NCT05987943

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

17 days

First QC Date

July 14, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

oroantral fistulaA Pedicled Buccal Periosteal Flap

Outcome Measures

Primary Outcomes (3)

  • visual analogue scale

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

    1 month

  • comparison of vestibular depth preoperatively and postoperatively

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

    1 month

  • inflammation score scale

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

    1 month

Study Arms (1)

healing.recurrence of oroanral fistula

OTHER

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

Interventions

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

healing.recurrence of oroanral fistula

Eligibility Criteria

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

You may qualify if:

  • patients have oroantral fistula
  • clear maxillary sinus with no infection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt

Tanta, 3111, Egypt

Location

Related Publications (1)

  • Ibrahim MT, Gharieb EA, Sheta MS. A pedicled buccal periosteal flap for the closure of oro-antral fistula. BMC Oral Health. 2024 Apr 10;24(1):440. doi: 10.1186/s12903-024-04217-6.

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marwa T Ibrahim, lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: patients
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 14, 2023

First Posted

August 14, 2023

Study Start

March 21, 2023

Primary Completion

April 7, 2023

Study Completion

September 21, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

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

Locations