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

H

Hôpital NOVO

Status

Completed

Conditions

Oroantral Fistula

Treatments

Device: Lamina curved plate

Study type

Observational

Funder types

Other

Identifiers

NCT05910073
CHRD0623

Details and patient eligibility

About

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.

Full description

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria :

  • Follow-up less than 1 month after surgery
  • Patient under guardianship

Trial design

33 participants in 1 patient group

Lamina curved plate
Description:
Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC
Treatment:
Device: Lamina curved plate

Trial contacts and locations

1

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Central trial contact

Veronique Da Costa; Maryline Delattre

Data sourced from clinicaltrials.gov

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