Percorrer por autor "Salvado, Francisco"
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- Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)Publication . Ângelo, David Faustino; Monje, Florencio Gil; González-García, Raúl; Little, Christopher B; Mónico, Lisete; Pinho, Mário; Santos, Fábio Abade; Carrapiço, Belmira; Gonçalves, Sandra Cavaco; Morouço, Pedro; Alves, Nuno; Moura, Carla; Wang, Yadong; Jeffries, Eric; Gao, Jin; Sousa, Rita; Neto, Lia Lucas; Caldeira, Daniel; Salvado, FranciscoBackground: Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective: This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods: A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight Results: Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery, particularly in the TMJ field, by proposing a rigorous design in black Merino sheep. The authors also intend to test the feasibility of pilot outcomes. The authors expect to increase the quality of further studies in this field and to progress in future treatment options for patients undergoing surgery for TMJ disk replacement. Conclusions: The study has commenced, but it is too early to provide results or conclusions.
- Cut-off for the legal ages in the Portuguese Population by Third Maturity Index: Measures of AccuracyPublication . Pereira, Cristiana Palmela; Rodrigues, Ana; Santos, Adriana; Salvado, Francisco; Santos, Rui; Cameriere, RobertoObjectives: The aim of this study is to estimate the cut-off points for the Portuguese legal ages through the I3M, and to compare them with the methods of Demirjian, Nolla and Moorrees. Design: The lower third molars were analyzed on 348 orthopantomography's aged between 12 and 23 years in a Portuguese Population. The images were analyzed by ImageJ and the cut-off points were calculated for the respective legal ages of 14, 16, 18 and 21 years old. Results: The correlation between age and the I3M was 0.862, whereas with Demirjian's stadiums, Nolla's stages, and Moorrees’ stages the correlation coefficients were 0.863, 0.842 and 0.844, respectively. For the cut-off point of 0.08 for the age of 18, a sensitivity of 78.99 %, specificity of 93.48 %, an accuracy of 88.54 %, a positive predictive value of 86.24 % and a posteriori Bayes probability of 92.82 %. The cut-off points established for the ages of 14, 16, 18 and 21 years for the Portuguese population achieved an accuracy of 83.67 %, 85.67 %, 88.54 % and 87.11 %, respectively. Conclusion: Demirjian's method and Cameriere's method attain quite similar results. In certain ages, the methods of Nolla and Moorrees show higher sensitivity or higher specificity when compared to Cameriere's method, however this last method is more stable in terms of reliability and more suitable to use in the Portuguese population.
- Effects of bilateral discectomy and bilateral discopexy on black Merino sheep rumination kinematics: TEMPOJIMS – phase 1 – pilot blinded, randomized preclinical studyPublication . Ângelo, David; 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 e Phase 1- histologic, imaging and body weight resultsPublication . Ângelo, David Faustino; Morouço, Pedro; Gil, Florêncio Monje; Mónico, Lisete; González-Garcia, 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 e 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 . DF, Angelo; Wang, Y.; Morouço, Pedro; Monje, Florencio; Mónico, Lisete; González‐Garcia, Raúl; Moura, Carla; Alves, Nuno; Sanz, David; Gao, Jin; Sousa, Rita; Neto, Lia; Faísca, Pedro; Salvado, 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 im plants 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.