No registrations found.
ID
Source
Brief title
Health condition
caries development during orthodontic treatment with fixed appliances.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Caries incidence;
2. Plaque ecology shifts.
Secondary outcome
1. Caries pathogens;
2. Bleeding score;
3. Caries severity.
Background summary
N/A
Study objective
Fluoride rinse helps prevent caries more than optimal tooth cleaning alone.
Study design
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.
Intervention
Elmex Cariesportection fluoride rinse and a placebo rinse.
Academic Centre for Dentistry Amsterdam, Department of Cariology,
Louwesweg 1
Amsterdam 1066 EA
The Netherlands
+31-(0)20 5188437
m.vd.veen@acta.nl
Academic Centre for Dentistry Amsterdam, Department of Cariology,
Louwesweg 1
Amsterdam 1066 EA
The Netherlands
+31-(0)20 5188437
m.vd.veen@acta.nl
Inclusion criteria
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).
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1707 |
| NTR-old | NTR1817 |
| Other | METc VU / ABR / ORTCAR : 026/09 / NL26663.029.09 / 2008-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |