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Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy

Outpatient Clinic of Alexandria University Teaching Hospital, Egypt

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06281873
Enrollment
9
Registered
2024-02-28
Start date
2023-03-27
Completion date
2024-02-07
Last updated
2024-02-28

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

Conditions

Oroantral Fistula

Brief summary

the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis.

Detailed description

This study was conducted on nine eligible patients who complained of OAF with odontogenic sinusitis. Oral fistulectomy was done with proper curettage. Then, EMMA was performed with simultaneous closure of the OAF by application of PRF membrane and covering it with an acrylic splint. Patients were clinically evaluated for closure of the OAF after 14th days postoperatively, relief of the symptoms, and assessment of the pain level. Also, measurement of the size of the bone defect with the aid of computed tomography (CT) preoperatively and 24th weeks postoperatively.

Interventions

PROCEDUREclosure by PRF membrane

Oral fistulectomy was done with proper curettage. EMMA was performed. closure of the OAF by application of PRF membrane and covering it with an acrylic splint

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1 - Adult patients between the ages of 20-60 years. 2- Patients who were suffering from chronic fistula that occurred after the extraction of upper posterior teeth

Exclusion criteria

1. patients who have any systemic disease that contraindicates any intervention under general anesthesia (e.g., coronary artery disease). 2. OAF that occurred as a result of other causes (e.g., cyst,and trauma)

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the soft tissue wound's healing1st, 7th, and14 days postoperativelyclosure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5

Secondary

MeasureTime frameDescription
Secondary radiographic outcomes, assessment of bone formation24 weeks postoperativelyMeasurement of the size of the defect with CT size measured by millimeters (mm)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026