Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients

Study Overview
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Brief Summary
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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
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not desired

Official Title
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Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances

Conditions
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Dental Caries

Intervention / Treatment
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* Other: toothpaste containing 5,000 ppm fluoride
* Other: 1450 GCP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5000 Test<br>Twice daily use of a toothpaste containing 5,000 ppm fluoride | Other: toothpaste containing 5,000 ppm fluoride<br>* 1 cm tootpaste twice daily during 2 minutes<br>|
| Active Comparator: 1450 GCP<br>Twice daily use of a toothpaste containing 1,450 ppm fluoride | Other: 1450 GCP<br>* Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White spot lesion incidence | Clinical scoring according to validated index | up to 24 months (at debonding of ortodontic appliances) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| white spot lesion severity | clinical scoring according to a validated index | up to 24 months (at debonding of orthodontic brackets) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caries, prevention, orthodontics, fixed appliances, adolescents