Oroantral FistulaNCT05987943
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
A study testing A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula in people with Oroantral Fistula, run by Marwa Taha Ibrahim at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Oroantral Fistula
- What is being tested?
- A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2023to 21 Sep 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients have oroantral fistula
- clear maxillary sinus with no infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer of Oral and Maxillofacial Surgery
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.
Read the detailed description
Background: 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.
Purpose: The aim of this prospective 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.
Patients \& Methods: Ten patients with oroantral fistula will be included in this study. The patients will be examined and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation: It will include the collection of demographic data, medical status and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of fluid, infection and previous surgical closure attempts). Cone beam computed tomography (CBCT) scan will be performed to determine the size of the underlying bony defect.
Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will transected at the bone level, the pedicled deep periosteal layer will be dissected and turned over the fistula at the bone level and will be stabilized using sutures. The superficial layer will be returned to its original position and sutured.
Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation and recurrences.
- Conditions
- Oroantral Fistula
- Being tested
- A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
- Keywords
- oroantral fistula, A Pedicled Buccal Periosteal Flap
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral FistulaProcedure or surgery
A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
| Study group | Role | What they receive |
|---|---|---|
| healing.recurrence of oroanral fistula | Other | A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula Receives: Procedure: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
0 representing no pain and 10 representing the highest level of pain
Measured: 1 month
comparison of vestibular depth preoperatively and postoperatively
the vestibular depth measured from gingival margin to bottom of vestibule.
Measured: 1 month
inflammation score scale
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start21 Mar 2023
- Primary completion7 Apr 2023
- Study completion21 Sep 2023
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.
- 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
- Model description
- patients
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Taha Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Taha Ibrahim, Tanta University
- Investigators
- Marwa T Ibrahim, lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987943
- Sponsor's protocol ID
- R-OS-9-22-6
- Status last verified
- Nov 2023
- First submitted
- 14 Jul 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Publications
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.
PubMed 38600501
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Oral and Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT05987943
- Acronym / sponsor ID
- R-OS-9-22-6
- Conditions
- Oroantral Fistula
- Keywords
- oroantral fistula, A Pedicled Buccal Periosteal Flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Marwa Taha IbrahimUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 7 Apr 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 14 Aug 2023 (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 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.
Detailed description
Background: 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.
Purpose: The aim of this prospective 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.
Patients \& Methods: Ten patients with oroantral fistula will be included in this study. The patients will be examined and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation: It will include the collection of demographic data, medical status and relevant history of the OAF (etiology, duration, resonance of voice, regurgitation of fluid, infection and previous surgical closure attempts). Cone beam computed tomography (CBCT) scan will be performed to determine the size of the underlying bony defect.
Surgical procedure: The buccal mucoperiosteal flap will be splitted horizontally into two layers: a deep periosteal layer and a superficial buccal mucosa layer. The fistula tract will transected at the bone level, the pedicled deep periosteal layer will be dissected and turned over the fistula at the bone level and will be stabilized using sutures. The superficial layer will be returned to its original position and sutured.
Postoperative evaluation: The patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation and recurrences.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients
| Arm | Type | Receives |
|---|---|---|
| healing.recurrence of oroanral fistula | Other | Procedure: A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral FistulaA Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients have oroantral fistula
- clear maxillary sinus with no infection
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral FistulaA Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula | Procedure or surgery | healing.recurrence of oroanral fistula |
Primary outcome
visual analogue scale
Time frame: 1 month
0 representing no pain and 10 representing the highest level of pain
comparison of vestibular depth preoperatively and postoperatively
Time frame: 1 month
the vestibular depth measured from gingival margin to bottom of vestibule.
inflammation score scale
Time frame: 1 month
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
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 21 Nov 2023.
- Derived from this study: PubMed 38600501Ibrahim 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.
- Individual participant dataSharing planned: No. A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula
Related trials for Oroantral Fistula
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Enrolling by invitation
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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.
Marwa T Ibrahim, lecturer principal investigator
Tanta 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 A Pedicled Buccal Periosteal Flap for the Closure of Oro-antral Fistula in people with Oroantral Fistula, run by Marwa Taha Ibrahim 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 2 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 21 Nov 2023. 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?
visual analogue scale (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT05987943, 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 21 Nov 2023.