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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01768390
Enrollment
500
Registered
2013-01-15
Start date
2008-01-31
Completion date
2012-10-31
Last updated
2013-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

caries, prevention, orthodontics, fixed appliances, adolescents

Brief 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.

Detailed description

not desired

Interventions

OTHERtoothpaste containing 5,000 ppm fluoride

1 cm tootpaste twice daily during 2 minutes

OTHER1450 GCP

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

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
White spot lesion incidenceup to 24 months (at debonding of ortodontic appliances)Clinical scoring according to validated index

Secondary

MeasureTime frameDescription
white spot lesion severityup to 24 months (at debonding of orthodontic brackets)clinical scoring according to a validated index

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026