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

NCT03187548 — Phase 1, Unknown, 45 participants, Cairo University

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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

Registry	NCT03187548
Status	Unknown
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, prevention
Enrollment	45 (Estimated)
Sponsor	Cairo University (Other)
Conditions	White Spot Lesion, Enamel Hypomineralization
Interventions	Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste (Drug)
Dates	start 2017-07-01 (estimated), primary completion 2017-09-01 (estimated), completion 2018-01-01 (estimated), first posted 2017-06-15, last updated 2017-06-15

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
CPP-ACP	Experimental	Drug: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste	Casein phosphopeptide amorphous calcium phosphate dental paste

Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste (Drug): Application of CPP-ACP on one premolar once every 2 weeks for 3 months.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 15 Years to 30 Years, accepts healthy volunteers

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

+Investigators

Maha Swelam, Bachelor, Principal investigator, Department of orthodontics

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