnish effectively remineralizes the white spot lesion
    Other Name: Profluorid
Study Arms  ICMJE
  • Active Comparator: Profluorid group
    5% Sodium Fluoride varnish (Profluorid varnish) applied over white spot lesions on maxillary anterior teeth
    Interventions:
    • Combination Product: Sodium Fluoride with CPP-ACP varnish
    • Combination Product: sodium fluoride with ACP varnish
  • Experimental: Enamel Pro
    Sodium Fluoride with ACP varnish (Enamel Pro varnish) applied over white spot lesions on maxillary anterior teeth
    Interventions:
    • Combination Product: Sodium Fluoride with CPP-ACP varnish
    • Drug: 5% Sodium Fluoride Varnish
  • Experimental: MI varnish
    Sodium Fluoride with CPP-ACP varnish (MI varnish) applied over white spot lesions on maxillary anterior teeth
    Interventions:
    • Combination Product: sodium fluoride with ACP varnish
    • Drug: 5% Sodium Fluoride Varnish
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2017)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 17, 2017
Actual Primary Completion Date December 24, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03360266
Other Study ID Numbers  ICMJE IIGIDSIIRB2015 NDP20PGRSPPD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party DR.S.RADHA, Indira Gandhi Institute of Dental Science
Study Sponsor  ICMJE Indira Gandhi Institute of Dental Science
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kayalvizhi Gurusamy, MDS IGIDS
PRS Account Indira Gandhi Institute of Dental Science
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP