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Completed

NCT Number: NCT05910073

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Stomatology - Hôpital NOVO Pontoise site

Pontoise, 95300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lamina curved plate

Device

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

Primary outcomes

  1. Efficacy assessment of Lamina Curved Plate in Managing Oroantral Communication

    Time frame: At the end of the study, an average of one month

    Number of patients with clinical closure of the OAC at D30 after the operation.

Secondary outcomes

  1. Assessment of the complication rate

    Time frame: At the end of the study, an average of one month

    The complication rate of the technique will be evaluated by the number of patients having had at least one complication from D7 post-op to D30 post-op out of the number of patients included

  2. Assessment of the rate of suture disunion

    Time frame: At the end of the study, an average of one month

    The rate of suture disunion will be assessed by the number of patients with at least one suture disunion from postoperative day 7 to postoperative day 30 out of the number of patients included

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: CBSL

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2023
Registry last updated
Sep 19, 2024

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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