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

January 11, 2013 updated by: Svante Twetman, University of Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

not desired

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Halmstad, Sweden, 30185
        • Halland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White spot lesion incidence
Time Frame: up to 24 months (at debonding of ortodontic appliances)
Clinical scoring according to validated index
up to 24 months (at debonding of ortodontic appliances)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
white spot lesion severity
Time Frame: up to 24 months (at debonding of orthodontic brackets)
clinical scoring according to a validated index
up to 24 months (at debonding of orthodontic brackets)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Svante HA Twetman, professor, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 4, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (Estimate)

January 15, 2013

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 11, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 417/2007
  • 1212 (Copenhagen University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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