Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents

Study Overview
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Brief Summary
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Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents

Detailed Description
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Medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (ACP), and Casin phosphopeptide amorphous calcium phosphate (CPP-ACP) has proved to be effective in reversing such lesions. Fluoride was considered the gold standard remineralizing agent , However several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion. Calcium-silicate based material such as β-CaSiO3 and β-Ca2SiO4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-CaSiO3 and β-Ca2SiO4 come in contact with saliva it will be dissolve forming silanol group (Si-O ) on the enamel surface which can bind to Ca ions and inducing the precipitation of hydroxyapatite. In the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.

Official Title
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Medical Treatment of Early-Enamel Carious Lesion Using Different Remeneralizing Agents: 2-years Randomized Clinical Trial

Conditions
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Enamel Caries

Intervention / Treatment
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* Drug: Silver diamine fluoride- potassium iodide
* Drug: Casein phosphopeptide amorphous calcium phosphate
* Drug: experimental tricalcium silicate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with early enamel lesions (ICDAS score 1 and 2). Patients with normal occlusion . Patients must have a good oral hygiene patients free from any systemic diseases and don't receive any medication Exclusion Criteria: smoker patients pregnant females patients with bad oral hygiene patients with enamel defects ( Amelogenesis Imperfecta, fluorosis, cracks or any developmental defects)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver diamine fluoride-potassium iodide SDF-KI (riva star)<br>SDF-KI was applied once as a professional application over the early enamel lesions in cervical third of the buccal surface of molar teeth. | Drug: Silver diamine fluoride- potassium iodide<br>* SDF-KI (riva star, SDI.Ltd )was applied ( as a professional application) by micro brush over the early enamel lesions on the buccal surface of molar teeth<br>|
| Experimental: casein phosphopeptide amorphous calcium phosphate CPP-ACP(tooth mousse)<br>CPP-ACP cream was applied twice daily according to manufacturer's instructions over the early enamel lesions in cervical third of the buccal surface of molar teeth. | Drug: Casein phosphopeptide amorphous calcium phosphate<br>* CPP-ACP (tooth mousse, GC, Matraville Sydney, Australia) was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing<br>|
| Experimental: Experimental tricalcium silicate<br>Experimental tricalcium silicate paste was applied twice daily over the early enamel lesions in cervical third of the buccal surface of molar teeth | Drug: experimental tricalcium silicate<br>* prepared tricalcium silicate paste was applied by using micro brush over the early enamel lesions on the buccal surface of the molar teeth twice daily. the patients were instructed to leave it for about 3minutes before rinsing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Treatment of Early-Enamel Carious Lesion using Different Remeneralizing agents | The primary outcome was the change in laser fluorescence values that was detected by DIAGNODent Pen. The obtained values were interpreted according to the scale provided by the manufacture: Value between (0-13) refers to sound enamel substrate Value between (14-20) refers to early enamel caries | 2-years after the first application of the remineralizing agents | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enamel remineralization, Randomized Clinical Trial, Experimental Tricalcium silicate, Sillver diamine flouride-potassium iodide