Back to resultsBuccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula
Primary Purpose
Oro-Antral Communication
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Double layer of buccal myomucosal Flap and buccal pad of fat
Sponsored by
About this trial
This is an interventional treatment trial for Oro-Antral Communication focused on measuring Oro-Antral Fistula, Buccal pad of fat, Myomucosal Flap
Eligibility Criteria
Inclusion Criteria: Large Oro-antral Fistula Recent or previously failed closure of oro-antral Fistula Exclusion Criteria: Immuno-supressed patients fistulae smaller than 5 mm in size
Sites / Locations
- Faculty of Dentistry, Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with large Oro-antral Fistula
Arm Description
closure of oro-antral fistula by myomucosal flap and buccal pad of fat
Outcomes
Primary Outcome Measures
Healing
The size of fistula will be clinically measured by digital caliper in centimeter for preoperative and postoperative for uneventful wound healing and disappearance of fistula .
Secondary Outcome Measures
infection
fluid level will be measured in cubic centimeter in computed tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06044012
Brief Title
Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula
Official Title
Double Layer of Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Large Oro-antral Fistula
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oro-Antral Communication
Keywords
Oro-Antral Fistula, Buccal pad of fat, Myomucosal Flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with large Oro-antral Fistula
Arm Type
Experimental
Arm Description
closure of oro-antral fistula by myomucosal flap and buccal pad of fat
Intervention Type
Procedure
Intervention Name(s)
Double layer of buccal myomucosal Flap and buccal pad of fat
Intervention Description
The buccal myomucosal flap will be harvested from cheek below stenson papilla and will be sutured over buccal pad of fat which will be sutured at palatal mucosa after complete curettage of infected fistulous tract.
Primary Outcome Measure Information:
Title
Healing
Description
The size of fistula will be clinically measured by digital caliper in centimeter for preoperative and postoperative for uneventful wound healing and disappearance of fistula .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
infection
Description
fluid level will be measured in cubic centimeter in computed tomography
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Large Oro-antral Fistula
Recent or previously failed closure of oro-antral Fistula
Exclusion Criteria:
Immuno-supressed patients
fistulae smaller than 5 mm in size
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Mosleh, PhD
Phone
0201094279620
Email
ahmed_mosleh@dent.tanta.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, Tanta University
City
Tanta
ZIP/Postal Code
31773
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A AbdEllatif, PhD
Phone
01094279620
Email
drahmed_maxillofacial@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula
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