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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
GC Europe
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00670670
First received: April 30, 2008
Last updated: December 4, 2014
Last verified: December 2014
  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 2015
Estimated Primary Completion Date: May 2015 (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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
GC Europe
Investigators
Principal Investigator: Guy De Pauw, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
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: December 4, 2014
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 December 07, 2016