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CompletedNCT00670670Updated May 9, 2023

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

An interventional study of CPP-ACP (GC Tooth Mousse) and CPP-ACP (GC MI Paste Plus) in Early Caries Lesions, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
325
Allocation
Randomized
Ages
10 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Early Caries Lesions

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03

In context

Gingivitis

590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.

This study's enrollment of 325 is above the median of 64 across 478 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • one or more white spot lesion at the time of removal of fixed appliances

Exclusion criteria

Exclusion Criteria:

  • white spots already present before start orthodontic treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
325 participants (actual)

Study arms

  • Experimental
    1

    CPP-ACP (GC Tooth Mousse)

    Device: CPP-ACP (GC Tooth Mousse)

  • Experimental
    2

    CPP-ACP (GC MI Paste Plus)

    Device: CPP-ACP (GC MI Paste Plus)

  • No intervention
    3

    Control group

Interventions

  • DeviceCPP-ACP (GC Tooth Mousse)

    Calcium and phosphate

  • DeviceCPP-ACP (GC MI Paste Plus)

    Calcium, phosphate and fluoride

06

What researchers measure

Primary outcomes

  1. Amelioration of the opacity of white spots into a more natural tooth-like translucency

    Time frame: After 6 months

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00670670
Lead sponsor
University Hospital, Ghent
Collaborators
GC Europe
Responsible party
Sponsor
First posted
May 2, 2008
Start date
Oct 1, 2008
Primary completion
Jan 21, 2011
Completion
Apr 26, 2011
Last update
May 9, 2023

Study contacts

Guy De Pauw, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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