Remineralization Potential of MI Varnish Versus Fluoride Varnish on White Spot Lesions in Maxillary Primary Incisors

Study Overview
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Brief Summary
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Remineralization effect of CPP-ACP and Fluoride (MI varnish) versus Fluoride varnish on white spot lesions in maxillary primary incisors

Detailed Description
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Early childhood caries (ECC) is a very common and consequential chronic disease affecting young children ( Çolak et al., 2013). The prevalence of ECC in Egypt is high, it is about (78%) according to the last Egyptian Report, 2014. ECC begins with white-spot lesions, and caries can progress continuously, leading to complete destruction of the crown. Calcium and phosphate ions are more readily lost for children because lower mineralization of deciduous enamel. The disease usually develops very quickly and causes many childhood health problems, such as caries-related toothache and infection. Demineralization and remineralization are dynamic processes in caries initiation, progression, and reversal. Therefore, regulation of the demineralization- remineralization balance is a key to caries prevention and treatment. The ideal method of increasing remineralization is reconstructing the depleted tissues with hydroxyapatite, which is the same inorganic component as the enamel. Fluoride varnishes have been the standard practice for the professional application of fluoride. Casien PhosphoPeptide (CPP) is a sticky protein that binds and stabilizes calcium and phosphate ions in an amorphous state. CPP-ACP has been shown to adhere to teeth surfaces.

Official Title
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Remineralization Potential of MI Varnish(CPP-ACP and Fluoride) Versus Fluoride Varnish in Controlling White Spot Lesions in Maxillary Primary Incisors: A Randomized Clinical Trial

Conditions
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Remineralization Effect of the Varnish on White Spot Lesions

Intervention / Treatment
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* Other: MI varnish


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with white spot lesions on their incisors. Age ranging 3-5 years. Good general health. Exclusion Criteria: 1. Chronic use of medications or antibiotics 2. lack of cooperation in the oral examination 3. Allergies to milk protein or benzoate preservatives 4. Presence of oral soft-tissue lesions or enamel hypoplasia at baseline examination, 5. Children who have received a fluoride supplement or professional topical fluoride application at least 3 months before or during the study period. -

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI Varnish<br> | Other: MI varnish<br>* CPP- ACP with 5 % sodium fluoride GC<br>* Other names: CPP- ACP with fluoride;|
| Active Comparator: Profluorid Varnish<br> | Other: MI varnish<br>* CPP- ACP with 5 % sodium fluoride GC<br>* Other names: CPP- ACP with fluoride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries activity | Measured by ICDAS II | Change from base line, after application at 3, 6, 9 last follow up 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization | Measured by EDI | Change from base line, after application at 3, 6, 9 last follow up 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early childhood caries, Casein phosphopeptides-amorphous calcium phosphate, fluoride, remineralization potential, varnish