Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.

Official Title
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Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial

Conditions
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Remineralization

Intervention / Treatment
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* Drug: Monomeric self - assembling peptide P11-4
* Drug: Tricalcium phosphate fluoride varnish, 5% F-
* Drug: fluoride varnish (5% sodium fluoride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Apparently healthy cooperative children Aging from 3-5 years old child Both genders Primary teeth with active WSLs on buccal or labial surfaces Patient and parent acceptance to treatment and maintenance of good oral hygiene Exclusion Criteria: Restored teeth White spot lesions due to fluorosis Teeth with hypoplasia Lesions that require an invasive treatment Any pathology or concomitant medication affecting salivary flow or causing dry mouth

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curodont Repair® ( monomeric self - assembling peptide P11-4 )<br>Self assembling peptide P11-4 as Curodont Repair® can remineralize WSLs in a deeper manner than fluoride by guided enamel regeneration by forming a three-dimensional matrix within the subsurface body of an initial carious lesion to which calcium and phosphate ions found in natural saliva can bind and build de novo hydroxyapatite crystals. | Drug: Monomeric self - assembling peptide P11-4<br>* Monomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied on tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness.<br>* Other names: Curodont Repair;|
| Experimental: Clinpro white varnish® ( Tricalcium Phosphate Fluoride Varnish, 5% F- )<br>Tri-calcium phosphate can be hydrolyzed rapidly to form calcium hydroxyapatite (HAp). The processes of hydrolysis and formation of HAp are accelerated by the presence of NaF ions as in case of Clinpro white varnish®. Moreover, the HAp formed by such hydrolysis tends to have a greater uptake of fluoride than conventional HAp. | Drug: Tricalcium phosphate fluoride varnish, 5% F-<br>* Tricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide.<br>* Other names: 3M Clinpro white varnish;|
| Active Comparator: Voco-profluorid® fluoride varnish (5% sodium fluoride)<br>Fluoride varnish is the gold standard for treating WSLs. | Drug: fluoride varnish (5% sodium fluoride)<br>* fluoride varnish (5% sodium fluoride) ( Voco-profluorid ) is a remineralizing agent applied on tooth surface then area is allowed to become wet (either by gentle rinsing or natural salivary flow) to ensure setting of VOCO Profluorid Varnish.<br>* Other names: Voco-profluorid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of WSL ( white spot lesion ) | Size of WSL measured by scored dental probe | through study completion, an average of 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Regression of caries | Regression of caries evaluated by International Caries Detection and Assessment System (ICDAS) II | through study completion, an average of 8 months | 
| Inactivation of active carious lesions | Inactivation of active carious lesions evaluated by Lesion activity assessment (LAA-ICDAS) | through study completion, an average of 8 months | 
| Mineral content of WSL | Mineral content of WSL measured by fluorescence camera VistaCam iX | through study completion, an average of 8 months |