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1.
Drug Dev Res ; 85(3): e22188, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38678547

RESUMEN

Oral mucositis (OM) remains a significant toxicity among patients being treated with radiotherapy (RT) alone or with concomitant chemotherapy (CRT) for cancers of the head and neck (HNC). Given its clinical significance as an unmet need and its potential commercial viability, the pharmaceutical industry has been actively pursuing an effective intervention. Despite this interest and activity, only a few agents have been studied in Phase III trials (n = 6). The objective of this study was to identify common features that differentiate successful and failed Phase III OM trials. We used the United States Patent and Trademark Office Patent Public Search database to search patents with "oral mucositis" in the claims. We then searched ClinicalTrials.gov and PubMed to determine if Phase III or Phase II trial data for identified biologics/drugs had been published. We assessed each Phase III and Phase II trial for characteristics that may be associated with trial success or failure. We considered a study as a "success" if the primary endpoint reached statistical significance, and we considered a study as "failure" if the primary endpoint did not reach statistical significance. Of the three successful Phase III trials, one investigated avasopasem manganese (Galera Therapeutics) and two examined palifermin (Amgen). The three failed trials included those evaluating dusquetide (Soligenix), iseganan hydrochloride (IntraBiotics Pharmaceuticals), and clonidine (Monopar Therapeutics). We found that differences in the level of sponsor funding, patient inclusion criteria including radiation source and concomitant chemotherapy regimen, and concordance of primary efficacy outcomes between Phase II and Phase III trials influenced outcomes. To properly design clinical trials for OM in HNC patients, it is important that researchers and sponsors take note of specific study characteristics associated with success or failure, particularly with Phase III trials where the risks and costs are the highest.


Asunto(s)
Productos Biológicos , Ensayos Clínicos Fase III como Asunto , Neoplasias de Cabeza y Cuello , Estomatitis , Humanos , Neoplasias de Cabeza y Cuello/radioterapia , Neoplasias de Cabeza y Cuello/tratamiento farmacológico , Estomatitis/tratamiento farmacológico , Estomatitis/etiología , Productos Biológicos/uso terapéutico , Productos Biológicos/administración & dosificación , Quimioradioterapia/efectos adversos , Ensayos Clínicos Fase II como Asunto , Antineoplásicos/efectos adversos , Antineoplásicos/uso terapéutico
2.
J Dent Educ ; 2024 Apr 02.
Artículo en Inglés | MEDLINE | ID: mdl-38562110

RESUMEN

PURPOSE/OBJECTIVE: A career in healthcare is built on the foundations of continuous self-reflection and self-assessment. Previous studies have solely compared student self-assessment to faculty grades in a single discipline. The objective of this study was to investigate whether associations of a student's self-assessment skills exist across multiple disciplines in the predoctoral setting. METHODS: Sixty-five students from two class years at the Harvard School of Dental Medicine completed preclinical competency exams in dental anatomy waxing and operative dentistry. The difference between the student's self-assessment score and average faculty grade for each exercise was calculated as the student‒faculty (S-F) gap, which served as a proxy to determine how students evaluate their work. Regression analysis was performed to assess associations between wax-up and preclinical operative S-F gaps. RESULTS: Mean S-F gaps for waxing and preclinical operative procedures were positive (5.7 ± 6.1 and 7.6 ± 6.7, respectively). Additionally, students in the lower quartile tended to overestimate performance to a greater degree than their peers in the upper quartile. Furthermore, the waxing S-F gaps were positively associated with S-F gaps of each operative procedure, particularly with the combined operative exercise S-F gaps, where a statistically significant association was seen (coefficient = 0.28; p = 0.04). CONCLUSION(S): Previously, we identified a negative correlation between students' self-assessment skills (S-F gaps) and their preclinical performance. In this study, we further demonstrated an association of S-F gaps in two fundamental exercises: wax-up and operative dentistry. This underscores the roles of S-F gaps as possible indicators of students' preclinical and clinical performance, and it holds potential to become a widely standardized and applicable calculation that may help evaluate the effectiveness of the dental curricula and optimize student learning.

3.
J Dent Sci ; 19(1): 645-647, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38303857

RESUMEN

Spatial perception and psychomotor skills are critical components to clinical dentistry. However, measures within the dental school curricula have not been sufficiently studied and evaluated for their effectiveness in predicting preclinical performance. The objective of this study was to examine whether students' waxing skills are associated with preclinical operative performance. This study included 65 students from two class years at the Harvard School of Dental Medicine. Regression analysis was utilized to assess associations between waxing scores and operative exam scores. Waxing scores were found to be positively correlated with all operative practical exam scores and significantly associated with the class III resin composite restoration (coefficient, 0.42; P = 0.02) and the combined operative exam scores (coefficient, 0.33; P = 0.04). Wax-up assessments could serve as a predictor for preclinical performance and identify students who would benefit from additional assistance to help foster a more inclusive learning environment.

4.
Dent Traumatol ; 40(2): 144-151, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37818921

RESUMEN

BACKGROUND/AIM: Oral injuries such as oral soft tissue lacerations and contusions can occur in basketball by mechanisms such as running into other players or falling. Given a high enough impact force, dental injuries such as tooth fractures and avulsions can occur. Previous research has studied the different types of oral injuries as well as the mechanisms that cause them. Yet, the mechanisms resulting in dental injuries have remained unexplored. The aims of this study were to investigate the distribution of different oral injuries within each injury mechanism and evaluate which mechanisms were most likely to lead to a dental injury. MATERIALS AND METHODS: This is a retrospective cohort study using the National Electronic Injury Surveillance System (NEISS). Subjects who experienced oral injuries from basketball between January 1, 2003 and December 31, 2022 were included in this study. The independent variable was the injury mechanism. The dependent variable was the dental injury outcome (yes/no). Multivariate logistic regression was used to measure the association between the injury mechanism and the dental injury outcome. A p < .05 was considered statistically significant. RESULTS: This study included 4419 subjects who experienced oral injuries (national estimate, 138,980). Approximately 14.7% of oral injuries were dental injuries. Subjects experiencing collisions with objects such as walls or the basketball hoop (odds ratio (OR), 4.39; p < .001), falls (OR, 3.35; p < .001), or contact with the basketball (OR, 1.77; p = .006) had significantly higher odds of sustaining a dental injury relative to those experiencing contact with another player. CONCLUSIONS: Basketball players experiencing contact to the mouth have high odds of sustaining a dental injury. An understanding of injury mechanisms is important for medical teams to manage these injuries and for coaches to educate athletes on safe and proper playing styles. Furthermore, healthcare providers and basketball staff should encourage athletes to wear mouthguards to reduce the risk of traumatic dental injuries.


Asunto(s)
Traumatismos en Atletas , Baloncesto , Traumatismos de los Dientes , Humanos , Estados Unidos/epidemiología , Traumatismos de los Dientes/epidemiología , Traumatismos en Atletas/epidemiología , Baloncesto/lesiones , Estudios Retrospectivos , Boca/lesiones
5.
J Craniofac Surg ; 2023 Nov 29.
Artículo en Inglés | MEDLINE | ID: mdl-38018969

RESUMEN

The objective of this study was to evaluate which Olympic-style sports and activities are most likely to result in hospitalizations relating to head and neck injuries. This was a cross-sectional study using the National Electronic Injury Surveillance System (NEISS) database. Subjects with head and neck injuries from selected Olympic-style sports and activities between 2010 and 2022 were included. Independent variables were demographics and injury characteristics (injury location and sport). The primary outcome variable was hospitalization (yes/no). Survey-weighted descriptive, bivariate, and logistic regression statistics were computed to measure the association between demographic/injury variables and hospitalization. There were 175,995 subjects (national estimate, 5,922,584) meeting inclusion criteria. After adjusting for demographic and injury characteristics, head injuries (odds ratio [OR] = 2.17; 95% CI, 1.83-2.56; P<0.001) demonstrated higher odds of hospitalization compared with facial injuries. Injuries from cycling (OR = 2.52; 95% CI, 2.16-2.95; P<0.001), mountain biking (OR = 2.56; 95% CI, 1.80-3.65; P<0.001), and horseback riding (OR = 4.01; 95% CI, 2.76-5.83; P<0.001) demonstrated higher odds of hospitalization relative to baseball injuries. In conclusion, head and neck injuries associated with high velocity Olympic-style sports and activities such as cycling, mountain biking, and horseback riding had the highest odds of hospitalization.

7.
J Oral Maxillofac Surg ; 81(12): 1495-1503, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37743045

RESUMEN

BACKGROUND: Soccer is one of the most popular sports worldwide. However, it has risks of injury to craniomaxillofacial regions such as the head, neck, and mouth. PURPOSE: The purpose of this study is to determine which demographic and injury characteristics among soccer players with craniomaxillofacial injuries are associated with increased hospitalizations. STUDY DESIGN, SETTING, AND SAMPLE: This is a retrospective cohort study utilizing the National Electronic Injury Surveillance System. Subjects included in this study experienced an injury to a craniomaxillofacial area from soccer between January 1, 2003, and December 31, 2022. PREDICTOR VARIABLE: The predictor variables included demographics (age, sex, race) and injury characteristics (craniomaxillofacial region, diagnosis). MAIN OUTCOME VARIABLE: The primary outcome variable was injury severity defined as hospitalization outcome after injury (yes/no). The secondary outcome variable was the trends in the incidence of soccer craniomaxillofacial injuries over time (2003-2022). COVARIATES: The covariates were the heterogenous set of predictor variables in this study. ANALYSES: Descriptive statistics and univariate analyses were computed. Survey-weighted univariate and multivariate logistic regression were used to measure the association of demographic and injury variables with hospitalization outcome. Statistical significance was defined as P < .05. RESULTS: The study sample included 26,642 subjects (national estimate, 799,393). The national incidence of craniomaxillofacial soccer injuries generally increased between 2003 and 2012 and decreased between 2016 and 2020. Subjects in the ≥30 age group had increased odds of hospitalization compared to those in the 10-19 age group (odds ratio [OR], 2.12; P < .001). Compared to females, males had significantly higher odds of hospitalization (OR, 1.53; P < .001). Head (OR, 8.42; P < .001) and neck (OR, 15.8; P < .001) injuries had increased odds of hospitalization compared to facial injuries. Relative to contusions/abrasions, subjects with fractures (OR, 94.7; P < .001), dental injuries (OR, 41.3; P < .001), and concussions (OR, 5.33; P = .017) were at significantly higher odds of hospitalization. CONCLUSION AND RELEVANCE: Age, sex, craniomaxillofacial region, and diagnosis were significant predictors of hospitalization outcome after craniomaxillofacial soccer injury. Safer playing styles, use of mouthguards, and proper medical management may reduce future risks of craniomaxillofacial injury from soccer.


Asunto(s)
Traumatismos en Atletas , Traumatismos Faciales , Fracturas Óseas , Fútbol , Masculino , Femenino , Humanos , Estados Unidos/epidemiología , Traumatismos en Atletas/epidemiología , Fútbol/lesiones , Estudios Retrospectivos , Traumatismos Faciales/epidemiología , Incidencia
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