Objectively evaluate the chewing ability with the mixing ability test and evaluation of complaints with validated questionnaires, compared to gender and aged matched control group.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
maxillofaciale aandoeningen, mogelijk congenitaal
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification of functional and aesthetic burden in PFE patients, pilot study
for baseline parameters in further research
Secondary outcome
NA
Background summary
Primary failure of eruption (PFE) is a rare condition characterized by
non-syndromic eruption failure of primary or secondary teeth in the absence of
a mechanical obstruction. Little is known about PFE. Because of the rareness of
the condition, prevalence of 0.06% (Hanisch e.a. 2018), no large studies have
been reported.
Posterior teeth are mostly affected, resulting in a dorsal open bite which can
lead to functional problems such as inability to chew or aesthetic impairment
in most severe cases. It can occur in one or multiple dental quadrants. No
studies have been performed regarding patient reported outcomes and chewing
ability. Treatment is limited due to tooth mobility problems as soon as braces
are placed, resulting in ankylosis.
It is hypothesised that patients with PFE experience more problems with
chewing, which can result in Temporal Mandibular Joint problems/pain and
limitations in the type of food that can be consumed.
Study objective
Objectively evaluate the chewing ability with the mixing ability test and
evaluation of complaints with validated questionnaires, compared to gender and
aged matched control group.
Study design
A pilot study with 10 patients with known PFE and 10 control subjects (gender
and age matched).
Study burden and risks
There is a limited burden since the requested information will be obtained
during 1 visit. There are no risks associated to the questionnaires. There is a
neglectable risk associated with the chewing ability test (for example:
accidental swallowing of the wax tablet, with no clinical consequences).
There is no direct benefit to the individual participants. There is an expected
potential benefit for new patients as this pilot study can lead to further
insight in functional (and aesthetic) problems in this rare condition and
subsequently specific treatment can be adjusted accordingly.
Amsterdam UMC is a designated centre for multidisciplinary advice for PFE
(combined consultation with Maxillofacial Surgeon, Maxillofacial Prosthetic
Dentist and Orthodontist). Therefore, the limited patients that are suffering
from this condition are already known in this centre and next step treatment
options are desired.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
age and gender matched
Exclusion criteria
other maxilofacial condition or previous surgery
Design
Recruitment
Medical products/devices used
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 | NL84305.018.23 |