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

Phase 1

• Conditions: White Spot Lesion; Enamel Hypomineralization
• Interventions: Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste

• Registration Number: NCT03187548
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15
• Study Start: 2017-07
• Primary Completion: 2017-09
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• severe crowding
• Increased overjet
• Protruded maxillary base
• Sound maxillary premolars
• medically free
• molar classification class II
• Canine classification class II

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Exclusion Criteria

• spacing of teeth
• Decreased overjet
• Molar classification III Medically compromised patients
• pregnant females
• carious premolars
• hypoplasia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPP-ACP	Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste	Casein phosphopeptide amorphous calcium phosphate dental paste

Primary Outcome Measures

Name	Time	Method
Effect on enamel surface color	3 months	Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II
Effect on enamel surface	3 mnths	Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph

Secondary Outcome Measures

Name	Time	Method
Surface texture	3 months	Assessment of the effect of CPP-ACP on enamel surface texture using scanning electron microscope
Microhardnes	3 months	Assessment of the effect of CPP-ACP on enamel microhardness using Vickers hardness test