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

Lecturer of Oral and Maxillofacial Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987943
Enrollment
10
Registered
2023-08-14
Start date
2023-03-21
Completion date
2023-09-21
Last updated
2023-11-21

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

Conditions

Oroantral Fistula

Keywords

oroantral fistula, A Pedicled Buccal Periosteal Flap

Brief summary

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.

Detailed description

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.

Interventions

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

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

Sponsors

Marwa Taha Ibrahim
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

patients

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. patients have oroantral fistula 2. clear maxillary sinus with no infection

Exclusion criteria

1. Patients suffering from any systemic diseases affect healing of soft tissue 2. patients have remaining roots or foreign body in sinus indicated for cald well luc opearation

Design outcomes

Primary

MeasureTime frameDescription
visual analogue scale1 month0 representing no pain and 10 representing the highest level of pain
comparison of vestibular depth preoperatively and postoperatively1 monththe vestibular depth measured from gingival margin to bottom of vestibule.
inflammation score scale1 month0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

Countries

Egypt

Outcome results

None listed

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