Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial

Study Overview
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Brief Summary
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The goal of modern dentistry is to manage non-cavitated caries lesions non- invasively through re-mineralization process to prevent the disease progression and improve aesthetics, strength, and function. Re-mineralization is defined as the process that supplies calcium, phosphate and flouride ions from an external source to the tooth to convert ion deposition into crystal voids in demineralized enamel. White spot lesions should be managed using a multifactorial approach. The most important strategy is to prevent demineralization and biofilm formationand use of methodologies for remineralization of lesions . Self-assembling peptide (P11-4) has shown great potential for natural repair of early caries lesions through emerging biomimetic re-mineralization properties. (Takahashi Fet al in 2015) This peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration

Official Title
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Remineralization Potential of Curodont Repair Flouride Plus Versus CPP-ACP in Management of White Spot Lesions: Randomized Clinical Trial

Conditions
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White Spot Lesion

Intervention / Treatment
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* Drug: Self assembling peptide with fluoride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18 and 35 years of age female and males Had received conventional periodontal therapy Active carious white spot lesions No systemic diseases or concomitant medication affecting salivary flow Exclusion Criteria: - Participant in another trial Non carious lesion (enamel hypoplasia and dental flourosis) Presence of abnormal oral, medical, or mental condition. Participants who had evidence of reduced salivary flow or significant tooth wear. Allergy to MI paste

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Self assembling peptide with fluoride<br> | Drug: Self assembling peptide with fluoride<br>* peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration<br>* Other names: Curodont Repair Fluoride Plus;|
| Active Comparator: Casein-phosphopeptide/amorphous-calcium phosphate<br> | Drug: Self assembling peptide with fluoride<br>* peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration<br>* Other names: Curodont Repair Fluoride Plus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization potential | by: Inspection under magnification ICDAS II Score 0:Sound tooth surface: First visual change in enamel. Distinct visual change in enamel visible when wet, lesion must be visible when dry. | T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months Assessment of white spot lesion regres( | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remineralization potential | by: Image analysis software Change in area of the white spot lesion (mm2) | T0:baseline assessment -->T1:1 month (Assessment of white spot lesion regression)--> T2:4 months(Application of Curodont repair flouride plus /Cpp-Acp andAssessment of white spot lesion regression)--> T3: 6 months( Assessment of white spot lesion regres |