Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy

NCT ID: NCT06281873

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-02-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was conducted on nine eligible patients who complained of OAF with odontogenic sinusitis. Oral fistulectomy was done with proper curettage. Then, EMMA was performed with simultaneous closure of the OAF by application of PRF membrane and covering it with an acrylic splint. Patients were clinically evaluated for closure of the OAF after 14th days postoperatively, relief of the symptoms, and assessment of the pain level. Also, measurement of the size of the bone defect with the aid of computed tomography (CT) preoperatively and 24th weeks postoperatively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oroantral Fistula

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

closure of the OAF with PRF application

This study was conducted on 9 patients. application of PRF membrane

Group Type EXPERIMENTAL

closure by PRF membrane

Intervention Type PROCEDURE

Oral fistulectomy was done with proper curettage. EMMA was performed. closure of the OAF by application of PRF membrane and covering it with an acrylic splint

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

closure by PRF membrane

Oral fistulectomy was done with proper curettage. EMMA was performed. closure of the OAF by application of PRF membrane and covering it with an acrylic splint

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1 - Adult patients between the ages of 20-60 years. 2- Patients who were suffering from chronic fistula that occurred after the extraction of upper posterior teeth

Exclusion Criteria

1. patients who have any systemic disease that contraindicates any intervention under general anesthesia (e.g., coronary artery disease).
2. OAF that occurred as a result of other causes (e.g., cyst,and trauma)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MONA SAMY, PHD

Role: STUDY_DIRECTOR

Alexandria University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

Elgabarty AT, Elmahallawy AS, Ibraheam AA, Oraby MS. Closure of oroantral fistula using platelet rich fibrin with endoscopic middle meatal antrostomy. BMC Oral Health. 2024 Jun 16;24(1):698. doi: 10.1186/s12903-024-04409-0.

Reference Type DERIVED
PMID: 38880902 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0645

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tissue Therapy of Transsphincteric Anal Fistula
NCT06303752 RECRUITING PHASE1/PHASE2