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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Svante Twetman, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01768390
First received: January 4, 2013
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Dental Caries
 Other: toothpaste containing 5,000 ppm fluoride
Other: 1450 GCP
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • White spot lesion incidence [ Time Frame: up to 24 months (at debonding of ortodontic appliances) ] [ Designated as safety issue: No ]
    Clinical scoring according to validated index


Secondary Outcome Measures:
  • white spot lesion severity [ Time Frame: up to 24 months (at debonding of orthodontic brackets) ] [ Designated as safety issue: No ]
    clinical scoring according to a validated index


Enrollment: 500
Study Start Date: January 2008
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5000 Test
Twice daily use of a toothpaste containing 5,000 ppm fluoride
 Other: toothpaste containing 5,000 ppm fluoride
1 cm tootpaste twice daily during 2 minutes
Active Comparator: 1450 GCP
Twice daily use of a toothpaste containing 1,450 ppm fluoride
 Other: 1450 GCP
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice

Detailed Description:

not desired

  Eligibility

Ages Eligible for Study:   11 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768390

Locations
Sweden
Halland Hospital
Halmstad, Sweden, 30185
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Svante HA Twetman, professor University of Copenhagen
  More Information

No publications provided

Responsible Party: Svante Twetman, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01768390     History of Changes
Other Study ID Numbers: 417/2007, 1212
Study First Received: January 4, 2013
Last Updated: January 11, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Copenhagen:
caries
prevention
orthodontics
fixed appliances
adolescents

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
 Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013