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Fluoride rinse for caries prevention in orthodontics.

The use of fluoride rinse for caries prevention during the orthodontic treatment with fixed appliances.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24509
Enrollment
120
Registered
2009-05-15
Start date
2009-05-25
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

caries development during orthodontic treatment with fixed appliances.

Interventions

Elmex Cariesportection fluoride rinse and a placebo rinse.

Sponsors

GABA international
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
1. Caries incidence; 2. Plaque ecology shifts.

Secondary

MeasureTime frame
1. Caries pathogens; 2. Bleeding score; 3. Caries severity.

Contacts

Public ContactM.H. Veen, van der
m.vd.veen@acta.nl+31-(0)20 5188437

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)