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Completed

NCT Number: NCT07476664

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Dental Clinic of the Silesian Medical University in Katowice

Bytom, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years or older
  • Acute oroantral communication diagnosed within 24 hours after extraction of a maxillary posterior tooth
  • General health status permitting outpatient dental surgery
  • Indication for single-tooth extraction in the posterior maxilla
  • Systemic conditions not contraindicating minor oral surgery
  • Ability and willingness to attend scheduled follow-up visits
  • Provision of written informed consent

Exclusion criteria

  • Oroantral communication present for more than 24 hours
  • Chronic inflammatory disease of the maxillary sinus
  • History of head and neck neoplastic disease or its treatment
  • Pregnancy
  • Systemic diseases preventing outpatient surgical treatment
  • Blood disorders or coagulation abnormalities
  • Ongoing anticoagulant therapy
  • Immunosuppressive therapy
  • Age under 18 years
  • History of multiple previous surgical procedures in the study area

Treatment and study plan

Resorbable collagen membrane OAC closure

Procedure

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.

Other names: Creos Xenoprotect, Collagen membrane closure, Submucosal membrane technique

Buccal advancement flap OAC closure

Procedure

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.

Other names: Rehrmann flap, Rehrmann technique, Buccal advancement flap

Primary outcomes

  1. Change in vestibular depth from baseline to 90 days

    Time frame: Baseline (day 0) to 90 days postoperatively

    The primary outcome was the change in oral vestibular depth at the surgical site, measured in millimeters using a calibrated WHO periodontal probe. Measurements were obtained at baseline (day 0) and during follow-up visits. The endpoint reflects preservation of soft tissue architecture after oroantral communication closure. Greater preservation (smaller reduction from baseline) indicates a more favorable clinical outcome for future prosthetic or implant rehabilitation.

Secondary outcomes

  1. Change in keratinized gingiva width

    Time frame: Baseline (day 0) to 90 days postoperatively

    Width of keratinized gingiva at the surgical site measured in millimeters with a calibrated WHO periodontal probe at baseline and follow-up visits. The outcome assesses preservation of keratinized tissue after oroantral communication closure. Greater preservation indicates a more favorable soft tissue result for long-term oral hygiene and prosthetic planning.

  2. Change in alveolar socket width

    Time frame: Baseline (day 0) to 90 days postoperatively

    Buccopalatal width of the post-extraction alveolar socket measured clinically and radiographically at predefined time points. This parameter evaluates dimensional stability of the alveolar ridge following closure of oroantral communication. Smaller reduction from baseline indicates better preservation of ridge architecture.

  3. Postoperative pain intensity (VAS)

    Time frame: Postoperative days 1, 7, and 14

    Patient-reported pain assessed using a 100 mm Visual Analogue Scale (VAS), where 0 indicates no pain and 100 indicates worst imaginable pain. Patients marked their pain level at each follow-up visit. Lower scores indicate better postoperative comfort.

  4. Incidence of postoperative complications

    Time frame: Up to 90 days postoperatively

    Occurrence of adverse postoperative events including swelling, hematoma, epistaxis, wound dehiscence, persistent oroantral communication, fistula formation, or clinical signs of sinusitis. Events were recorded during scheduled follow-up visits.

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Acronym: AOC

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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