Child Clinical Trial
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
Verified date | November 2017 |
Source | Indira Gandhi Institute of Dental Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 60 |
Est. completion date | March 17, 2017 |
Est. primary completion date | December 24, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Indira Gandhi Institute of Dental Science |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dimension and Activity of white spot lesions. | 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 |
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