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| Name | Class |
|---|---|
| Damascus University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inverted Buccal Periosteal Flap | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week, 15 days, and 45 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative days 1, 3, 5, and 7. |
| Postoperative Facial Edema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Majd S Mohammad, DDs | Damascus University | Principal Investigator |
| Omar A Heshmeh, PhD | Damascus University | Study Chair |
| Saleh Al Kurdi, PhD | Arab International University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine | Damascus | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20227153 | Background | 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. | |
| 30931487 | Background | Parvini 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. |
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| ID | Term |
|---|---|
| D009957 | Oroantral Fistula |
| ID | Term |
|---|---|
| D016155 | Oral Fistula |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005402 | Fistula |
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| Buccal Advancement Flap | Procedure | 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. |
|
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. |
| Postoperative days 1, 3, and 5. |
| 17448851 | Background | Lago-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. |
| 24768423 | Background | Rosenfeld 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. |
| 38600501 | Background | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |