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

NCT01768390 | Completed Phase 4

• 2 other identifiers: 417/20071212
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

caries; prevention; orthodontics; fixed appliances; adolescents

Outcome Measures

Primary Outcomes (1)

• White spot lesion incidence

  Clinical scoring according to validated index

  up to 24 months (at debonding of ortodontic appliances)

Secondary Outcomes (1)

• white spot lesion severity

  up to 24 months (at debonding of orthodontic brackets)

Study Arms (2)

5000 Test

EXPERIMENTAL

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

Other: toothpaste containing 5,000 ppm fluoride

1450 GCP

ACTIVE COMPARATOR

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

Other: 1450 GCP

Interventions

toothpaste containing 5,000 ppm fluoride OTHER

1 cm tootpaste twice daily during 2 minutes

5000 Test

1450 GCP OTHER

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

1450 GCP

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• healthy
• bi-maxillary treatment with fixed orthodontic appliances for at least 1 year

You may not qualify if:

• poor oral hygiene (not being able to brush their teeth)
• recent high caries activity

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Halland Hospital

Halmstad, 30185, Sweden

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Svante HA Twetman, professor

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 15, 2013
• Study Start: January 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

SE (1)