White Spot Lesion
Conditions
Keywords
curodont repair fluoride plus, CPP-ACPF, sodium fluoride varnish, guided enamel regeneration
Brief summary
the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.
Detailed description
The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.
Interventions
DRUGself assmbling peptide p11-4 combined with 0.05% fluoride
biomimetic remineralizing agent
remineralizing agents that acts as a fluoride booster
remineralizing agent that is used as a gold standard for remineralization
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
1. healthy children 2. age range 3-6 3. at least 2 early carious lesions
Exclusion criteria
1. Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases. 2. Application of fluoride varnish less than 3 months prior to study treatment. 3. Any metabolic disorders affecting bone turnover. 4. Concurrent participation in another clinical trial. 5. Patients receiving any antibiotic within 1 month prior to plaque sample collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing the remineralization of early carious lesions in primary teeth | 3,6,9 and12 months | comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| comparing the change in esthetic appearance of early carious lesion before and after treatment | 12 months | comparing the change in lesion size using standardized photographs quantitatively by calculating pixel size of the lesion before treatment and after 6 and 12 months of intensive mode of application of the different remineralizing agents using ImageJ software program for image analysis. Assessing the esthetic appearance of the lesions will be done subjectively by using a visual analogue scale score from 1 to 7 |
| comparing the antibacterial effect of different remineralizing agents against streptococcus mutans | 3 months | Supragingival plaque samples will be collected at baseline then after 48 hours, 1 months and 3 months of application of the materials in an intensive mode. log count of streptococcus mutans is determined using disk diffusion method using mitis salivaris agar plates |
Countries
Egypt
Outcome results
None listed