Dental CariesPhase 4NCT01768390
Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
A Phase 4 study testing toothpaste containing 5,000 ppm fluoride and 1450 GCP in people with Dental Caries, run by University of Copenhagen at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- toothpaste containing 5,000 ppm fluoride and 1450 GCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy
- bi-maxillary treatment with fixed orthodontic appliances for at least 1 year
Who cannot join
- poor oral hygiene (not being able to brush their teeth)
- recent high caries activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
not desired
- Conditions
- Dental Caries
- Being tested
- toothpaste containing 5,000 ppm fluoride, 1450 GCP
- Keywords
- caries, prevention, orthodontics, fixed appliances, adolescents
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toothpaste containing 5,000 ppm fluorideOther
1 cm tootpaste twice daily during 2 minutes
1450 GCPOther
Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
| Study group | Role | What they receive |
|---|---|---|
| 5000 Test | Experimental | Twice daily use of a toothpaste containing 5,000 ppm fluoride Receives: Other: toothpaste containing 5,000 ppm fluoride |
| 1450 GCP | Active comparator | Twice daily use of a toothpaste containing 1,450 ppm fluoride Receives: Other: 1450 GCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
White spot lesion incidence
Clinical scoring according to validated index
Measured: up to 24 months (at debonding of ortodontic appliances)
Secondary outcomes (1)
white spot lesion severity
clinical scoring according to a validated index
Measured: up to 24 months (at debonding of orthodontic brackets)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2008
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svante Twetman, University of Copenhagen
- Investigators
- Svante HA Twetman, professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768390
- Sponsor's protocol ID
- 417/2007
- Other IDs
- 1212
- Status last verified
- Jan 2013
- First submitted
- 4 Jan 2013
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances
- ClinicalTrials.gov ID
- NCT01768390
- Acronym / sponsor ID
- 417/2007
- Conditions
- Dental Caries
- Keywords
- caries, prevention, orthodontics, fixed appliances, adolescents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
not desired
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5000 Test | Experimental | Other: toothpaste containing 5,000 ppm fluorideTwice daily use of a toothpaste containing 5,000 ppm fluoride |
| 1450 GCP | Active comparator | Other: 1450 GCPTwice daily use of a toothpaste containing 1,450 ppm fluoride |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy
- bi-maxillary treatment with fixed orthodontic appliances for at least 1 year
Key exclusion criteria (2 listed)
- poor oral hygiene (not being able to brush their teeth)
- recent high caries activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toothpaste containing 5,000 ppm fluoride1 cm tootpaste twice daily during 2 minutes | Other | 5000 Test |
| 1450 GCPTwice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice | Other | 1450 GCP |
Primary outcome
White spot lesion incidence
Time frame: up to 24 months (at debonding of ortodontic appliances)
Clinical scoring according to validated index
1 secondary outcome
white spot lesion severity
Time frame: up to 24 months (at debonding of orthodontic brackets)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svante HA Twetman, professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing toothpaste containing 5,000 ppm fluoride and 1450 GCP in people with Dental Caries, run by University of Copenhagen at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White spot lesion incidence (time frame: up to 24 months (at debonding of ortodontic appliances)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.