Closure of oroantral communications using a biodegradable polyurethane foam; a feasibility study

An oroantral communication (OAC) is a communication between the oral and nasal
cavity. In general, an OAC is caused by extraction of maxillary (pre)molars.
Although the incidence is relatively low (5 %), OACs are frequently encountered
due to the high number of extractions.
To prevent chronic sinusitis and the developmentment of fistulas, it is
generally accepted that all OACs should be closed within 24 to 48 hours.
Surgical closure with a mucoperiosteal flap is the treatment of choice
nowadays. The patient has to be referref to a maxillofacial surgeon for this
surgical treatment because, in general, the dentist does not have the expertise
and the required facilities to treat the OAC himself.
Another major objective of the surgical treatment for edentulous patients is
the fact that the buccal sulcus height almost certainly decreases permanently,
thereby hindering the construction of a well-fitted dental prosthesis.
The proposed treatment with a biodegradable polyurethane foam meets this
objections because it is a quick, safe and simple strategy and does not require
additional surgical expertise. This will make it possible for a dentist to
treat an OAC himself instead of having to refer the patient to a specialist.
Furthermore, the proposed strategy has no influence on the buccal sulcus
height.
In addition, it is expected that, compared with the conventional surgical
treatment, the proposed strategy will result in less postoperative pain and
swelling. Lastly, due to the biodegradability of the polyurethane foam, a
second visit for removal of the foam is not necessary.

Goal of this study is to assess the feasibility of a biodegradable polyurethane
foam for closing of oroantral communications. The assessment will take place in
a small number of patients. On the long term, the objective is the clinical
appliance of the polyurethane foam on a large scale.

This single center study represents the pilot phase of the study design. During
the pilot phase, the feasibility of the proposed treatment will be assessed in
10 patients. During the pilot phase every patient with an OAC at the department
of oral and maxillofacial surgery of the UMCG will be examined and included in
the study when the inclusion criteria are met. Secondly, all selected patients
with an OAC will be treated with the polyurethane foam until a total number of
10 patients is reached. A prospective multi center trial will be set up when
the pilot phase has been finished

All patients (n = 10) will be treated in the same manner. The size of the
oroantral communication will be examined and a polyurethane foam is selected
that matches its size. Secondly, the foam is fitted in the perforation and
loosely secured on the oral side with one 3.0 or 4.0 vicryl suture to ensure
that the foam stays in place.

To our point of view the proposed strategy implies both a minimal risk and
burden for the patients. Firstly, it is expected that the proposed treatment is
quicker than the conventional surgical treatment. Secondly, the swelling and
postoperative pain will most likely be less prominent after the proposed
treatment. Furthermore, the most important risk associated with participation
is possible reoccurence of an OAC, for example due to loss of the foam.
However, in case an OAC reoccurs, the attending physician can fall back on the
conventional surgical strategy in any case. Lastly, the number of policlinical
visits associated with participation in this study has been restricted to a
total of three, which is only slightly more than general (2 visits).