search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Fluoride rinse for caries prevention in orthodontics.


- candidate number5756
- NTR NumberNTR1817
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mei-2009
- Secondary IDs026/09 / NL26663.029.09 / 2008-01  METc VU / ABR / ORTCAR
- Public TitleFluoride rinse for caries prevention in orthodontics.
- Scientific TitleThe use of fluoride rinse for caries prevention during the orthodontic treatment with fixed appliances.
- ACRONYMN/A
- hypothesisFluoride rinse helps prevent caries more than optimal tooth cleaning alone.
- Healt Condition(s) or Problem(s) studiedCaries
- Inclusion criteria1. Subject is enrolled as patient at the orthodontic clinic of ACTA;
2. Subject is scheduled to receive orthodontic treatment with fixed appliances for a period of at least one year;
3. Subject is between 12 and 18 years old at the start of the study;
4. Subject is in general good health except for the orthodontic treatment need;
5. Subject, and also parents or guardian, have signed an informed consent form prior to the start of the study;
6. Note that all orthodontic patients, prior to treatment with fixed appliances, need to maintain oral hygiene levels such that they fall into oral hygiene class 1(good) or 2(adequate).
- Exclusion criteria1. Subject is younger than 12 years old or older than 18 years old at start of the study;
2. Subject is mentally not capable to understand and follow instructions;
3. Subject has received orthodontic treatment with fixed appliances before;
4. Subject suffers from a systemic illness;
5. Subject suffers from caries in need of restorative care on the buccal surfaces;
6. Subject uses other fluoride-containing products.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 25-mei-2009
- planned closingdate31-dec-2012
- Target number of participants120
- InterventionsElmex Cariesportection fluoride rinse and a placebo rinse.
- Primary outcome1. Caries incidence;
2. Plaque ecology shifts.
- Secondary outcome1. Caries pathogens;
2. Bleeding score;
3. Caries severity.
- TimepointsJust prior to ortho treatment with fixed appliances, 6 and 12 weeks thereafter, then every 6 months until debond, before (plaque) and after debond (caries) and 6 and 12 months thereafter.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.H. Veen, van der
- CONTACT for SCIENTIFIC QUERIES M.H. Veen, van der
- Sponsor/Initiator GABA International AG
- Funding
(Source(s) of Monetary or Material Support)
GABA International AG
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-mei-2009 - 30-sep-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl