Biodegradable polyurethane foam modified with 55% polyethyleneglycol as a local hemostatic agent, a pilot study.

Like in any kind of surgery, extraction of teeth can result in (postoperative)
bleeding. Such bleeding can be treated by means of a local hemostatic agent.
Patients who use oral anticoagulant therapy require to stop the anticoagulant
therapy prior to surgery to prevent postoperative bleeding after tooth
extractions. However, ceasing the use of these drugs increases the risk of
thromboembolic events. With the use of local hemostatic agents after dental
extractions to control local bleeding, the risk of such thromboembolic events
could be diminished.
In dentistry, local hemostatic agents are already used for application in
sockets after extraction. Until now, these local hemostatic agents are of
animal derived origin. Transmission of pathogens might be a possible
complication of these products. Therefore, attention is currently focused on
local hemostatic agents that are fully synthetic. It is anticipated that these
synthetic foams can be used in all patients, including patients on
anticoagulant therapy.
Polyurethane foam modified with 55% polyethyleneglycol is a fully synthetic
foam, and it has proven to be both biodegradable and biocompatible.

Goal of this study is to asses the feasibility of polyurethane foam as a local
hemostatic agents in sockets after dental extraction. The assessment will take
place in a small number of patients.
After the pilot study, a large study will be implemented to evaluate the
polyurethane foam as a local hemostatic agent in all patients, including
patients on anticoagulant therapy.
On the long term, the objective of the study is the clinical appliance of
polyurethane foam as a local hemostatic agent in all patients.

This splitmouth experiment represents the pilot phase of the study design.
During the pilot phase, the feasibility of polyurethane foam modified with 55%
PEG as a local hemostatic agent wil be examined in 10 patients. During the
pilot phase, each patient who requires at least 2 extractions in 1 session will
be examined and included in the study when all inclusion criteria are met.
Secondly, all selected patients will be treated by means of the protocol until
a total number of 10 patients is reached.

The selected patients will be divided into two groups. In the first group the
degree of clotformation in polyurethane foam will be compared to the degree of
clotformation in Willospon (absorbable gelatine sponge; Will-Pharma BV,
Zwanenburg, Nederland). In the second group the degree of clotformation in
polyurethane foam will be compared to the degree of clotformation in Novacol (
absorbable collagen hemostat; Bioprof BV, Moerkapelle, Nederland). Novacol and
Willospon are already used as local hemostatic agents in the dentistry. Only 1
kind of foam will be tested in each socket.

To our point of view the proposed stategy implies both a minimal risk and
burden for the patients. Firstly, the time needed for the treatment will not
take longer than the original treatment. Secondly, the foams are removed in the
same session. Participation in this study does not have consequences for the
number of policlinical visits.