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 2
Sponsor
University Hospital, Ghent (Other)
Overall Status
Unknown status
CT.gov ID
NCT00670618
Collaborator
GC Europe (Industry)
400
1
4
83
4.8
Study Details
Study Description
Brief Summary
Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
400 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 2
Study Start Date
:
Jun 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 GCC-ACP (GC MI Paste Plus) |
Device: CPP-ACP (GC MI Paste Plus)
Calcium, phosphate and fluoride
|
| Experimental: 3 Fluoride (Elmex Medical Gel) |
Device: Fluoride (Elmex Medical Gel)
Fluoride
|
| No Intervention: 4 Control group |
Outcome Measures
Primary Outcome Measures
- Prevention of the opacity of white spots during orthodontic treatment with fixed appliances [After 2 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- No white spot lesion at the time of placement 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:
NCT00670618
Other Study ID Numbers:
- 2008/187 - Part 2
First Posted:
May 2, 2008
Last Update Posted:
Dec 5, 2014
Last Verified:
Dec 1, 2014