Clinical trial NCT05910073: Efficacy Assessment of Lamina Curved Plate in Managing Oroantral Communication (OACs)
Official title: Efficacy Assessment of Lamina Curved Plate in Managing Oroantral Communication (OACs)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oroantral Fistula
Keywords: Oroantral Fistula
Lamina Curved plate
Oral Surgery
Chronic sinusitis
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All major patients with persistent SBC greater than 5mm treated with an Osteobiol® Lamina curved plate.

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Efficacy assessment of Lamina Curved Plate in Managing Oroantral Communication
timeFrame: At the end of the study, an average of one month
Secondary outcomes:
measure: Assessment of the complication rate
timeFrame: At the end of the study, an average of one month
measure: Assessment of the rate of suture disunion
timeFrame: At the end of the study, an average of one month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Department of Stomatology - Hôpital NOVO Pontoise site
Study officials:
affiliation: Hôpital NOVO
name: Dr Nicolas Jaballah Magdeleine
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shahrour R, Shah P, Withana T, Jung J, Syed AZ. Oroantral communication, its causes, complications, treatments and radiographic features: A pictorial review. Imaging Sci Dent. 2021 Sep;51(3):307-311. doi: 10.5624/isd.20210035. Epub 2021 Jul 13.
citation: Scott P, Fabbroni G, Mitchell DA. The buccal fat pad in the closure of oro-antral communications: an illustrated guide. Dent Update. 2004 Jul-Aug;31(6):363-4, 366. doi: 10.12968/denu.2004.31.6.363.
citation: Lee JJ, Kok SH, Chang HH, Yang PJ, Hahn LJ, Kuo YS. Repair of oroantral communications in the third molar region by random palatal flap. Int J Oral Maxillofac Surg. 2002 Dec;31(6):677-80. doi: 10.1054/ijom.2001.0209.
citation: Di Carlo R, Zara S, Ventrella A, Siani G, Da Ros T, Iezzi G, Cataldi A, Fontana A. Covalent Decoration of Cortical Membranes with Graphene Oxide as a Substrate for Dental Pulp Stem Cells. Nanomaterials (Basel). 2019 Apr 12;9(4):604. doi: 10.3390/nano9040604.
citation: Caballe-Serrano J, Munar-Frau A, Delgado L, Perez R, Hernandez-Alfaro F. Physicochemical characterization of barrier membranes for bone regeneration. J Mech Behav Biomed Mater. 2019 Sep;97:13-20. doi: 10.1016/j.jmbbm.2019.04.053. Epub 2019 May 4.
citation: Rossi R, Rancitelli D, Poli PP, Rasia Dal Polo M, Nannmark U, Maiorana C. The use of a collagenated porcine cortical lamina in the reconstruction of alveolar ridge defects. A clinical and histological study. Minerva Stomatol. 2016 Oct;65(5):257-68.