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 1

NCT ID: NCT00670670

Last Updated: 2023-05-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-01

Study Completion Date

2011-04-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in orthodontic patients after removal of the fixed appliances.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Early Caries Lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

CPP-ACP (GC Tooth Mousse)

Group Type EXPERIMENTAL

CPP-ACP (GC Tooth Mousse)

Intervention Type DEVICE

Calcium and phosphate

2

CPP-ACP (GC MI Paste Plus)

Group Type EXPERIMENTAL

CPP-ACP (GC MI Paste Plus)

Intervention Type DEVICE

Calcium, phosphate and fluoride

3

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CPP-ACP (GC Tooth Mousse)

Calcium and phosphate

Intervention Type DEVICE

CPP-ACP (GC MI Paste Plus)

Calcium, phosphate and fluoride

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* one or more white spot lesion at the time of removal of fixed appliances

Exclusion Criteria

* white spots already present before start orthodontic treatment
Minimum Eligible Age

10 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GC Europe

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guy De Pauw, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Related Links

Access external resources that provide additional context or updates about the study.

http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008/187 - Part 1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.