Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Fluoride varnish + calcium (Clinpro White Varnish) and polipeptide solution (Curodont Repair) are effective in the treatment of remineralization therapy. The investigators will diagnose their alone or in combination effects on white spot lesions. Aesthetics (tooth-colored), remineralization, microbiological effects will be evaluated separately. Spectrophotometer (Vita Easy Shade) , Quantitative Light Fluorescence (QLF), Diagnodent(Cavo Diagnodent) and culture methods in microbiology laboratories are used for aesthetic, remineralization and microbiological assessments. The measurements will be made baseline, 6 weeks, 3 months and 6 months later after the applications and recorded.

Detailed Description
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The aim of this study is that evaluate the remineralizing and antibacterial effects of the different remineralization agents. Initiative caries lesions named as white spot lesions and these lesions are localized at enamel. Demineralization is occured but cavitations aren't seen at this stage. It is important to control at this stage with remineralization agents because of the minimally invasive approach. Fluoride varnish or polipeptide containing agents alone or combination using effects on remineralization, esthetic and bacterial counts will be evaluated with Quantitive Light Fluorescence , Diagnodent (Cavo-Diagnodent), Spectrophotometer (Vita Easy Shade) devices and microbiological assessment at laboratory. The investigators will choose and include in our study that who come to the Ege University Faculty of Dentistry pediatric department, between 10-18 years olds, healthy and have one or more white spot lesions on her/his permanent teeth. 32 volunteer who have inclusion criteria will be put into pratice. 32 volunteer divided into 4 groups for different applications. We will tell each volunteer that they must brush their teeth twice a day with fluoride dentifrice ( the investigators will give them 1400 ppm fluoride containing fluoride dentifrice) Group: Control group ( The investigators won't do any application , the oral hygiene konwledge will be given only.) Group: Fluoride + Calcium (TCP) (The investigators will do fluoride+ calcium varnish( Clinpro white varnish) application on white spot lesions) Group: Polipeptide solution (The investigators will do polipeptide ( Curodont repair) solution application on white spot lesions) Group: [Fluoride + calcium varnish] + polipeptide solution combination ( The investigators will do polipeptide ( Curodont repair) solution and fluoride + calcium varnish (Clinpro white varnish) application on white spot lesions) First day,the investigators will collect stimulated saliva from each volunteer before any application. Saliva samples will transport to the microbiology laboratory. After any application 6 weeks, 3 months and 6 months later we will collect stimulated saliva again for microbiological assessment. Nyvad Caries Diagnostic Criteria , ICDAS indexes will be used to make the follow-up of lesions at baseline and 6 months after the application. Plaque index (Silness & Löe , 1964) and bleeding index (Ainamo&Bay ,1976) will be used to assess oral hygiene every visit. The investigators will use QLF,Diagnodent devices will be used at beginning for evaluate the demineralization level and after applications 6 weeks, 3 months and 6 months later used for evaluate the remineralization level. In addition for determine about esthetic results the investigators will use spectrophotometer (Vita Easy Shade) device at beginning, 6 weeks, 3 months and 6 months later.

Official Title
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Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions

Conditions
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White Spot Lesions

Intervention / Treatment
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* Other: Clinpro White Varnish (fluoride + calcium varnish)
* Other: Curodont Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 10-18 years olds healthy have one or more white spot lesions on her/his permanent teeth Exclusion Criteria: have any health problem unsuitable age don't give approval for this study

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>The investigators won't do any application , the oral hygiene konwledge will be given only. | |
| Active Comparator: Fluoride + Calcium varnish<br>The investigators will do fluoride+ calcium varnish( Clinpro White Varnish) application on white spot lesions. | Other: Clinpro White Varnish (fluoride + calcium varnish)<br>* Clinpro White Varnish will be applied to the teeth with brush.<br>|
| Experimental: Polipeptide solution<br>The investigators will do polipeptide ( Curodont Repair) solution application on white spot lesions. | Other: Curodont Repair<br>* Curodont Repair solution be applied to the teeth in the form of drops<br>|
| Experimental: Fluoride + calcium + polipeptide<br>The investigators will do polipeptide ( Curodont Repair) solution and fluoride + calcium varnish (Clinpro White Varnish) application on white spot lesions. | Other: Clinpro White Varnish (fluoride + calcium varnish)<br>* Clinpro White Varnish will be applied to the teeth with brush.<br>Other: Curodont Repair<br>* Curodont Repair solution be applied to the teeth in the form of drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QLF ( ∆F, ∆Q, lesion area) | remineralization level assesment | Change baseline enamel fluorescence level at 6 weeks, 3 and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Streptococcus mutans and lactobacilli counts | Microbiological assesment | baseline, after 6 weeks, 3 months and 6 months of the application | 
| Spectrophotometer ( L, a, b) | esthetic assesment | baseline, after 6 weeks, 3 months and 6 months of the application | 
| Diagnodent | remineralization level assesment | baseline | 
| Nyvad Caries Diagnostic Criteria index and ICDAS index | Evaluation of the state of the lesion | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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White spot lesions, remineralization, QLF, antibacterial