Oroantral FistulaNCT06281873
Closure of Oroantral Fistula (OAF) Using Platelet Rich Fibrin With Middle Meatal Antrostomy
A study testing closure by PRF membrane in people with Oroantral Fistula, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oroantral Fistula
- What is being tested?
- closure by PRF membrane
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Mar 2023to 7 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Clinic of Alexandria University Teaching Hospital, Egypt
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.
Read the detailed description
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
- Oroantral Fistula
- Being tested
- closure by PRF membrane
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closure by PRF membraneProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| closure of the OAF with PRF application | Experimental | This study was conducted on 9 patients. application of PRF membrane Receives: Procedure: closure by PRF membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the soft tissue wound's healing
closure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5
Measured: 1st, 7th, and14 days postoperatively
Secondary outcomes (1)
Secondary radiographic outcomes, assessment of bone formation
Measurement of the size of the defect with CT size measured by millimeters (mm)
Measured: 24 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start27 Mar 2023
- Primary completion1 Sep 2023
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oroantral FistulaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MONA SAMY, PHD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281873
- Sponsor's protocol ID
- 0645
- Status last verified
- Mar 2023
- First submitted
- 12 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38880902
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Clinic of Alexandria University Teaching Hospital, Egypt
- ClinicalTrials.gov ID
- NCT06281873
- Acronym / sponsor ID
- 0645
- Conditions
- Oroantral Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| closure of the OAF with PRF application | Experimental | Procedure: closure by PRF membraneThis study was conducted on 9 patients. application of PRF membrane |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closure by PRF membraneOral 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 | Procedure or surgery | closure of the OAF with PRF application |
Primary outcome
Evaluation of the soft tissue wound's healing
Time frame: 1st, 7th, and14 days postoperatively
closure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5
1 secondary outcome
Secondary radiographic outcomes, assessment of bone formation
Time frame: 24 weeks postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 38880902Elgabarty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MONA SAMY, PHD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closure by PRF membrane in people with Oroantral Fistula, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the soft tissue wound's healing (time frame: 1st, 7th, and14 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.