Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
toothpaste containing 5,000 ppm fluoride
1450 GCP
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring caries, prevention, orthodontics, fixed appliances, adolescents
Eligibility Criteria
Inclusion Criteria:
- healthy
- bi-maxillary treatment with fixed orthodontic appliances for at least 1 year
Exclusion Criteria:
- poor oral hygiene (not being able to brush their teeth)
- recent high caries activity
Sites / Locations
- Halland Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
5000 Test
1450 GCP
Arm Description
Twice daily use of a toothpaste containing 5,000 ppm fluoride
Twice daily use of a toothpaste containing 1,450 ppm fluoride
Outcomes
Primary Outcome Measures
White spot lesion incidence
Clinical scoring according to validated index
Secondary Outcome Measures
white spot lesion severity
clinical scoring according to a validated index
Full Information
NCT ID
NCT01768390
First Posted
January 4, 2013
Last Updated
January 11, 2013
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01768390
Brief Title
Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
Official Title
Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed orthodontic appliances (FOA).
The null hypothesis is that neither incidence nor severity of lesions would differ from a control group using standard fluoride dentifrice.
SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4 Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the maxillary incisors, canines and premolars are taken. At debonding, remaining composite material on the surfaces is removed with a slow rotating carbide bur followed by polishing with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is thereafter exposed.
The primary outcome measure is the incidence and severity of WSL as registered separately by two blinded experienced and calibrated clinicians according to a validated index. A random sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The intervention is indended run throughout the full duration of the orthodontic treatment, varying between 18 and 24 months.
Detailed Description
not desired
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
caries, prevention, orthodontics, fixed appliances, adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5000 Test
Arm Type
Experimental
Arm Description
Twice daily use of a toothpaste containing 5,000 ppm fluoride
Arm Title
1450 GCP
Arm Type
Active Comparator
Arm Description
Twice daily use of a toothpaste containing 1,450 ppm fluoride
Intervention Type
Other
Intervention Name(s)
toothpaste containing 5,000 ppm fluoride
Intervention Description
1 cm tootpaste twice daily during 2 minutes
Intervention Type
Other
Intervention Name(s)
1450 GCP
Intervention Description
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
Primary Outcome Measure Information:
Title
White spot lesion incidence
Description
Clinical scoring according to validated index
Time Frame
up to 24 months (at debonding of ortodontic appliances)
Secondary Outcome Measure Information:
Title
white spot lesion severity
Description
clinical scoring according to a validated index
Time Frame
up to 24 months (at debonding of orthodontic brackets)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy
bi-maxillary treatment with fixed orthodontic appliances for at least 1 year
Exclusion Criteria:
poor oral hygiene (not being able to brush their teeth)
recent high caries activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svante HA Twetman, professor
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Halland Hospital
City
Halmstad
ZIP/Postal Code
30185
Country
Sweden
12. IPD Sharing Statement
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Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
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