Fluoride rinse helps prevent caries more than optimal tooth cleaning alone.
ID
Bron
Verkorte titel
Aandoening
caries development during orthodontic treatment with fixed appliances.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Caries incidence;<br>
2. Plaque ecology shifts.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Fluoride rinse helps prevent caries more than optimal tooth cleaning alone.
Onderzoeksopzet
Just 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.
Onderzoeksproduct en/of interventie
Elmex Cariesportection fluoride rinse and a placebo rinse.
Publiek
Academic Centre for Dentistry Amsterdam, Department of Cariology,
Louwesweg 1
Amsterdam 1066 EA
The Netherlands
+31-(0)20 5188437
m.vd.veen@acta.nl
Wetenschappelijk
Academic Centre for Dentistry Amsterdam, Department of Cariology,
Louwesweg 1
Amsterdam 1066 EA
The Netherlands
+31-(0)20 5188437
m.vd.veen@acta.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1707 |
| NTR-old | NTR1817 |
| Ander register | METc VU / ABR / ORTCAR : 026/09 / NL26663.029.09 / 2008-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |