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
1 other identifier
interventional
325
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 2, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2011
CompletedMay 9, 2023
May 1, 2023
2.3 years
April 30, 2008
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Amelioration of the opacity of white spots into a more natural tooth-like translucency
After 6 months
Study Arms (3)
1
EXPERIMENTALCPP-ACP (GC Tooth Mousse)
2
EXPERIMENTALCPP-ACP (GC MI Paste Plus)
3
NO INTERVENTIONControl group
Interventions
Eligibility Criteria
You may qualify if:
- one or more white spot lesion at the time of removal of fixed appliances
You may not qualify if:
- white spots already present before start orthodontic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- GC Europecollaborator
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Guy De Pauw, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 2, 2008
Study Start
October 1, 2008
Primary Completion
January 21, 2011
Study Completion
April 26, 2011
Last Updated
May 9, 2023
Record last verified: 2023-05