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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Unknown status
CT.gov ID
NCT00670670
Collaborator
GC Europe (Industry)
60
1
3
82
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: CPP-ACP (GC Tooth Mousse)
  • Device: CPP-ACP (GC MI Paste Plus)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
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
Study Start Date :
Jul 1, 2008
Anticipated Primary Completion Date :
May 1, 2015
Anticipated Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Amelioration of the opacity of white spots into a more natural tooth-like translucency [After 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00670670
Other Study ID Numbers:
  • 2008/187 - Part 1
First Posted:
May 2, 2008
Last Update Posted:
Dec 5, 2014
Last Verified:
Dec 1, 2014
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2014