MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.

Study Overview
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Brief Summary
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Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.

Detailed Description
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The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).

Official Title
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The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial

Conditions
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Prevention

Intervention / Treatment
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* Drug: MI Varnish
* Drug: PreviDent Varnish
* Drug: 1.23% APF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 7-10 mixed dentition Patients with any incipient non cavitated posterior proximal caries Patients with any incipient non cavitated anterior proximal cariesanterior ICDAS Score 1 or 2 Exclusion Criteria: Any patients with any serious chronic medical problem. caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity history of proximal restorations history of resin infiltrate ICDAS score of proximal caries more than two clinically or radiographically.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI Varnish Group<br>The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Remineralization protocol, group one will be treated with MI varnish according to the manufacture instructions in first visit and each follow up visits. | Drug: MI Varnish<br>* Application of MI varnish material versus the standard 1.23% APF.<br>* Other names: GC MI varnish, Recaldent, primary DI number: D6580052651;|
| Experimental: PreviDent Varnish Group<br>The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Group two will receive PreviDent varnish according to the manufacture instructions in the first visit and each follow up visits. | Drug: PreviDent Varnish<br>* Application of PreviDent Varnish material versus the standard 1.23% APF.<br>* Other names: Colgate PreviDent varnish ,product DI number: 00038341330937;|
| Active Comparator: 1.23% APF Control Group<br>Regular application of APF for 4 minutes with high volume suction to the whole mouth. | Drug: 1.23% APF<br>* Standard 1.23% APF application<br>* Other names: ZAP fluoride gel, NDC Number: 24794-0102-16;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic outcome | Incipient lesions either remained the same or worsened. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical examination | Lesion cavitation | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, interproximal caries, MI varnish, PreviDent varnish, Fluoride, 1.23% APF Fluoride