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Completed

NCT Number: NCT05987943

A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

The aim of this study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egypt

Tanta, 3111, Egypt

About this study

Background: Oroantral fistula (OAF) is a pathological communication between the oral cavity and the maxillary sinus. A variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. To increase the success rates of OAF closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity.

Purpose: The aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

Patients & Methods: Ten patients with oroantral fistula will be included in this study. The patients will be examined and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.

Preoperative evaluation: It will include the collection of demographic data, medical status and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of fluid, infection and previous surgical closure attempts). Cone beam computed tomography (CBCT) scan will be performed to determine the size of the underlying bony defect.

Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will transected at the bone level, the pedicled deep periosteal layer will be dissected and turned over the fistula at the bone level and will be stabilized using sutures. The superficial layer will be returned to its original position and sutured.

Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation and recurrences.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients have oroantral fistula
  • clear maxillary sinus with no infection

Exclusion criteria

  • Patients suffering from any systemic diseases affect healing of soft tissue
  • patients have remaining roots or foreign body in sinus indicated for cald well luc opearation

Treatment and study plan

A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

Procedure

A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula

Primary outcomes

  1. visual analogue scale

    Time frame: 1 month

    0 representing no pain and 10 representing the highest level of pain

  2. comparison of vestibular depth preoperatively and postoperatively

    Time frame: 1 month

    the vestibular depth measured from gingival margin to bottom of vestibule.

  3. inflammation score scale

    Time frame: 1 month

    0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

Sponsors and collaborators

Lead sponsor

Marwa Taha Ibrahim

Other

Registry information

Official study title

Lecturer of Oral and Maxillofacial Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Nov 21, 2023

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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