Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

Study Overview
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Brief Summary
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The modern concept in caries treatment focuses on the non-invasive approach and on the biomimetic remineralization of early non-cavitated white spot carious lesions. Recently developed biomimetic scaffolds attempt to remineralize the dental tissues and are more regenerative than reparative.

Official Title
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Clinical and Topographic Evaluation of the Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions (a Randomized Controlled Clinical Trial and In-vitro Study)

Conditions
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White Spot Lesion

Intervention / Treatment
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* Other: Curodont repair Self- assembling peptide P11-4
* Other: Ph-chi phosphorylated - nano-chitosan
* Other: CCP-ACP  +ve control  Casein phosphopeptide amorphous calcium phosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who at least have 1 white spot lesion. No systemic diseases or taking any medication affecting salivary flow. Patients with good oral hygiene measures. Patients with moderate caries risk assessment. Post orthodontic WSLs with International Caries Detection and Assessment System (ICDAS II) scoring criteria (1-2). Exclusion Criteria: Participant in another trial. Developmental non carious lesion (enamel hypoplasia and dental fluorosis). Presence of abnormal oral disease, or medically compromised patients. Participants who had evidence of reduced salivary flow or significant tooth wear. Allergy to milk products or other drug allergies.

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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No

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: Group I<br> | Other: Curodont repair Self- assembling peptide P11-4<br>* The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by Curodont<br>|
| Experimental: Group II<br> | Other: Ph-chi phosphorylated - nano-chitosan<br>* The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by Ph-chi phosphorylated - nano-chitosan<br>|
| Active Comparator: Group III<br> | Other: CCP-ACP  +ve control  Casein phosphopeptide amorphous calcium phosphate<br>* The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by CCP-ACP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in DIAGNOdent values | The DIAGNOdent uses laser fluorescence to aid in the detection of caries within the tooth structure. | Baseline, 1 month, 3 months , 6 months, 9 months, 12 months | 
| change in ICDAS scores | Code Description 0: Sound tooth surface: No evidence of caries after 5 sec air drying First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying Distinct visual change in enamel visible when wet, lesion must be visible when dry Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying Underlying dark shadow from dentine Distinct cavity with visible dentine Extensive (more than half the surface) distinct cavity with visible dentine | Baseline, 1 month, 3 months , 6 months, 9 months, 12 months |