Oroantral CommunicationNCT07630701
Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure
A study testing Inverted Buccal Periosteal Flap and Buccal Advancement Flap in people with Oroantral Communication, run by Arab International University at 1 site in Syria.
Trial summary
This randomized controlled clinical study will evaluate the effectiveness of the inverted buccal periosteal flap in closing recent post-extraction oroantral communications and compare it with the conventional buccal advancement flap. Read more about this study
- Who is it for?
- Ages 24 to 50 years
- Conditions the study is for
- Oroantral Communication
- What is being tested?
- Inverted Buccal Periosteal Flap and Buccal Advancement Flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSyria
- Study dates
- 15 Sep 2024to 10 Dec 2025
- 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 24 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of an oroantral communication (OAC) with a diameter between 3-7 mm.
- Communication resulting from extraction of posterior maxillary teeth (first molar, second molar, third molar, or second premolar).
- Recent perforation occurring no more than 48 hours prior to surgical intervention.
Who cannot join
- Presence of foreign bodies or residual tooth fragments within the maxillary sinus.
- Presence of systemic diseases that could impair wound healing (e.g., uncontrolled diabetes, immunosuppression).
- History of maxillary sinusitis prior to the perforation.
- Presence of periapical lesions or cysts at the extraction site.
- Smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Inverted Periosteal Flap Versus Buccal Advancement Flap for Closure of Post-Extraction Maxillary Sinus Perforation: A Randomized Controlled Trial
This randomized controlled clinical study will evaluate the effectiveness of the inverted buccal periosteal flap in closing recent post-extraction oroantral communications and compare it with the conventional buccal advancement flap. The study will include 24 patients who develop an oroantral communication measuring 3-6 mm after non-surgical extraction of maxillary posterior teeth. Participants will be randomly allocated into two groups: the test group treated with the inverted buccal periosteal flap, and the control group treated with the buccal advancement flap. The primary outcome will be successful clinical closure of the communication, assessed by absence of oroantral fistula, nasal fluid leakage, and air leakage during the Valsalva test. Secondary outcomes will include postoperative pain, facial edema. Patients will be followed for up to 45 days after surgery.
Read the detailed description
Oroantral communication is an abnormal connection between the oral cavity and the maxillary sinus, most commonly occurring after extraction of maxillary posterior teeth. If not closed properly, it may lead to oroantral fistula or maxillary sinus complications.
This randomized controlled clinical study will compare the inverted buccal periosteal flap with the conventional buccal advancement flap for closure of recent post-extraction oroantral communications. The study will include 24 patients with communications measuring 3-6 mm and diagnosed within 48 hours after non-surgical extraction.
Participants will be randomly divided into two groups. In the test group, closure will be performed using the inverted buccal periosteal flap, where the periosteal layer is dissected, inverted over the defect, and sutured to the palatal tissue without tension. In the control group, closure will be performed using the buccal advancement flap, where a buccal mucoperiosteal flap is advanced palatally and sutured to cover the communication.
- Conditions
- Oroantral Communication
- Being tested
- Inverted Buccal Periosteal Flap, Buccal Advancement Flap
- Keywords
- Inverted buccal periosteal flap, Buccal advancement flap, Oral and maxillofacial surgery, Maxillary sinus, Surgical closure
- Medical subject headings
- Oroantral Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted Buccal Periosteal FlapProcedure or surgery
Surgical closure of post-extraction oroantral communication using an inverted buccal periosteal flap. A full-thickness mucoperiosteal flap will be elevated, followed by dissection of the periosteal layer from the overlying mucosa. The periosteal flap will then be inverted over the defect and sutured to the palatal tissue to achieve tension-free closure.
Buccal Advancement FlapProcedure or surgery
Surgical closure of post-extraction oroantral communication using the conventional buccal advancement flap. A buccal full-thickness mucoperiosteal flap will be elevated, released by periosteal scoring, advanced palatally, and sutured to the palatal mucosa to cover the communication.
| Study group | Role | What they receive |
|---|---|---|
| Inverted Buccal Periosteal Flap | Experimental | Participants in this arm will receive surgical closure of the post-extraction oroantral communication using the inverted buccal periosteal flap. A full-thickness mucoperiosteal flap will be elevated, the periosteal layer will be dissected and inverted over the defect, then sutured to the palatal tissue to achieve tension-free closure. Receives: Procedure: Inverted Buccal Periosteal Flap |
| Buccal Advancement Flap | Active comparator | Participants in this arm will receive surgical closure of the post-extraction oroantral communication using the conventional buccal advancement flap. A buccal mucoperiosteal flap will be elevated, advanced palatally, and sutured to the palatal mucosa to cover the communication. Receives: Procedure: Buccal Advancement Flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Closure of Oroantral Communication
Successful closure will be assessed clinically by confirming the absence of oroantral fistula formation, absence of fluid leakage through the nose, and absence of air leakage or air bubbles during the Valsalva test.
Measured: 1 week, 15 days, and 45 days after surgery.
Secondary outcomes (2)
Postoperative Pain
Postoperative pain will be assessed using the Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate a worse outcome.
Measured: Postoperative days 1, 3, 5, and 7.
Postoperative Facial Edema
Facial edema will be assessed using extraoral linear measurements between fixed facial reference points. The measured distances will be used to estimate postoperative facial swelling and compare changes between the two study groups. Higher values indicate greater facial edema and therefore a worse outcome.
Measured: Postoperative days 1, 3, and 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start15 Sep 2024
- Primary completion8 Aug 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Oroantral CommunicationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab International University
- Sponsor type
- University, hospital or other
- Collaborators
- Damascus University
- Responsible party
- Sponsor
- Investigators
- Majd S Mohammad, DDs, Principal investigator, Damascus UniversityOmar A Heshmeh, PhD, Study chair, Damascus UniversitySaleh Al Kurdi, PhD, Study director, Arab International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630701
- Sponsor's protocol ID
- DN-230426-776
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visscher SH, van Minnen B, Bos RR. Closure of oroantral communications: a review of the literature. J Oral Maxillofac Surg. 2010 Jun;68(6):1384-91. doi: 10.1016/j.joms.2009.07.044. Epub 2010 Mar 12. No abstract available.
PubMed 20227153Parvini P, Obreja K, Begic A, Schwarz F, Becker J, Sader R, Salti L. Decision-making in closure of oroantral communication and fistula. Int J Implant Dent. 2019 Apr 1;5(1):13. doi: 10.1186/s40729-019-0165-7.
PubMed 30931487Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gandara Rey JM, Garcia-Garcia A. Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007 May;65(5):979-83. doi: 10.1016/j.joms.2006.06.281.
PubMed 17448851Rosenfeld EA. Inverted periosteal flap: an alternative to the buccal advancement flap for tension-free, watertight closure. J Oral Maxillofac Surg. 2014 Jul;72(7):1244-50. doi: 10.1016/j.joms.2014.03.006. Epub 2014 Mar 20.
PubMed 24768423Ibrahim 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inverted Periosteal Flap Versus Buccal Advancement Flap for Closure of Post-Extraction Maxillary Sinus Perforation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07630701
- Acronym / sponsor ID
- DN-230426-776
- Conditions
- Oroantral Communication
- Keywords
- Inverted buccal periosteal flap, Buccal advancement flap, Oral and maxillofacial surgery, Maxillary sinus, Surgical closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Arab International UniversityUniversity, hospital or other
- Collaborators
- Damascus University
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 5 Jun 2026 (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.
This randomized controlled clinical study will evaluate the effectiveness of the inverted buccal periosteal flap in closing recent post-extraction oroantral communications and compare it with the conventional buccal advancement flap. The study will include 24 patients who develop an oroantral communication measuring 3-6 mm after non-surgical extraction of maxillary posterior teeth. Participants will be randomly allocated into two groups: the test group treated with the inverted buccal periosteal flap, and the control group treated with the buccal advancement flap. The primary outcome will be successful clinical closure of the communication, assessed by absence of oroantral fistula, nasal fluid leakage, and air leakage during the Valsalva test. Secondary outcomes will include postoperative pain, facial edema. Patients will be followed for up to 45 days after surgery.
Detailed description
Oroantral communication is an abnormal connection between the oral cavity and the maxillary sinus, most commonly occurring after extraction of maxillary posterior teeth. If not closed properly, it may lead to oroantral fistula or maxillary sinus complications.
This randomized controlled clinical study will compare the inverted buccal periosteal flap with the conventional buccal advancement flap for closure of recent post-extraction oroantral communications. The study will include 24 patients with communications measuring 3-6 mm and diagnosed within 48 hours after non-surgical extraction.
Participants will be randomly divided into two groups. In the test group, closure will be performed using the inverted buccal periosteal flap, where the periosteal layer is dissected, inverted over the defect, and sutured to the palatal tissue without tension. In the control group, closure will be performed using the buccal advancement flap, where a buccal mucoperiosteal flap is advanced palatally and sutured to cover the communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inverted Buccal Periosteal Flap | Experimental | Procedure: Inverted Buccal Periosteal FlapParticipants in this arm will receive surgical closure of the post-extraction oroantral communication using the inverted buccal periosteal flap. A full-thickness mucoperiosteal flap will be elevated, the periosteal layer will be dissected and inverted over the defect, then sutured to the palatal tissue to achieve tension-free closure. |
| Buccal Advancement Flap | Active comparator | Procedure: Buccal Advancement FlapParticipants in this arm will receive surgical closure of the post-extraction oroantral communication using the conventional buccal advancement flap. A buccal mucoperiosteal flap will be elevated, advanced palatally, and sutured to the palatal mucosa to cover the communication. |
Who may qualify
- Ages
- 24 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of an oroantral communication (OAC) with a diameter between 3-7 mm.
- Communication resulting from extraction of posterior maxillary teeth (first molar, second molar, third molar, or second premolar).
- Recent perforation occurring no more than 48 hours prior to surgical intervention.
Key exclusion criteria (5 listed)
- Presence of foreign bodies or residual tooth fragments within the maxillary sinus.
- Presence of systemic diseases that could impair wound healing (e.g., uncontrolled diabetes, immunosuppression).
- History of maxillary sinusitis prior to the perforation.
- Presence of periapical lesions or cysts at the extraction site.
- Smokers.
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 |
|---|---|---|
| Inverted Buccal Periosteal FlapSurgical closure of post-extraction oroantral communication using an inverted buccal periosteal flap. A full-thickness mucoperiosteal flap will be elevated, followed by dissection of the periosteal layer from the overlying mucosa. The periosteal flap will then be inverted over the defect and sutured to the palatal tissue to achieve tension-free closure. | Procedure or surgery | Inverted Buccal Periosteal Flap |
| Buccal Advancement FlapSurgical closure of post-extraction oroantral communication using the conventional buccal advancement flap. A buccal full-thickness mucoperiosteal flap will be elevated, released by periosteal scoring, advanced palatally, and sutured to the palatal mucosa to cover the communication. | Procedure or surgery | Buccal Advancement Flap |
Primary outcome
Successful Closure of Oroantral Communication
Time frame: 1 week, 15 days, and 45 days after surgery.
Successful closure will be assessed clinically by confirming the absence of oroantral fistula formation, absence of fluid leakage through the nose, and absence of air leakage or air bubbles during the Valsalva test.
2 secondary outcomes
Postoperative Pain
Time frame: Postoperative days 1, 3, 5, and 7.
Postoperative Facial Edema
Time frame: Postoperative days 1, 3, and 5.
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 5 Jun 2026.
- Background: PubMed 20227153Visscher SH, van Minnen B, Bos RR. Closure of oroantral communications: a review of the literature. J Oral Maxillofac Surg. 2010 Jun;68(6):1384-91. doi: 10.1016/j.joms.2009.07.044. Epub 2010 Mar 12. No abstract available.
- Background: PubMed 30931487Parvini P, Obreja K, Begic A, Schwarz F, Becker J, Sader R, Salti L. Decision-making in closure of oroantral communication and fistula. Int J Implant Dent. 2019 Apr 1;5(1):13. doi: 10.1186/s40729-019-0165-7.
- Background: PubMed 17448851Lago-Mendez L, Diniz-Freitas M, Senra-Rivera C, Gude-Sampedro F, Gandara Rey JM, Garcia-Garcia A. Relationships between surgical difficulty and postoperative pain in lower third molar extractions. J Oral Maxillofac Surg. 2007 May;65(5):979-83. doi: 10.1016/j.joms.2006.06.281.
- Background: PubMed 24768423Rosenfeld EA. Inverted periosteal flap: an alternative to the buccal advancement flap for tension-free, watertight closure. J Oral Maxillofac Surg. 2014 Jul;72(7):1244-50. doi: 10.1016/j.joms.2014.03.006. Epub 2014 Mar 20.
- Background: 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
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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.
Majd S Mohammad, DDs principal investigator
Damascus University
Omar A Heshmeh, PhD study chair
Damascus University
Saleh Al Kurdi, PhD study director
Arab International 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 Inverted Buccal Periosteal Flap and Buccal Advancement Flap in people with Oroantral Communication, run by Arab International University at 1 site in Syria.
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 5 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 5 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 Syria. 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?
Successful Closure of Oroantral Communication (time frame: 1 week, 15 days, and 45 days after surgery.). 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 NCT07630701, which also lists 5 linked publications.
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 5 Jun 2026.