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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

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ClinicalTrials.gov Identifier: NCT00670618
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : May 2, 2008
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Early Caries Lesions Device: CPP-ACP (GC Tooth Mousse) Device: CPP-ACP (GC MI Paste Plus) Device: Fluoride (Elmex Medical Gel)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2008
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
Drug Information available for: Fluoride
U.S. FDA Resources

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 :
  1. Prevention of the opacity of white spots during orthodontic treatment with fixed appliances [ Time Frame: After 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670618


Contacts
Contact: Silvia Dauwe silvia.dauwe@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Guy De Pauw, MD, PhD         
Sponsors and Collaborators
University Hospital, Ghent
GC Europe
Investigators
Principal Investigator: Guy De Pauw, MD, PhD University Hospital, Ghent
More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00670618     History of Changes
Other Study ID Numbers: 2008/187 - Part 2
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Gingivitis
Dental Caries
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs