Remineralization effect of bioactive glass fluoride varnish on white spot lesions in primary teeth of children with early childhood caries in comparison with conventional fluoride varnish a randomized controlled study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- The primary objective of this study will be to evaluate the extent of remineralization on the non-cavitated enamel white spot lesions on the primary teeth of children with ECC at 6 month and 1 year follow-up by bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish applied with an intensive application regimen (3 applications in two weeks), using laser fluorescence (DIAGNOdent).
Study Overview
Brief Summary
The aim of this study is to evaluate the remineralizing effect of sodium fluoride containing dental varnish fortified with bioactive glass on the white spot lesions in primary teeth of children with early childhood caries (ECC).
The time period of this study is 24 months including 12-month follow-up.
The study will be conducted in the Department of Pediatric and Preventive Dentistry, Manipal College of Dental Sciences Mangalore.
Children will be screened according to the inclusion criteria and will be divided into two groups-
Group 1- Sodium fluoride varnish (Fluoritop SR Varnish)
Group 2- Sodium Fluoride containing dental varnish fortified with bioglass (FluoroDip Bioactive)
The dmft, plaque index and a questionnaire on oral health practices to gather baseline data will be recorded. The teeth will be dried and DIADNOdent readings will be taken for teeth with White Spot Lesions. All patients will undergo oral prophylaxis with ultrasonic scaler and polishing using non-fluoridated prophylaxis paste in first visit.
For both groups, 0.5ml of varnish will be applied on dried teeth using an applicator brush and air dried for 15-20 seconds to ensure setting. The teeth with WSL will receive two more applications of fluoride varnish within a 2-week period using the same procedure described above for their corresponding fluoride varnishes, thus amounting to 3 applications in 2 weeks for the white spot lesions.
dmft index, ICDAS-LAA score and DIAGNOdent readings will be recorded at 6-month and 12-month follow-ups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 2.00 Year(s) to 6.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Children with non-cavitated white spot lesions on the buccal and lingual surfaces of primary teeth with ICDAS score 1 (first visual change in enamel after air drying) and ICDAS score 2 (distinct visual change in enamel even when wet).
- •Children exhibiting Frankl’s definitely positive, positive and negative behaviour.
Exclusion Criteria
- •Children exhibiting Frankl’s definitely negative behaviour.
- •Children with systemic and mental illness.
- •Tooth with cavitated lesions.
- •Tooth nearing exfoliation time.
- •Tooth with developmental defects.
- •History of allergy to colophony base (resin).
Outcomes
Primary Outcomes
The primary objective of this study will be to evaluate the extent of remineralization on the non-cavitated enamel white spot lesions on the primary teeth of children with ECC at 6 month and 1 year follow-up by bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish applied with an intensive application regimen (3 applications in two weeks), using laser fluorescence (DIAGNOdent).
Time Frame: 6 month and 12 month follow up
Secondary Outcomes
- To assess the lesion activity status of the white spot lesions on the primary tooth surfaces of children with ECC using ICDAS-LAA classification at 6 month and 1 year follow-up after application of bioactive glass fortified sodium fluoride varnish in comparison with conventional sodium fluoride varnish.
Investigators
Avnee Kalia
Manipal College of Dental Sciences Mangalore