Efficacy Assessment of Lamina Curved Plate in Managing Oroantral Communication (OACs)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-16

Study Completion Date

2023-06-29

Brief Summary

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The aim of this study is to assess the success rate, of using a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of persistent OACs over 5mm.

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Detailed Description

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Oroantral communication (OAC) is an abnormal opening that forms between the maxillary sinus and oral cavity. This communication can occur as a result of tooth extraction, maxillofacial surgery or dental infections. Microorganisms from the oral cavity can then colonise the maxillary sinuses, leading to infections. Prompt and effective management of a OAC is essential to prevent complications such as acute or chronic sinusitis, facial pain or inflammation. Closure is usually made surgically with a local flap such as Fat pad flap, palatal or vestibular flap or with natural or synthetic biomaterials.

However, OACs may persist even after attempted closure, and there is also a risk of facial nerve damage during the dissection of the Bichat's flap.

All these factors prompt the evaluation of surgical procedures employed in the treatment of OACs, including the use of the Lamina Curved biomaterial from Osteobiol®. This biomaterial comprises a decalcified flexible plate made of heterologous cortical bone. It serves to reconstruct the sinus floor and isolate the sinus from the oral cavity. The plate is secured using osteosynthesis screws and possesses the characteristic of being resorbable.

The objective of this study is to investigate the success rate, of utilizing the Lamina Curved plate (Osteobiol® Laboratory) and to provide surgeons with an additional reference technique for treating OACs larger than 5mm.

Conditions

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Oroantral Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lamina curved plate

Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC

Lamina curved plate

Intervention Type DEVICE

Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC

Interventions

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Lamina curved plate

Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with persistent OAC greater than 5mm treated with the use of an Osteobiol® Lamina curved plate
* Age ≥ 18 years
* Patients informed of the study and who did not object.