NCT00670618

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2011

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

April 30, 2008

Last Update Submit

May 8, 2023

Conditions

Early Caries Lesions

Outcome Measures

Primary Outcomes (1)

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

    After 2 years

Study Arms (4)

1

EXPERIMENTAL

CPP-ACP (GC Tooth Mousse)

Device: CPP-ACP (GC Tooth Mousse)

2

EXPERIMENTAL

GCC-ACP (GC MI Paste Plus)

Device: CPP-ACP (GC MI Paste Plus)

3

EXPERIMENTAL

Fluoride (Elmex Medical Gel)

Device: Fluoride (Elmex Medical Gel)

4

NO INTERVENTION

Control group

Interventions

CPP-ACP (GC Tooth Mousse)DEVICE

Calcium and phosphate

1
CPP-ACP (GC MI Paste Plus)DEVICE

Calcium, phosphate and fluoride

2
Fluoride (Elmex Medical Gel)DEVICE

Fluoride

3

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • White spots already present before start orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Guy De Pauw, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2008

First Posted

May 2, 2008

Study Start

October 1, 2008

Primary Completion

January 21, 2011

Study Completion

April 26, 2011

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

BE(1)