Department of Stomatology - Hôpital NOVO Pontoise site
Pontoise, 95300, France
NCT Number: NCT05910073
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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Notify Me18 year and older
All sexes
Observational
Pontoise, 95300, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of a Lamina Curved plate (Osteobiol® Laboratory) in the treatment of OAC
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.
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
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
Hôpital NOVO
Other
Acronym: CBSL
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