Browsing by Author "Sanz, David"
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- Effects of bilateral discectomy and bilateral discopexy on black merino sheep rumination kinematics: TEMPOJIMS – Phase 1 – pilot blinded, randomized preclinical studyPublication . Ângelo, David Faustino; Gil, Florencio Monje; González-García, Raúl; Mónico, Lisete; Sousa, Rita; Neto, Lia; Caldeira, Inês; Moura, Carla; Francisco, Luís Carlos; Sanz, David; Alves, Nuno; Salvado, Francisco; Morouço, PedroBackground: The temporomandibular joint interposal study (TEMPOJIMS) is a rigorous preclinical trial divided in 2 phases. In phase 1 the authors investigated the role of the TMJ disc and in phase 2 the authors evaluated 3 different interposal materials. The present work of TEMPOJIMS - phase 1, investigated the effects of bilateral discectomy and discopexy in sheep mastication and rumination. Methods: This randomized, blinded and controlled preclinical trial (in line with the ARRIVE guidelines) was conducted in 9 Black Merino sheep to evaluate changes in mastication and rumination after bilateral discectomy and bilateral discopexy, by comparing with a sham surgery control group. The outcomes evaluated were: (1) absolute masticatory time; (2) ruminant time per cycle; (3) ruminant kinematics, and (4) ruminant area. After baseline evaluation and surgical interventions, the outcomes were recorded over 3 successive days, every 30 days, for 6 months. Results: The first month after intervention seemed to be the critical period for significant kinematic changes in the discectomy and discopexy groups. However, 6 months after the bilateral interventions, no significant changes were noticed when compared with the control group. Conclusions: In this study, bilateral discectomy and discopexy had no significant effect in mastication and ruminatory movement. The introduction of kinematic evaluation presents a new challenge that may contribute to the improvement of future studies on the TMJ domain.
- Preclinical randomized controlled trial of bilateral discectomy versus bilateral discopexy in black merino sheep temporomandibular joint: TEMPOJIMS – Phase 1- histologic, imaging and body weight resultsPublication . Ângelo, David Faustino; Morouço, Pedro; Gil, Florencio Monje; Mónico, Lisete; González-Gárcia, Raúl; Sousa, Rita; Neto, Lia; Caldeira, Inês; Smith, Margaret; Smith, Susan; Sanz, David; Santos, Fábio Abade dos; Pinho, Mário; Carrapiço, Belmira; Cavaco, Sandra; Moura, Carla; Alves, Nuno; Salvado, Francisco; Little, ChristopherIntroduction: The role of temporomandibular joint (TMJ) surgery is not well defined due to a lack of quality randomized controlled clinical trials, comparing different TMJ surgical treatments with medical and placebo interventions. The temporomandibular joint interposal study (TEMPOJIMS) is a rigorous preclinical trial divided in 2 phases. In phase 1 the authors investigated the role of the TMJ disc and in phase 2 the authors evaluated 3 different interposal materials. The present work of TEMPOJIMS - phase 1, aims to evaluate histopathologic and imaging changes of bilateral discectomy and discopexy in Black Merino sheep TMJ, using a high-quality trial following the ARRIVE guidelines. Material and methods: This randomized, blinded and controlled preclinical trial was conducted in 9 Black Merino sheep to investigate histopathologic (primary outcome), imaging and body weight (secondary outcomes) changes after bilateral discectomy, discopexy and sham surgery. Results: Significant changes were noticed in discectomy group, both in imaging and histopathologic analyses. Body weight changes were most pronounced in the discectomy group in the first 4 months after surgery with recovery to baseline weight 6 months after surgery. Discopexy induced nonsignificant changes in histopathologic, imaging and body weight analyses. Conclusions: This study reinforces the importance of developing an effective interposal material to substitute the TMJ disc and the need to explore the molecular mechanisms that underlie TMJ cartilage degeneration. The study design proposed in TEMPOJIMS represents an important progress towards future rigorous TMJ investigations.
- A randomized controlled preclinical trial on 3 interposal temporomandibular joint disc implants: TEMPOJIMS-Phase 2Publication . Ângelo, David Faustino; Wang, Yadong; Morouço, Pedro; Monje, Florencio; Mónico, Lisete; González-Garcia, Raúl; Moura, Carla; Alves, Nuno; Sanz, David; Gao, Jin; Sousa, Rita; Neto, Lia; Faísca, Pedro; Salgado, Francisco; López Peña, Monica; Permuy, Maria; Munñoz, FernandoThe 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.
- Unilateral temporomandibular joint discectomy without interposal material in patients with disc perforation or fragmentation: a prospective studyPublication . Ângelo, David Faustino; Sanz, David; Cardoso, Henrique JoséObjective: Temporomandibular joint (TMJ) discectomy is one of the most popular surgical techniques for patients with an unsalvageable disc. Previous studies have demonstrated predictable results of dis-cectomy with optimal results in pain reduction and maximum mouth opening (MMO) improvement.However, those studies had most of the times wide-ranging inclusion criteria. This study was thereforeconducted to assess the role of unilateral TMJ discectomy in a well defined diagnosis.Methods: A 6-year prospective study was designed including patients treated with unilateral TMJ dis-cectomy without interposal material, preserving condyle and temporal fibrocartilage, for two specificintra-articular diagnosis: disc perforation and disc fragmentation.Results: A total of 19 patients were enrolled, with a mean age of 51.05 ± 13.71 (mean ± SD) years.Preoperative pain was 7.63 ± 1.89 (mean ± SD), MMO was 25.95 ± 10.27 mm (mean ± SD) and muscletenderness (MT) was 2.53 ± 0.77 (mean ± SD). The most common diagnosis was disc perforation. Afteran average of 37.9 months of follow-up time (range from 10 to 71 months), a statistically significant improvement of pain (P < 0.0001), MMO (P < 0.0001) and MT (P = 0.00011) was observed. Postoperatively,16 of 18 patients (89 %) showed a reduction in pain and improvement in MMO, fulfilling the criteria fora successful outcome of TMJ surgery. No second surgery was necessary. Conclusion: Unilateral TMJ discectomy without interposal material in patients with disc perforation or fragmentation seems to be an adequate technique. However, we encourage rigorous long-term studiesand new preclinical trials to pursuit a disc substitute, as relevant preclinical trials have demonstrated significant degenerative changes after TMJ discectomy.