Inverted Periosteal Flap vs Buccal Advancement Flap for Oroantral Communication Closure

NCT07630701 | Completed

• 1 other identifier: DN-230426-776
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oroantral Communication

Keywords

Inverted buccal periosteal flap; Buccal advancement flap; Oral and maxillofacial surgery; Maxillary sinus; Surgical closure

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Postoperative Pain

  Postoperative days 1, 3, 5, and 7.

• Postoperative Facial Edema

  Postoperative days 1, 3, and 5.

Study Arms (2)

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.

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.

Procedure: Buccal Advancement Flap

Interventions

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.

Inverted Buccal Periosteal Flap

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.

Buccal Advancement Flap

Eligibility Criteria

• Age: 24 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arab International University: lead
• Damascus University: collaborator

Study Sites (1)

School of Dental Medicine

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 20227153 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.

  PMID: 30931487 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.

  PMID: 17448851 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.

  PMID: 24768423 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.

  PMID: 38600501 BACKGROUND

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

Oral Fistula; Mouth Diseases; Stomatognathic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: September 15, 2024
• Primary Completion: August 8, 2025
• Study Completion: December 10, 2025
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)