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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768390
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):
Svante Twetman, 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.

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

Detailed Description:
not desired

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Study Start Date : January 2008
Primary Completion Date : July 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. White spot lesion incidence [ Time Frame: up to 24 months (at debonding of ortodontic appliances) ]
    Clinical scoring according to validated index

Secondary Outcome Measures :
  1. white spot lesion severity [ Time Frame: up to 24 months (at debonding of orthodontic brackets) ]
    clinical scoring according to a validated index

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768390

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

Responsible Party: Svante Twetman, Professor, University of Copenhagen Identifier: NCT01768390     History of Changes
Other Study ID Numbers: 417/2007
1212 ( Other Identifier: Copenhagen University )
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013

Keywords provided by Svante Twetman, University of Copenhagen:
fixed appliances

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