Remineralization Efficacy of Gum Arabic Varnish.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.

Official Title
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Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.

Conditions
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Caries,Dental, Remineralization, White Spot Lesion

Intervention / Treatment
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* Drug: Gum Arabic varnish
* Drug: Proflourid Varnish,VOCO
* Drug: MI Varnish,GC Japan Inc.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with initial carious lesions. Proper Oral hygiene. Exclusion Criteria: Patients with a compromised medical history. Patients with active severe periodontal disease. Patients with hypoplastic or hypomineralized teeth.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 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: Gum Arabic varnish<br>Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization. | Drug: Gum Arabic varnish<br>* Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).<br>* Other names: Acacia senegal;|
| Active Comparator: Sodium Fluoride varnish<br>The gold standard remineralizing agent recommended by the guidelines. | Drug: Proflourid Varnish,VOCO<br>* 5% NaF varnish<br>|
| Active Comparator: 10% w/v CPP-ACP, 5% sodium fluoride varnish<br>CPP-ACP is the most studied non fluoride remineralizing agent. | Drug: MI Varnish,GC Japan Inc.<br>* CPP-ACP with fluoride based varnish<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization through determination of lesion progression or regression | Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion. | Change from baseline at 3,6, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries lesion activity assessment | Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer) | Change from baseline at 3,6, 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Initial carious lesion, Gum Arabic, Remineralization power, fluoride varnish, Mi varnish, Acacia senegal