Oroantral FistulaNCT06066086
A Hinge Flap to Reinforce Buccal Advancement Flap
A study testing A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla and An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla in people with Oroantral Fistula, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oroantral Fistula
- What is being tested?
- A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla and An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2023to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic oroantral fistula at the most posterior area of the maxilla
- Ages above 18 years
- Patients who are medical free
Who cannot join
- Oroantral communications
- Absence of sinus infection
- Oroantral fistula which are resulted from tumor resections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
College of Dentistry, Qassim University
Buraidah, Al-Qassim Region, 1162
Dean office, 0555052922 ext. +966, dean.office@qudent.org
About this study
Official title: A Hinge Flap as an Additional Layer to Reinforce the Buccal Advancement Flap for Treating Chronic Oroantral Fistulae (COAF) in the Most Posterior Aspect of the Maxilla"
Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. The use of palatal flaps has been documented for treating such fistulae. The presence of the oroantral fistula at the area of second molars or maxillary tuberosity could complicate the use of the palatal rotational flap where the arch of its rotation is increased leading to compromised blood supply. The use of the buccal flap is not advocated because it is very thin.
Rationale Double or triple-layer closure is indicated to avoid recurrence of the COAF. Different layers have been documented to minimize the risk of recurrence and reinforce buccal flaps. The oral tissues at the oral side of the oroantral fistula could used as an additional layer with buccal advancement flap and buccal fat to omit the use of palatal flap with its subsequent problems in the most posterior aspect of the maxilla Study objectives Therefore, this study will be conducted to evaluate the use of hinge flaps to reinforce the buccal advancement flap for surgical closure of the COAF in the most posterior area of the maxilla
Methods The hinge flap will be performed at the oral side of the COAF to close the perforation in the sinus membrane. The oral side of the COAF will be closed with buccal advancement flap. The success rate, recurrence, time of surgery, postoperative complications, will be evaluated.
Read the detailed description
Background:
The surgical therapy of COAF is one of the most challenging subjects. Local flaps are usually performed to close oroantral fistula (OAF). Each flap has advantages and limitations; none is superior to others. The appropriate flap is determined by the location and size of OAF, prosthetic therapy, and the surgeon's skill.5 Buccal advancement flaps, palatal rotational flaps, and buccal fat pad (BFP) are the most commonly employed local flaps, either alone or in combination. Although buccal flap surgery is easy, it is not recommended for large, COAFs because it is very thin, has poor perfusion, and is prone to strain due to lip and check muscle movements, making it more prone to rupture and tear.The palatal rotational flap is preferred in such instances, however, it has significant technical challenges, such as bunching the flap along its axis of rotation and kinking the greater palatine artery. If the OAFs are in the most posterior area of the maxilla, particularly towards the second and third molars, flap rotation may jeopardize the vascular pedicle, resulting in closure failure. So, many authors supported the use of BFP to add strength to the buccal flap, but it also has significant drawbacks.6 First, the BFP can be perforated and detached from its blood supply while being dissected from its surrounding components, resulting in necrosis. Furthermore, in certain instances, the size of the BFP may be insufficient to cover the OAF.
Rationale A prospective study will be enrolled to evaluate the use of the hinge flap to reinforce the buccal advancement flap for the management of COAFs in the most posterior area of the maxilla. The second aim of the study was to implement an algorithm for the management of OAFs based on the authors' 20 years of experience in the management of OAFs.
Methods A double-blinded randomized control trial will be conducted. Patients were divided into two groups: hinge flap or palatal flap. The palatal flap group will be served as the control group, while the hinge flap will be the tested group.The patient sequences will be used for randomization. Patients with even numbers will be assigned to the hinge flap group, while those with odd numbers will be assigned to the palatal flap group. The following steps will be taken to achieve blindness: 1) The patients and evaluators who will interview them to measure the study's variables will not informed about the study and 2) The investigators who will review the questionnaires and the statistician who will analyze the study's results will know the study's groups as A and B.
- Conditions
- Oroantral Fistula
- Being tested
- A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla, An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla
- Keywords
- Chronic Oroantral Fistula
- 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 hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxillaProcedure or surgery
The hinge flap is raised via circular incision around the oral side of the oroantral fistula then sutured with purse suture to close the sinus membrane perforation and it is used as an additional layer that reinforce the buccal advancement flap
An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxillaProcedure or surgery
Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues.
| Study group | Role | What they receive |
|---|---|---|
| Hinge Flap group | Experimental | Patients who will be included in this study will be treated by using hinge flap and buccal advancement flap to close their oroantral fistula. A circular incision will be performed at the oral side of the oroantral fistula. The tissues will be reflected and sutured by purse sutures. Then the tissues will be pushed up to close sinus membrane. A pyramidal flap will be reflected at the buccal tissues, then horizontal incisions will be performed at the base of the flap to allow advancement of the flap over the fistula and a tension-free suturing to the palatal tissues. Receives: Procedure: A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla |
| Palatal Flap group | Active comparator | Patients who will be included in this study will be treated by using he anteriorly based palatal rotational flap to close the oroantral fistula. Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues. Receives: Procedure: An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Surgery
The time elapsed from the initial incision to final closure of the flap. The time will be calculated in minutes. The mean and standard deviation will be then calculated and used to compare between the study's arms.A prolonged time means worse outcomes
Measured: 30 minutes
Difficulties during surgeries
Surgical difficulties scoring system will be used.Surgical difficulty was assessed by the operator using an index of 1-10 with the following divisions: 1-3 low difficulty, 4-6 intermediate difficulty, and 7-10 high difficulty. A low difficulty score means a better outcome
Measured: 60 minutes
Recurrence of the Oroantral fistula
The patients will be followed after surgery for the success or failure of the surgical closure. The follow-up will be weekly in the first month, and then monthly in the next three months.The recurrence means worse outcomes
Measured: At the end of the postoperative fourth month
Secondary outcomes (1)
Patients' satisfaction
A patient satisfaction survey is a set of questions used to collect feedback from patients to measure their satisfaction with the quality and care of the healthcare service provider.Based on their responses, patients will be divided into three categories: Promoters (9-10), Passives (7-8), and Detractors (0-6).
Measured: At the end of the fourth month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Amin Khalifa, PhD, Qassim University
- Investigators
- Ghada A khalifa, Professor, Study director, Department of Maxillofacial Study and Diagnostic Sciences, College of Dentistry, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066086
- Sponsor's protocol ID
- ID: 23-24-14
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hinge Flap as an Additional Layer to Reinforce the Buccal Advancement Flap for Treating Chronic Oroantral Fistulae (COAF) in the Most Posterior Aspect of the Maxilla"
- ClinicalTrials.gov ID
- NCT06066086
- Acronym / sponsor ID
- ID: 23-24-14
- Conditions
- Oroantral Fistula
- Keywords
- Chronic Oroantral Fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Oct 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.
Background The chronic oroantral fistulas (COAF) is an epithelized communication that is formed between the squamous epithelium of the oral cavity and the pseudo-stratified columnar ciliated epithelium of the maxillary sinus with a high recurrent rate. The use of palatal flaps has been documented for treating such fistulae. The presence of the oroantral fistula at the area of second molars or maxillary tuberosity could complicate the use of the palatal rotational flap where the arch of its rotation is increased leading to compromised blood supply. The use of the buccal flap is not advocated because it is very thin.
Rationale Double or triple-layer closure is indicated to avoid recurrence of the COAF. Different layers have been documented to minimize the risk of recurrence and reinforce buccal flaps. The oral tissues at the oral side of the oroantral fistula could used as an additional layer with buccal advancement flap and buccal fat to omit the use of palatal flap with its subsequent problems in the most posterior aspect of the maxilla Study objectives Therefore, this study will be conducted to evaluate the use of hinge flaps to reinforce the buccal advancement flap for surgical closure of the COAF in the most posterior area of the maxilla
Methods The hinge flap will be performed at the oral side of the COAF to close the perforation in the sinus membrane. The oral side of the COAF will be closed with buccal advancement flap. The success rate, recurrence, time of surgery, postoperative complications, will be evaluated.
Detailed description
Background:
The surgical therapy of COAF is one of the most challenging subjects. Local flaps are usually performed to close oroantral fistula (OAF). Each flap has advantages and limitations; none is superior to others. The appropriate flap is determined by the location and size of OAF, prosthetic therapy, and the surgeon's skill.5 Buccal advancement flaps, palatal rotational flaps, and buccal fat pad (BFP) are the most commonly employed local flaps, either alone or in combination. Although buccal flap surgery is easy, it is not recommended for large, COAFs because it is very thin, has poor perfusion, and is prone to strain due to lip and check muscle movements, making it more prone to rupture and tear.The palatal rotational flap is preferred in such instances, however, it has significant technical challenges, such as bunching the flap along its axis of rotation and kinking the greater palatine artery. If the OAFs are in the most posterior area of the maxilla, particularly towards the second and third molars, flap rotation may jeopardize the vascular pedicle, resulting in closure failure. So, many authors supported the use of BFP to add strength to the buccal flap, but it also has significant drawbacks.6 First, the BFP can be perforated and detached from its blood supply while being dissected from its surrounding components, resulting in necrosis. Furthermore, in certain instances, the size of the BFP may be insufficient to cover the OAF.
Rationale A prospective study will be enrolled to evaluate the use of the hinge flap to reinforce the buccal advancement flap for the management of COAFs in the most posterior area of the maxilla. The second aim of the study was to implement an algorithm for the management of OAFs based on the authors' 20 years of experience in the management of OAFs.
Methods A double-blinded randomized control trial will be conducted. Patients were divided into two groups: hinge flap or palatal flap. The palatal flap group will be served as the control group, while the hinge flap will be the tested group.The patient sequences will be used for randomization. Patients with even numbers will be assigned to the hinge flap group, while those with odd numbers will be assigned to the palatal flap group. The following steps will be taken to achieve blindness: 1) The patients and evaluators who will interview them to measure the study's variables will not informed about the study and 2) The investigators who will review the questionnaires and the statistician who will analyze the study's results will know the study's groups as A and B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hinge Flap group | Experimental | Procedure: A hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxillaPatients who will be included in this study will be treated by using hinge flap and buccal advancement flap to close their oroantral fistula. A circular incision will be performed at the oral side of the oroantral fistula. The tissues will be reflected and sutured by purse sutures. Then the tissues will be pushed up to close sinus membrane. A pyramidal flap will be reflected at the buccal tissues, then horizontal incisions will be performed at the base of the flap to allow advancement of the flap over the fistula and a tension-free suturing to the palatal tissues. |
| Palatal Flap group | Active comparator | Procedure: An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxillaPatients who will be included in this study will be treated by using he anteriorly based palatal rotational flap to close the oroantral fistula. Two paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic oroantral fistula at the most posterior area of the maxilla
- Ages above 18 years
- Patients who are medical free
Key exclusion criteria (3 listed)
- Oroantral communications
- Absence of sinus infection
- Oroantral fistula which are resulted from tumor resections
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 hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxillaThe hinge flap is raised via circular incision around the oral side of the oroantral fistula then sutured with purse suture to close the sinus membrane perforation and it is used as an additional layer that reinforce the buccal advancement flap | Procedure or surgery | Hinge Flap group |
| An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxillaTwo paralleling incisions will be performed on the palatal side of the fistula. The distance between the two incisions will be 2 to 3 mm greater than the width of the fistula. Then the two incisions will be connected together via a circular incision at the bony end of the hard palate. The flap reflection will be performed, and the greater palatine vessels will be legated and cauterized to allow lateral repositioning of the flap over the fistula. The flap will be sutured to the buccal tissues. | Procedure or surgery | Palatal Flap group |
Primary outcome
Duration of Surgery
Time frame: 30 minutes
The time elapsed from the initial incision to final closure of the flap. The time will be calculated in minutes. The mean and standard deviation will be then calculated and used to compare between the study's arms.A prolonged time means worse outcomes
Difficulties during surgeries
Time frame: 60 minutes
Surgical difficulties scoring system will be used.Surgical difficulty was assessed by the operator using an index of 1-10 with the following divisions: 1-3 low difficulty, 4-6 intermediate difficulty, and 7-10 high difficulty. A low difficulty score means a better outcome
Recurrence of the Oroantral fistula
Time frame: At the end of the postoperative fourth month
The patients will be followed after surgery for the success or failure of the surgical closure. The follow-up will be weekly in the first month, and then monthly in the next three months.The recurrence means worse outcomes
1 secondary outcome
Patients' satisfaction
Time frame: At the end of the fourth month after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- 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.
Ghada A khalifa, Professor study director
Department of Maxillofacial Study and Diagnostic Sciences, College of Dentistry, Qassim 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 hinge flap will be performed to reinforce the buccal advancement flap to close the oroantral fistula at the most posterior area of the maxilla and An anteriorly based palatal flap will be performed to close the oroantral fistula at the most posterior area of the maxilla in people with Oroantral Fistula, run by Qassim University at 1 site in Saudi Arabia.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada A Khalifa, Professor (0096504840248, G.Khalifa@qudent.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Surgery (time frame: 30 minutes). 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?
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 9 Jun 2026.