Back to resultsA 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
Primary Purpose
Early Caries Lesions
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CPP-ACP (GC Tooth Mousse)
CPP-ACP (GC MI Paste Plus)
Sponsored by
About this trial
This is an interventional treatment trial for Early Caries Lesions
Eligibility 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1
2
3
Arm Description
CPP-ACP (GC Tooth Mousse)
CPP-ACP (GC MI Paste Plus)
Control group
Outcomes
Primary Outcome Measures
Amelioration of the opacity of white spots into a more natural tooth-like translucency
Secondary Outcome Measures
Full Information
NCT ID
NCT00670670
First Posted
April 30, 2008
Last Updated
May 8, 2023
Sponsor
University Hospital, Ghent
Collaborators
GC Europe
1. Study Identification
Unique Protocol Identification Number
NCT00670670
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2008 (Actual)
Primary Completion Date
January 21, 2011 (Actual)
Study Completion Date
April 26, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
GC Europe
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Caries Lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
325 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
CPP-ACP (GC Tooth Mousse)
Arm Title
2
Arm Type
Experimental
Arm Description
CPP-ACP (GC MI Paste Plus)
Arm Title
3
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
CPP-ACP (GC Tooth Mousse)
Intervention Description
Calcium and phosphate
Intervention Type
Device
Intervention Name(s)
CPP-ACP (GC MI Paste Plus)
Intervention Description
Calcium, phosphate and fluoride
Primary Outcome Measure Information:
Title
Amelioration of the opacity of white spots into a more natural tooth-like translucency
Time Frame
After 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy De Pauw, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
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
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