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

Phase 4

Completed

• Conditions: Dental Caries
• Interventions: Other: toothpaste containing 5,000 ppm fluoride; Other: 1450 GCP

• Registration Number: NCT01768390
• Lead Sponsor: University of Copenhagen

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

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-07
• Study Completion: 2012-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-11
• Last Update Submitted: 2013-01-11
• Study First Posted: 2013-01-15
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5000 Test	toothpaste containing 5,000 ppm fluoride	Twice daily use of a toothpaste containing 5,000 ppm fluoride
1450 GCP	1450 GCP	Twice daily use of a toothpaste containing 1,450 ppm fluoride

Primary Outcome Measures

Name	Time	Method
White spot lesion incidence	up to 24 months (at debonding of ortodontic appliances)	Clinical scoring according to validated index

Secondary Outcome Measures

Name	Time	Method
white spot lesion severity	up to 24 months (at debonding of orthodontic brackets)	clinical scoring according to a validated index

Trial Locations

Locations (1)

Halland Hospital; 🇸🇪 Halmstad, Sweden