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

Closure of oroantral communications using a biodegradable polyurethane foam; a feasibility study - the "RAPID" study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31277

Enrollment

Registered

2007-10-11

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oroantral communication (OAC) oroantral fistula/perforation

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, the foam is fi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: fresh oroantral communication (existing less then 48 hours)

Exclusion criteria

Exclusion criteria: oroantral communication existing for more then 48 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, inflammation 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.	—

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, inflammation 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

Source: NL-OMON (via WHO ICTRP)