A Prospective, Randomized Clinical Study on the Effects of NCT00670670

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

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

Recruitment information / eligibility
Status	Completed
Enrollment	325
Est. completion date	April 26, 2011
Est. primary completion date	January 21, 2011
Accepts healthy volunteers	No
Gender	All
Age group	10 Years to 60 Years
Eligibility	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

Device:
• CPP-ACP (GC Tooth Mousse)
Calcium and phosphate
• CPP-ACP (GC MI Paste Plus)
Calcium, phosphate and fluoride

Locations
Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors *(2)*
Lead Sponsor	Collaborator
University Hospital, Ghent	GC Europe

Belgium,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Amelioration of the opacity of white spots into a more natural tooth-like translucency		After 6 months

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00670618` - 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	N/A