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CompletedNCT06044012Updated Aug 13, 2024

Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula

An interventional study of Double layer of buccal myomucosal Flap and buccal pad of fat in Oro-Antral Communication, sponsored by Tanta University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Oro-Antral Communication

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Keywords

  • Oro-Antral Fistula
  • Buccal pad of fat
  • Myomucosal Flap
03

In context

Fistula

731 studies on the registry are indexed under Fistula; 103 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 484 interventional studies indexed under Fistula.

Browse Fistula studies →

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Large Oro-antral Fistula
  • Recent or previously failed closure of oro-antral Fistula

Exclusion criteria

Exclusion Criteria:

  • Immuno-supressed patients
  • fistulae smaller than 5 mm in size
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Patients with large Oro-antral Fistula

    closure of oro-antral fistula by myomucosal flap and buccal pad of fat

    Procedure: Double layer of buccal myomucosal Flap and buccal pad of fat

Interventions

  • ProcedureDouble layer of buccal myomucosal Flap and buccal pad of fat

    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.

06

What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 6 months

Secondary outcomes

  1. infection

    fluid level will be measured in cubic centimeter in computed tomography

    Time frame: 6 months

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Study locations

1 site
  • Faculty of Dentistry, Tanta University
    Tanta, 31773, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06044012
Lead sponsor
Tanta University
Responsible party
Ahmed Abdellatif Abdelfatah (Lecturer of oral and maxillofacial surgery, Tanta University) — Principal investigator
First posted
Sep 21, 2023
Start date
Jun 1, 2023
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024
Last update
Aug 13, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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