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临床试验/NCT07476664
NCT07476664已完成不适用

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

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Change in vestibular depth from baseline to 90 days

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Resorbable collagen membrane OAC closure (Procedure)

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.

干预措施: Buccal advancement flap OAC closure (Procedure)

结局指标

主要结局

Change in vestibular depth from baseline to 90 days

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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