NCT07476664

Acute Oroantral Communication Closure: Resorbable Collagen Membrane vs. Buccal Advancement Flap Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oroantral communication (OAC) is an abnormal opening between the oral cavity and the maxillary sinus that may occur after extraction of posterior maxillary teeth. If not treated promptly, it can lead to sinus contamination, chronic infection, and development of an oroantral fistula requiring more complex surgical management. The standard surgical treatment is closure with a buccal advancement flap (Rehrmann technique). However, this method may reduce vestibular depth, displace the mucogingival junction, and decrease the width of keratinized gingiva. This prospective clinical study compares two surgical approaches for closure of acute OAC diagnosed within 24 hours after tooth extraction: placement of a resorbable collagen membrane beneath the mucosa versus the conventional buccal advancement flap. Clinical and radiographic parameters related to soft tissue architecture, postoperative recovery, and bone healing are evaluated during a 90-day follow-up period.

Detailed description

Oroantral communication (OAC) is a pathological connection between the oral cavity and the maxillary sinus most commonly occurring after extraction of posterior maxillary teeth. The close anatomical relationship between the sinus floor and the roots of maxillary molars and premolars increases the risk of perforation of the Schneiderian membrane during dental extraction. If an OAC is not diagnosed and treated promptly, microbial contamination of the sinus may occur, potentially resulting in chronic maxillary sinusitis and epithelialization of the tract with formation of an oroantral fistula. Early closure of acute defects within 24-48 hours is therefore generally recommended. The buccal advancement flap described by Rehrmann is the most frequently used surgical technique for closure of acute OAC because of its technical simplicity and predictable closure of the defect. Nevertheless, advancement of the buccal mucoperiosteal flap may alter local soft tissue anatomy, including reduction of vestibular depth, displacement of the mucogingival junction, and loss of keratinized gingiva. These anatomical changes may affect oral hygiene and may complicate future prosthetic or implant therapy. Biomaterial-based techniques that preserve soft tissue architecture represent a potential alternative approach. Resorbable collagen membranes are widely used in guided tissue regeneration and guided bone regeneration due to their biocompatibility, clot stabilization properties, and barrier function. Heterologous collagen membranes, such as Creos Xenoprotect, are designed to integrate with surrounding tissues and gradually resorb without the need for surgical removal. Their use for closure of acute OAC has been described in clinical reports; however, comparative clinical data against conventional flap techniques remain limited. The present study is designed as a prospective, non-randomized comparative clinical investigation evaluating two surgical methods for closure of acute oroantral communications diagnosed within 24 hours after extraction of posterior maxillary teeth. Adult patients presenting with clinically and radiographically confirmed OAC are screened for eligibility and allocated to treatment according to the predefined clinical protocol. In the experimental group, closure of the communication is performed using a resorbable heterogeneous collagen membrane (Creos Xenoprotect) placed in a submucosal position to cover the defect. Limited mucoperiosteal elevation is performed as necessary, and the membrane is stabilized using sutures to achieve tension-free closure. In the control group, closure is performed using the conventional Rehrmann buccal advancement flap. After preparation of the extraction socket, a trapezoidal mucoperiosteal flap with vertical releasing incisions is elevated, mobilized using periosteal releasing incisions, and advanced coronally to achieve primary closure of the defect. The size of the oroantral communication is measured clinically using a calibrated periodontal probe and confirmed with limited-field cone-beam computed tomography (CBCT). Standardized perioperative management is applied in both groups, including socket debridement, smoothing of bony margins, sinus precautions, and scheduled postoperative follow-up.

Conditions

• Oroantral Communication
• Acute Oroantral Communication
• Oroantral Fistula
• Post-extraction Maxillary Sinus Communication

Interventions

Type	Name	Description
PROCEDURE	Resorbable collagen membrane OAC closure	Minimally invasive closure of acute oroantral communication using a resorbable heterogeneous collagen membrane placed in a submucosal position. After extraction socket debridement and smoothing of sharp bony margins, the membrane was trimmed to overlap the defect and inserted beneath the mucosa to fully cover the communication. Limited mucoperiosteal elevation was performed without vertical releasing incisions. The membrane was stabilized using horizontal mattress sutures to achieve tension-free coverage and was left to integrate and resorb spontaneously. Standardized postoperative antibiotics, sinus precautions, and follow-up visits were applied.
PROCEDURE	Buccal advancement flap OAC closure	Conventional surgical closure of acute oroantral communication using a coronally advanced buccal mucoperiosteal flap. Following socket debridement and smoothing of bony margins, a trapezoidal full-thickness flap with vertical releasing incisions was elevated. Periosteal releasing incisions were performed to allow tension-free coronal advancement of the flap over the defect. Primary closure was achieved with interrupted sutures. Postoperative management, including antibiotics, sinus precautions, and scheduled follow-up, was standardized across study groups.

Timeline

• Start date: 2021-05-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: Poland