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

NCT ID: NCT05987943

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-09-21

Brief Summary

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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

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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.

Conditions

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Oroantral Fistula

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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healing.recurrence of oroanral fistula

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

Group Type OTHER

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marwa Taha Ibrahim

OTHER

Sponsor Role lead

Responsible Party

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Marwa Taha Ibrahim

principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marwa T Ibrahim, lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Egypt

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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Ibrahim MT, Gharieb EA, Sheta MS. A pedicled buccal periosteal flap for the closure of oro-antral fistula. BMC Oral Health. 2024 Apr 10;24(1):440. doi: 10.1186/s12903-024-04217-6.

Reference Type DERIVED
PMID: 38600501 (View on PubMed)

Other Identifiers

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R-OS-9-22-6

Identifier Type: -

Identifier Source: org_study_id