Oro-Antral CommunicationNCT06044012
Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Oro-antral Fistula
A study testing Double layer of buccal myomucosal Flap and buccal pad of fat in people with Oro-Antral Communication, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oro-Antral Communication
- What is being tested?
- Double layer of buccal myomucosal Flap and buccal pad of fat
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Large Oro-antral Fistula
- Recent or previously failed closure of oro-antral Fistula
Who cannot join
- Immuno-supressed patients
- fistulae smaller than 5 mm in size
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Layer of Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Large Oro-antral Fistula
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.
- Conditions
- Oro-Antral Communication
- Being tested
- Double layer of buccal myomucosal Flap and buccal pad of fat
- Keywords
- Oro-Antral Fistula, Buccal pad of fat, Myomucosal 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.
Double layer of buccal myomucosal Flap and buccal pad of fatProcedure or surgery
The buccal myomucosal flap will be harvested from cheek below stenson papilla and will be sutured over buccal pad of fat which will be sutured at palatal mucosa after complete curettage of infected fistulous tract.
| Study group | Role | What they receive |
|---|---|---|
| Patients with large Oro-antral Fistula | Experimental | closure of oro-antral fistula by myomucosal flap and buccal pad of fat Receives: Procedure: Double layer of buccal myomucosal Flap and buccal pad of fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
The size of fistula will be clinically measured by digital caliper in centimeter for preoperative and postoperative for uneventful wound healing and disappearance of fistula .
Measured: 6 months
Secondary outcomes (1)
infection
fluid level will be measured in cubic centimeter in computed tomography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oro-Antral CommunicationStudies of the same condition, open and under way.
- More trials run by Tanta 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdellatif Abdelfatah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044012
- Sponsor's protocol ID
- #R-OS-1-23-3
- Status last verified
- Aug 2024
- First submitted
- 8 May 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Layer of Buccal Myomucosal Flap and Buccal Pad of Fat for the Closure of Large Oro-antral Fistula
- ClinicalTrials.gov ID
- NCT06044012
- Acronym / sponsor ID
- #R-OS-1-23-3
- Conditions
- Oro-Antral Communication
- Keywords
- Oro-Antral Fistula, Buccal pad of fat, Myomucosal Flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with large Oro-antral Fistula | Experimental | Procedure: Double layer of buccal myomucosal Flap and buccal pad of fatclosure of oro-antral fistula by myomucosal flap and buccal pad of fat |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Large Oro-antral Fistula
- Recent or previously failed closure of oro-antral Fistula
Key exclusion criteria (2 listed)
- Immuno-supressed patients
- fistulae smaller than 5 mm in size
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 |
|---|---|---|
| Double layer of buccal myomucosal Flap and buccal pad of fatThe buccal myomucosal flap will be harvested from cheek below stenson papilla and will be sutured over buccal pad of fat which will be sutured at palatal mucosa after complete curettage of infected fistulous tract. | Procedure or surgery | Patients with large Oro-antral Fistula |
Primary outcome
Healing
Time frame: 6 months
The size of fistula will be clinically measured by digital caliper in centimeter for preoperative and postoperative for uneventful wound healing and disappearance of fistula .
1 secondary outcome
infection
Time frame: 6 months
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 13 Aug 2024.
Related trials for Oro-Antral Communication
Not yet recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Recruiting
A Hinge Flap to Reinforce Buccal Advancement Flap
Oroantral Fistula
Enrolling by invitation
Allogenic Bone Block for Oro-Antral Communication Closure for Subsequent Implant Placement
Tooth Loss
Enrolling by invitation
Double-Layer Closure Technique Using Buccal and Palatal Flaps for Oroantral Fistula
Oroantral Fistula, Double Layer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double layer of buccal myomucosal Flap and buccal pad of fat in people with Oro-Antral Communication, run by Tanta 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 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 13 Aug 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?
Healing (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.