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

Sponsor
Marwa Taha Ibrahim (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05987943
Collaborator
(none)
10
1
1
6
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
patientspatients
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Lecturer of Oral and Maxillofacial Surgery
Actual Study Start Date :
Mar 21, 2023
Actual Primary Completion Date :
Apr 7, 2023
Anticipated Study Completion Date :
Sep 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: healing.recurrence of oroanral fistula

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

Outcome Measures

Primary Outcome Measures

  1. visual analogue scale [1 month]

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

  2. comparison of vestibular depth preoperatively and postoperatively [1 month]

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

  3. inflammation score scale [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Egypt Tanta Egypt 3111

Sponsors and Collaborators

  • Marwa Taha Ibrahim

Investigators

  • Principal Investigator: Marwa T Ibrahim, lecturer, Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Taha Ibrahim, principle investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT05987943
Other Study ID Numbers:
  • R-OS-9-22-6
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marwa Taha Ibrahim, principle investigator, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023