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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

Primary Purpose

Early Caries Lesions

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CPP-ACP (GC Tooth Mousse)
CPP-ACP (GC MI Paste Plus)
Fluoride (Elmex Medical Gel)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Caries Lesions

Eligibility Criteria

10 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • No white spot lesion at the time of placement of fixed appliances

Exclusion Criteria:

  • White spots already present before start orthodontic treatment

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1

2

3

4

Arm Description

CPP-ACP (GC Tooth Mousse)

GCC-ACP (GC MI Paste Plus)

Fluoride (Elmex Medical Gel)

Control group

Outcomes

Primary Outcome Measures

Prevention of the opacity of white spots during orthodontic treatment with fixed appliances

Secondary Outcome Measures

Full Information

First Posted
April 30, 2008
Last Updated
May 8, 2023
Sponsor
University Hospital, Ghent
Collaborators
GC Europe
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1. Study Identification

Unique Protocol Identification Number
NCT00670618
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2008 (Actual)
Primary Completion Date
January 21, 2011 (Actual)
Study Completion Date
April 26, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
GC Europe

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Caries Lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
325 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CPP-ACP (GC Tooth Mousse)
Arm Title
2
Arm Type
Experimental
Arm Description
GCC-ACP (GC MI Paste Plus)
Arm Title
3
Arm Type
Experimental
Arm Description
Fluoride (Elmex Medical Gel)
Arm Title
4
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
CPP-ACP (GC Tooth Mousse)
Intervention Description
Calcium and phosphate
Intervention Type
Device
Intervention Name(s)
CPP-ACP (GC MI Paste Plus)
Intervention Description
Calcium, phosphate and fluoride
Intervention Type
Device
Intervention Name(s)
Fluoride (Elmex Medical Gel)
Intervention Description
Fluoride
Primary Outcome Measure Information:
Title
Prevention of the opacity of white spots during orthodontic treatment with fixed appliances
Time Frame
After 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy De Pauw, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

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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