Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
|ClinicalTrials.gov Identifier: NCT01768390|
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : January 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Other: toothpaste containing 5,000 ppm fluoride Other: 1450 GCP||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances|
|Study Start Date :||January 2008|
|Primary Completion Date :||July 2012|
|Study Completion Date :||October 2012|
Experimental: 5000 Test
Twice daily use of a toothpaste containing 5,000 ppm fluoride
Other: toothpaste containing 5,000 ppm fluoride
1 cm tootpaste twice daily during 2 minutes
Active Comparator: 1450 GCP
Twice daily use of a toothpaste containing 1,450 ppm fluoride
Other: 1450 GCP
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
- White spot lesion incidence [ Time Frame: up to 24 months (at debonding of ortodontic appliances) ]Clinical scoring according to validated index
- white spot lesion severity [ Time Frame: up to 24 months (at debonding of orthodontic brackets) ]clinical scoring according to a validated index
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768390
|Halmstad, Sweden, 30185|
|Principal Investigator:||Svante HA Twetman, professor||University of Copenhagen|