A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Primary Purpose
Oroantral Fistula
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Sponsored by
About this trial
This is an interventional treatment trial for Oroantral Fistula focused on measuring oroantral fistula, A Pedicled Buccal Periosteal Flap
Eligibility Criteria
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
Sites / Locations
- Egypt
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
healing.recurrence of oroanral fistula
Arm Description
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Outcomes
Primary Outcome Measures
visual analogue scale
0 representing no pain and 10 representing the highest level of pain
comparison of vestibular depth preoperatively and postoperatively
the vestibular depth measured from gingival margin to bottom of vestibule.
inflammation score scale
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05987943
Brief Title
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Official Title
Lecturer of Oral and Maxillofacial Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
April 7, 2023 (Actual)
Study Completion Date
September 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marwa Taha Ibrahim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oroantral Fistula
Keywords
oroantral fistula, A Pedicled Buccal Periosteal Flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
healing.recurrence of oroanral fistula
Arm Type
Other
Arm Description
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Intervention Type
Procedure
Intervention Name(s)
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Intervention Description
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Primary Outcome Measure Information:
Title
visual analogue scale
Description
0 representing no pain and 10 representing the highest level of pain
Time Frame
1 month
Title
comparison of vestibular depth preoperatively and postoperatively
Description
the vestibular depth measured from gingival margin to bottom of vestibule.
Time Frame
1 month
Title
inflammation score scale
Description
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa T Ibrahim, lecturer
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Egypt
City
Tanta
ZIP/Postal Code
3111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
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A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
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