Evaluation of CPP-ACP Prophylactic Effect on Enamel Surface During Orthodontic Treatment

Study Overview
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Brief Summary
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This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.

Detailed Description
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CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.

Official Title
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Evaluation of the Demineralizing Effect on Enamel Surface During Orthodontic Treatment With and Without the Addition of Casein Phosphopeptides-Amorphous Calcium Phosphate (CPP-ACP) on: A Randomized Clinical Trial, Split Mouth Design

Conditions
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White Spot Lesion, Enamel Hypomineralization

Intervention / Treatment
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* Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe crowding Increased overjet Protruded maxillary base Sound maxillary premolars medically free molar classification class II Canine classification class II Exclusion Criteria: spacing of teeth Decreased overjet Molar classification III Medically compromised patients pregnant females carious premolars hypoplasia

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPP-ACP<br>Casein phosphopeptide amorphous calcium phosphate dental paste | Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste<br>* Application of CPP-ACP on one premolar once every 2 weeks for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on enamel surface color | Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II | 3 months | 
| Effect on enamel surface | Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph | 3 mnths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface texture | Assessment of the effect of CPP-ACP on enamel surface texture using scanning electron microscope | 3 months | 
| Microhardnes | Assessment of the effect of CPP-ACP on enamel microhardness using Vickers hardness test | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WSL, CPP-ACP