Our aim is to find methods to effectively reduce the caries incidence during orthodontic treatment with fixed appliances. A secondary aim is to study the effect of fixed orthodontic appliances on the plaque ecology in relation to caries development…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cariës
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of caries lesions as found by visual inspection, extent of lesions
expressed by their fluorescence loss and lesion area (QLF).
Secondary outcome
plaque composition and aciduricity.
Background summary
In a previous study (approved AMC MEC01/099#01.17.594) we found that 97% of
study participants had caries on the buccal surfaces after removal of fixed
appliances, with on average 30% of buccal surfaces affected[Boersma et al.,
2005]. Forty-nine percent of caries lesions remained as permanent scars while
fifteen percent of lesions had received or were in need of restorative care 2
years into the retention period[Mattousch et al., 2007]. No clear evidence
exists on which preventive measures are effective in reducing caries incidence
in this specific patient population, or how to reminisce caries that has
developed during orthodontic treatment[Benson et al., 2005].
Study objective
Our aim is to find methods to effectively reduce the caries incidence during
orthodontic treatment with fixed appliances. A secondary aim is to study the
effect of fixed orthodontic appliances on the plaque ecology in relation to
caries development.
Study design
The study will be performed as a double blinded randomized clinical trial.
Intervention
Participants during treatment with orthodontic appliances will be put on a
rigid oral hygiene program with regularly available fluoride rinse (elmex
CARIES PROTECTION dental rinse), or rigid oral hygiene supplemented with a
placebo rinse without fluoride.
Study burden and risks
Subjects treated with fixed orthodontic appliances are at increased caries risk
and the caries progresses faster than normal. For this specific type of
lesions, little evidence on the most effective way of caries prevention and
remineralization exists. The predominant cause for caries is believed to be a
lack of adequate oral hygiene. The patients volunteering as participants in the
study are expected to benefit from an enforced oral hygiene, given them extra
attention at the loss of some time, which should result in less caries.
Grabetsmattweg
CH-4106 Therwil
CH
Grabetsmattweg
CH-4106 Therwil
CH
Listed location countries
Age
Inclusion criteria
* 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).
Exclusion criteria
* 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
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 |
|---|---|
| CCMO | NL26663.029.09 |