A randomized controlled preclinical trial on 3 interposal temporomandibular joint disc implants: TEMPOJIMS—Phase 2

Abstract

The effort to develop an effective and safe temporomandibular joint (TMJ) disc substitute has been one of the mainstreams of tissue engineering. Biodegradable customized scaffolds could approach safety and effectiveness to regenerate a new autologous disc, rather than using non‐biodegradable materials. However, it is still technically challenging to mimic the biomechanical properties of the native disc with biodegradable polymers. In this study, new 3D tailored TMJ disc implants were developed: (1) Poly(glycerol sebacate) (PGS) scaffold reinforced with electrospun Poly(εcaprolactone) (PCL) fibers on the outer surface (PGS+PCL); (2) PCL and polyethylene glycol diacrylate (PEGDA) (PCL+PEGDA); and (3) PCL. The TMJ implants were tested in a randomized preclinical trial, conducted in 24 black Merino sheep TMJ, perfoming bilateral interventions. Histologic, imaging, and kinematics analysis was performed. No statistical changes were observed between the PGS+PCL disc and the control group. The PCL+PEGDA and PCL groups were associated with statistical changes in histology (p = 0.004 for articular cartilage mid‐layer; p = 0.019 for structure changes and p = 0.017 for cell shape changes), imaging (p = 0.027 for global appreciation) and dangerous material fragmentation was observed. No biomaterial particles were observed in the multi‐organ analysis in the different groups. The sheep confirmed to be a relevant animal model for TMJ disc surgery and regenerative approaches. The PCL and PCL+PEGDA discs presented a higher risk to increase degenerative changes, due to material fragmentation. None of the tested discs regenerate a new autologous disc, however, PGS+PCL was safe, demonstrated rapid resorption, and was capable to prevent condyle degenerative changes.

Additive Manufactured Poly(ε-caprolactone)-graphene Scaffolds: Lamellar Crystal Orientation, Mechanical Properties and Biological Performance

“…3D PCL/GPN scaffolds were fabricated using the fused deposition modelling (FDM) technique with the Bioextruder, a biomanufacturing system developed at Centre for Rapid and Sustainable Product Development of the Polytechnic of Leiria (Leiria, Portugal) [28][29][30][31]. This is a pellet-fed-extruder-based system.…”

Advances in Tissue Engineering of the Temporomandibular Joint Disc: An Overview of Current Status and Future Directions

“…e PCL + PEGDA and PCL implants showed detrimental changes when compared to the discopexy controls [41]. e results reimpose that we should rather not interpose any material in the joint than to use an unsafe and unreliable material.…”

Decellularized small intestine submucosa device for temporomandibular joint meniscus repair: Acute timepoint safety study

“…Furthermore, as the minipig was used, a complex fenestration procedure had to be performed in order to reach the meniscus without fracturing the zygomatic arch. There is another group that attempted to replace the entire TMJ meniscus in a sheep model, but the Poly(εcaprolactone) devices used either did not degrade or eroded the joint articular surfaces [44][45][46][47][48][49].…”