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

June 13, 2017 updated by: Maha Abd El-Monem Nasr, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on enamel surface color
Time Frame: 3 months
Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II
3 months
Effect on enamel surface
Time Frame: 3 mnths
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
Time Frame: 3 months
Assessment of the effect of CPP-ACP on enamel surface texture using scanning electron microscope
3 months
Microhardnes
Time Frame: 3 months
Assessment of the effect of CPP-ACP on enamel microhardness using Vickers hardness test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Maha Swelam, Bachelor, Department of Orthodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (Actual)

June 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP-ACP_whitespots

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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