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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03187548

Enrollment

Registered

2017-06-15

Start date

2017-07-31

Completion date

2018-01-31

Last updated

2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enamel Hypomineralization, White Spot Lesion

Keywords

WSL, CPP-ACP

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.

Interventions

DRUGCasein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactFatma Abdou, Professor

Fatmaabdou@yahoo.com01006739365

Backup ContactMai Abo El Fotouh, Bachelor

Maha.swelam@gmail.com01006273998

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026