A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2

May 8, 2023 updated by: University Hospital, Ghent

A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2

Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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

8 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • No white spot lesion at the time of placement of fixed appliances

Exclusion Criteria:

  • White spots already present before start orthodontic treatment

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CPP-ACP (GC Tooth Mousse)
Device: CPP-ACP (GC Tooth Mousse)
Calcium and phosphate
Experimental: 2
GCC-ACP (GC MI Paste Plus)
Device: CPP-ACP (GC MI Paste Plus)
Calcium, phosphate and fluoride
Experimental: 3
Fluoride (Elmex Medical Gel)
Device: Fluoride (Elmex Medical Gel)
Fluoride
No Intervention: 4
Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevention of the opacity of white spots during orthodontic treatment with fixed appliances
Time Frame: After 2 years
After 2 years

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

GC Europe

Investigators

  • Principal Investigator: Guy De Pauw, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

October 1, 2008

Primary Completion (Actual)

January 21, 2011

Study Completion (Actual)

April 26, 2011

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/187 - Part 2

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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