The use of fluoride rinse for caries prevention during the orthodontic treatment with fixed appliances
- Conditions
- cariësCariëstooth decay
- Registration Number
- NL-OMON33004
- Lead Sponsor
- GABA International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
* Subject is enrolled as patient at the orthodontic clinic of ACTA,
* Subject is scheduled to receive orthodontic treatment with fixed appliances for a period of at least one year.
* Subject is between 10 and 18 years old at the start of the study.
* Subject is in general good health except for the orthodontic treatment need.
* Subject, and also parents or guardian, have signed an informed consent form prior to the start of the study.
* 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).
* Subject is younger than 12 years old or older than 18 years old at start of the study.
* Subject is mentally not capable to understand and follow instructions.
* Subject has received orthodontic treatment with fixed appliances before.
* Subject suffers from a systemic illness.
* Subject suffers from caries in need of restorative care on the buccal surfaces.
* Subject uses other fluoride-containing products
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of caries lesions as found by visual inspection, extent of lesions<br /><br>expressed by their fluorescence loss and lesion area (QLF).</p><br>
- Secondary Outcome Measures
Name Time Method <p>plaque composition and aciduricity.</p><br>