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

NCT01768390 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-01-15

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

OTHER

toothpaste containing 5,000 ppm fluoride

1 cm tootpaste twice daily during 2 minutes

OTHER

1450 GCP

Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Svante HA Twetman, professor · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01768390 on ClinicalTrials.gov