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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: April 30, 2008 Last Updated: April 9, 2009 History of Changes

Sponsors and Collaborators:	University Hospital, Ghent GC Europe
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00670670

Purpose

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

Condition	Intervention
Early Caries Lesions	Device: CPP-ACP (GC Tooth Mousse) Device: CPP-ACP (GC MI Paste Plus)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1

Resource links provided by NLM:

MedlinePlus related topics: Calcium

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Amelioration of the opacity of white spots into a more natural tooth-like translucency [ Time Frame: After 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental CPP-ACP (GC Tooth Mousse)	Device: CPP-ACP (GC Tooth Mousse) Calcium and phosphate
2: Experimental CPP-ACP (GC MI Paste Plus)	Device: CPP-ACP (GC MI Paste Plus) Calcium, phosphate and fluoride
3: No Intervention Control group

Eligibility

Ages Eligible for Study:	10 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670670

Contacts

Contact: Veronique Noens

veronique.noens@ugent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Principal Investigator: Guy De Pauw, MD, PhD

Sponsors and Collaborators

University Hospital, Ghent

GC Europe

Investigators

Principal Investigator:

Guy De Pauw, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Guy De Pauw, MD, PhD )
Study ID Numbers:	2008/187 - Part 1
Study First Received:	April 30, 2008
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00670670 History of Changes
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Mouth Diseases
Calcium, Dietary
Tooth Diseases
Caseins
Periodontal Diseases

Gingival Diseases
Gingivitis
Stomatognathic Diseases
Fluorides
Dental Caries

Additional relevant MeSH terms:

Mouth Diseases
Tooth Diseases
Periodontal Diseases
Gingival Diseases

Gingivitis
Stomatognathic Diseases
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on September 03, 2009