Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
NCT ID: NCT01768390
Last Updated: 2013-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
500 participants
INTERVENTIONAL
2008-01-31
2012-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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5000 Test
Twice daily use of a toothpaste containing 5,000 ppm fluoride
toothpaste containing 5,000 ppm fluoride
1 cm tootpaste twice daily during 2 minutes
1450 GCP
Twice daily use of a toothpaste containing 1,450 ppm fluoride
1450 GCP
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
Interventions
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toothpaste containing 5,000 ppm fluoride
1 cm tootpaste twice daily during 2 minutes
1450 GCP
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
Eligibility Criteria
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Inclusion Criteria
* bi-maxillary treatment with fixed orthodontic appliances for at least 1 year
Exclusion Criteria
* recent high caries activity
11 Years
16 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Responsible Party
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Svante Twetman
Professor
Principal Investigators
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Svante HA Twetman, professor
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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Halland Hospital
Halmstad, , Sweden
Countries
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Other Identifiers
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1212
Identifier Type: OTHER
Identifier Source: secondary_id
417/2007
Identifier Type: -
Identifier Source: org_study_id
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