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

NCT07476664 | Completed

• 1 other identifier: PCN/0022/KB1/94/20/21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

oroantral communication; acute OAC; buccal advancement flap; Rehrmann flap; oral surgery; CBCT bone density; vestibular depth preservation

Outcome Measures

Primary Outcomes (1)

• Change in vestibular depth from baseline to 90 days

  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.

  Baseline (day 0) to 90 days postoperatively

Secondary Outcomes (4)

• Change in keratinized gingiva width

  Baseline (day 0) to 90 days postoperatively

• Change in alveolar socket width

  Baseline (day 0) to 90 days postoperatively

• Postoperative pain intensity (VAS)

  Postoperative days 1, 7, and 14

• Incidence of postoperative complications

  Up to 90 days postoperatively

Study Arms (2)

Resorbable Collagen Membrane Closure

EXPERIMENTAL

Participants with acute oroantral communication diagnosed within 24 hours after extraction underwent minimally invasive closure using a resorbable heterogeneous collagen membrane (Creos Xenoprotect). After socket debridement and smoothing of sharp bony margins, the membrane was trimmed and inserted in a submucosal position to fully cover the defect. Limited mucoperiosteal elevation was performed without vertical releasing incisions. The membrane was stabilized with horizontal mattress sutures and allowed to integrate and resorb spontaneously. Standardized postoperative care, antibiotics, and follow-up were provided.

Procedure: Resorbable collagen membrane OAC closure

Buccal Advancement Flap (Rehrmann)

ACTIVE COMPARATOR

Participants with acute oroantral communication diagnosed within 24 hours after extraction underwent closure using the conventional Rehrmann buccal advancement flap. Following socket debridement and smoothing of bony margins, a trapezoidal full-thickness mucoperiosteal flap with vertical releasing incisions was elevated, mobilized with periosteal releasing incisions, and advanced coronally to achieve tension-free primary closure. Standardized postoperative care, antibiotics, and follow-up identical to the experimental arm were applied.

Procedure: Buccal advancement flap OAC closure

Interventions

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.

Also known as: Creos Xenoprotect, Collagen membrane closure, Submucosal membrane technique

Resorbable Collagen Membrane Closure

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.

Also known as: Rehrmann flap, Rehrmann technique, Buccal advancement flap

Buccal Advancement Flap (Rehrmann)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

University Dental Clinic of the Silesian Medical University in Katowice

Bytom, Poland

Location

MeSH Terms

Conditions

Oroantral Fistula

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative clinical measurements were performed by an independent calibrated examiner who was not involved in the surgical procedures. Radiographic density and linear measurements were conducted by trained investigators using standardized protocols. Participants and treating surgeon were not masked due to the nature of the surgical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a prospective, non-randomized, parallel-group clinical study comparing two surgical techniques for acute oroantral communication closure. Eligible adult patients diagnosed within 24 hours after maxillary posterior tooth extraction were allocated to either submucosal placement of a resorbable collagen membrane or closure using the Rehrmann buccal advancement flap. All procedures were performed by the same experienced oral surgeon using standardized perioperative protocols. Clinical and radiographic outcomes were evaluated over a 90-day follow-up period.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 17, 2026
• Study Start: May 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)