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

NCT ID: NCT03187548

Last Updated: 2017-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-01-31

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.

Conditions

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White Spot Lesion Enamel Hypomineralization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CPP-ACP

Casein phosphopeptide amorphous calcium phosphate dental paste

Group Type EXPERIMENTAL

Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste

Intervention Type DRUG

Application of CPP-ACP on one premolar once every 2 weeks for 3 months.

Interventions

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Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste

Application of CPP-ACP on one premolar once every 2 weeks for 3 months.

Intervention Type DRUG

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Maha Abd El-Monem Nasr

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maha Swelam, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Department of orthodontics

Central Contacts

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Fatma Abdou, Professor

Role: CONTACT

01006739365

Mai Abo El Fotouh, Bachelor

Role: CONTACT

01006273998

Other Identifiers

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CPP-ACP_whitespots

Identifier Type: -

Identifier Source: org_study_id

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