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

University of Copenhagen

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Other: 1450 GCP; Other: toothpaste containing 5,000 ppm fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT01768390

417/2007

1212

Details and patient eligibility

About

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.

Full description

not desired

Enrollment: 500 patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

5000 Test

Experimental group

Description:

Twice daily use of a toothpaste containing 5,000 ppm fluoride

Treatment:

Other: toothpaste containing 5,000 ppm fluoride

1450 GCP

Active Comparator group

Description:

Twice daily use of a toothpaste containing 1,450 ppm fluoride

Treatment:

Other: 1450 GCP