NCT06281873

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

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 27, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

February 12, 2024

Last Update Submit

February 20, 2024

Conditions

Oroantral Fistula

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the soft tissue wound's healing

    closure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5

    1st, 7th, and14 days postoperatively

Secondary Outcomes (1)

  • Secondary radiographic outcomes, assessment of bone formation

    24 weeks postoperatively

Study Arms (1)

closure of the OAF with PRF application

EXPERIMENTAL

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

Procedure: closure by PRF membrane

Interventions

closure by PRF membranePROCEDURE

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

closure of the OAF with PRF application

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Alexandria, 562589, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 38880902DERIVED

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

  • MONA SAMY, PHD

    Alexandria University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 28, 2024

Study Start

March 27, 2023

Primary Completion

September 1, 2023

Study Completion

February 7, 2024

Last Updated

February 28, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)