NCT06044012

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

May 8, 2023

Last Update Submit

August 10, 2024

Conditions

Oro-Antral Communication

Keywords

Oro-Antral FistulaBuccal pad of fatMyomucosal Flap

Outcome Measures

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 .

    6 months

Secondary Outcomes (1)

  • infection

    6 months

Study Arms (1)

Patients with large Oro-antral Fistula

EXPERIMENTAL

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

Double layer of buccal myomucosal Flap and buccal pad of fatPROCEDURE

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.

Patients with large Oro-antral Fistula

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, 31773, Egypt

Location

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral FistulaMouth DiseasesStomatognathic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of oral and maxillofacial surgery

Study Record Dates

First Submitted

May 8, 2023

First Posted

September 21, 2023

Study Start

June 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

EG(1)