Our aim is to find methods to effectively remineralize caries lesions that have developed during orthodontic treatment. A secondary aim is to study the effect of fixed orthodontic appliances on the plaque ecology in relation to caries development in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
caries
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of Caries lesions, change in lesion extent expressed by their
fluorescence loss and lesion area over a one-year study period.
Secondary outcome
Plaque composition and acidogenicity
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 to remineralize caries that
has developed during orthodontic treatment.
Study objective
Our aim is to find methods to effectively remineralize caries lesions that have
developed during orthodontic treatment. A secondary aim is to study the effect
of fixed orthodontic appliances on the plaque ecology in relation to caries
development in this patient population.
Study design
The study will be performed as a double blind randomized clinical trial.
Intervention
Participants with caries on the buccal surfaces upon removal of the fixed
appliances will be put on a rigid oral hygiene program. One-half of subjects
will also receive a a paste containing Casein Phosphopeptide-Amorphous Calcium
Phosphate (CPP-ACP) and fluoride for daily use at home. The other half of
subjects will receive a placebo paste.
Study burden and risks
Subjects treated with fixed orthodontic appliances are at increased caries risk
and the caries progresses faster than normal. After removal of the fixed
appliances the caries lesions only limited improvements are seen. For this
specific type of lesions, little evidence on the most effective way of caries
remineralization exists. 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 (oral hygiene instructions, when necessary
cleaning) allowing for active remineralization of existing lesions. The CPP-ACP
paste with fluoride may enhance the effect of rigid oral hygiene on
remineralization.
Louwesweg 1
1066EA Amsterdam
NL
Louwesweg 1
1066EA Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Subject is enrolled as patient at the orthodontic clinic of ACTA,
and receives orthodontic treatment with fixed appliances and is scheduled for debracketing.
Subject is between 12 and 18 years old at the start of the study.
Subject, and also a parent or guardian, have signed the informed consent form prior to the start of the study.
Subjects have at least two detectable caries lesions on their buccal surfaces immediately after debracketing.
Exclusion criteria
Subject is younger than 12 years old or older than 18 years old.
Subject is mentally not capable to understand and follow instructions.
Subject suffers from a systemic illness.
Subject is milk protein intolerant, because this may provoke an allergic reaction to the CPP-ACP paste.
Subject has caries lesions that need restorative care.
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 | NL19226.029.07 |