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 |
---|---|---|
|
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
- 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