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

Not Applicable

Completed

• Conditions: Oroantral Fistula
• Interventions: Procedure: closure by PRF membrane

• Registration Number: NCT06281873
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-27
• Primary Completion: 2023-09-01
• Study Completion: 2024-02-07
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
closure of the OAF with PRF application	closure by PRF membrane	This study was conducted on 9 patients. application of PRF membrane

Primary Outcome Measures

Name	Time	Method
Evaluation of the soft tissue wound's healing	1st, 7th, and14 days postoperatively	closure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5

Secondary Outcome Measures

Name	Time	Method
Secondary radiographic outcomes, assessment of bone formation	24 weeks postoperatively	Measurement of the size of the defect with CT size measured by millimeters (mm)

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt