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 February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
GC Europe, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00670670
First received: April 30, 2008
Last updated: February 1, 2013
Last verified: February 2013
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:


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: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CPP-ACP (GC Tooth Mousse)
Device: CPP-ACP (GC Tooth Mousse)
Calcium and phosphate
Experimental: 2
CPP-ACP (GC MI Paste Plus)
Device: CPP-ACP (GC MI Paste Plus)
Calcium, phosphate and fluoride
No Intervention: 3
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, Belgium
Investigators
Principal Investigator: Guy De Pauw, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00670670     History of Changes
Other Study ID Numbers: 2008/187 - Part 1
Study First Received: April 30, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Gingivitis
Dental Caries
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on April 17, 2014