oroantral communication (OAC) oroantral fistula/perforation
Conditions
Interventions
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, a suture is at
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Fresh oroantral communication (existing less than 24 hours)
Exclusion criteria
Exclusion criteria: Oroantral communication existing for more than 24 hours. Patients who require endocarditisprophylaxis or antobiotic prophylaxis for other indications. A history of acute or chronic sinusitis. Immune compromised patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the technical success, defined as the successful application of the polyurethane foam, without reoccurence of a perforation secondary to loss of the foam or inadequate fitting. The oral mucosal overgrowth will be examined to evaluate these endpoints. Safety parameters: the safety outcome of the study will be described in terms of the incidence of procedure or device related adverse events occuring up to and including 8 weeks after application in the oroantral perforation. | — |
Secondary
| Measure | Time frame |
|---|---|
| patient friendliness and device appreciation (physician) | — |
Countries
Netherlands
Outcome results
None listed