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

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
GC Europe, Belgium
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00670618
First received: April 30, 2008
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Prevention of the opacity of white spots during orthodontic treatment with fixed appliances [ Time Frame: After 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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, Belgium
Investigators
Principal Investigator: Guy De Pauw, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00670618     History of Changes
Other Study ID Numbers: 2008/187 - Part 2
Study First Received: April 30, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014