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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768390
• Other study ID #: 417/2007
• Secondary ID: 1212
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2013
• Last updated: January 11, 2013
• Start date: January 2008
• Est. completion date: October 2012

Study information

• Verified date: January 2013
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

not desired

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• toothpaste containing 5,000 ppm fluoride
1 cm tootpaste twice daily during 2 minutes
• 1450 GCP
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice

Locations

Country	Name	City	State
Sweden	Halland Hospital	Halmstad

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	White spot lesion incidence	Clinical scoring according to validated index	up to 24 months (at debonding of ortodontic appliances)	No
Secondary	white spot lesion severity	clinical scoring according to a validated index	up to 24 months (at debonding of orthodontic brackets)	No