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Completed

NCT Number: NCT06281873

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

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.

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Key information

Conditions

Oroantral Fistula Fistula Mouth Diseases Oral Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Alexandria, 562589, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

closure by PRF membrane

Procedure

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

Primary outcomes

  1. Evaluation of the soft tissue wound's healing

    Time frame: 1st, 7th, and14 days postoperatively

    closure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5

Secondary outcomes

  1. Secondary radiographic outcomes, assessment of bone formation

    Time frame: 24 weeks postoperatively

    Measurement of the size of the defect with CT size measured by millimeters (mm)

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Outpatient Clinic of Alexandria University Teaching Hospital, Egypt

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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