oroantral communication (OAC) oroantral fistula/perforation
Conditions
Interventions
All included patients 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 safety-suture
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 years or older. 2.The patient requires a (surgical) treatment for an oroantral communication. 3.The period between occurrence of the oroantral communication and treatment is less than 24 hours. 4.The patient is willing and able to comply with the specified follow-up evaluation. 5.The patient or legally authorized representative must provide written informed consent prior to the procedure
Exclusion criteria
Exclusion criteria: 1. Patients who require endocarditis prophylaxis or antibiotic prophylaxis for other indications. 2. Patients associated with infections at the time of intervention. 3. The period between occurrence of the oroantral communication and treatment is more than 24 hours. 4. Patients with a history of past or present immunosuppressive condition, either due to a disease or immunosuppressive medication. 5. Inflammation at the site of the antral perforation. 6. Patients enrolled in this or other clinical trial or anticipated to be included into a trial, which may interfere with this study. 7. Patients with acute or chronic maxillary sinusitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the study is the technical success of each treatment, defined as the successful application of the PU foam, without recurrence of the perforation. The oral mucosal overgrowth mucosa will be examined to evaluate this endpoint and the patient will be asked to gently blow his/her nose to make sure no air can pass through the perforation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The VAS-pain score will be documented in every visit. Also, patient satisfaction and complications like maxillary sinusitis and complicated wound healing will be documented. | — |
Countries
Netherlands
Outcome results
None listed