Efficacy of 660 nm Photobiomodulation in Burning Mouth Syndrome Management: A Single-Blind Quasi-Experimental Controlled Clinical Trial.

Background: Burning mouth syndrome (BMS) is characterized by a burning sensation of the oral mucosa without any evidence of clinical signs or underlining condition. Several treatment modalities have been utilized with various results and levels of evidence. Lately, photobiomodulation (PBM) has emerged as a noninvasive effective therapy due to its anti-inflammatory and biostimulatory effects, especially the low-power laser setting of red wavelength. Objective: This single-blind quasi-experimental controlled clinical trial aimed to evaluate the PBM effectiveness at a low level of red laser light in patients with BMS compared with sham control. Materials and methods: Thirty patients diagnosed with BMS were consecutively assigned to intervention (PBM therapy) and control (sham) groups. The protocol for PBM dosimetry was as follows: laser 660 nm; spot size: 0.04 cm2; power output: 100 mW; emission mode: continuous wave; power density: 6 J/cm2; irradiation time: 10 sec per point within 1 cm2 surface area of the symptomatic area. The treatment protocol was based on once a week for a total of 10 sessions. Results: Our results showed no statistically significant difference in reduction of pain intensity between the two groups at all the evaluated timepoints during the course of treatment. However, in both groups, we observed a statistically significant reduction of maximum pain intensity of 50% compared with patient-self reporting before the treatment. Conclusions: Further randomized clinical trials to validate our positive results with a large sample size with a long-term follow-up and understanding further the sham placebo effect are warranted.

Application of clinical value assessment of treatment protocols in guideline development: taking the WFAS Clinical Practice Guideline of Acupuncture and Moxibustion for Migraine as an example. / 治疗方案临床价值评估在指南制定中的应用.

To enhance the clinical applicability of guidelines and provide more effective guidance for clinical practice, a clinical value assessment was conducted during the development of the World Federation of Acupuncture-Moxibustion Societies (WFAS) Clinical Practice Guideline of Acupuncture and Moxibustion for Migraine, which involved the evaluation of 59 acupuncture and moxibustion treatment protocols from randomized controlled trials (RCTs). This article introduced the methodology, content and results of the clinical value assessment of RCT-based acupuncture and moxibustion treatment protocols, which involved the integration of historical and contemporary medical evidence and expert consensus. It served as a methodological reference for the future development of acupuncture and moxibustion clinical practice guidelines.

Photobiomodulation therapy combined with static magnetic field is better than placebo in patients with fibromyalgia: a randomized placebo-controlled trial.

BACKGROUND: Fibromyalgia is a syndrome characterized by generalized chronic pain and tenderness in specific areas. Photobiomodulation therapy (PBMT) using low-level laser therapy and/or light emitting diode therapy is an electrophysical agent that can be used alone or together with a static magnetic field (PBMT-sMF) to promote analgesia in several health conditions. Little evidence exists regarding the effects of using PBMT and PBMT-sMF in patients with fibromyalgia; this evidence is conflicting. AIM: We aimed to investigate the effects of using PBMT-sMF versus a placebo on reduction of the degree-of-pain rating, impact of fibromyalgia, pain intensity, and satisfaction with treatment in patients with fibromyalgia. DESIGN: A prospectively registered, monocentric, randomized placebo-controlled trial, with blinding of patients, therapists, and assessors, was performed. SETTING: The study was conducted at the Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT) in Brazil, between March and October 2020. POPULATION: Ninety female patients with fibromyalgia were randomized to undergo either PBMT-sMF (N.=45) or placebo (N.=45) treatment. METHODS: Patients from both groups received nine treatment sessions, three times a week, for 3 weeks. Clinical outcomes were collected at baseline, the end of treatment, and at the follow-up appointment 4 weeks post-treatment. The primary outcome was the degree-of-pain rating, measured by the reduction of the tender point count. RESULTS: A decrease in the degree-of-pain rating was observed in patients allocated to the PBMT-sMF group, decreasing the number of tender points when compared to placebo group at the end of treatment (P<0.0001) and at the follow-up assessment (P<0.0001). Patients did not report any adverse events. CONCLUSIONS: PBMT-sMF is superior to placebo, supporting its use in patients with fibromyalgia. CLINICAL REHABILITATION IMPACT: PBMT-sMF might be considered an important adjuvant to the treatment regimens of patients with fibromyalgia.

Clinical efficacy of neurofeedback protocols in treatment of Attention Deficit/Hyperactivity Disorder (ADHD): A systematic review.

Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder of childhood and its effects mostly continue to adulthood. Neurofeedback training has shown promising results in the treatment of ADHD. However, there is no yet consensus as to the efficacy of neurofeedback in comparison to stimulant medication. Despite a large number of meta-analyses and comparative reviews on the effects of neurofeedback in the treatment of ADHD, there is a lack of comparative reviews on the efficacy of neurofeedback protocols. This review aims at examining the effect of different training protocols on the efficacy of neurofeedback in the treatment of ADHD across specific research studies published between 2017 and 2022. Altogether, a total of 916 records were identified and 18 articles met the inclusion criteria. Findings show that the efficacy of different neurofeedback protocols has been comparable to the efficacy of stimulant medications. Nevertheless, there is still room for more clinical trials on neurofeedback protocols for ADHD since some studies suggest not using neurofeedback as a stand-alone treatment for ADHD. To my knowledge, this systematic review is the first to review neurofeedback protocols for ADHD. This study provides significant implications and directions for researchers to conduct research, on alternatives to stimulant medications for ADHD, in the future.

Validação do conteúdo de um protocolo de avaliação da motricidade orofacial em lactentes / Content validation of an orofacial myofunctional assessment protocol for infants / Validación del contenido de un protocolo para la evaluación de la motricidad orofacial en bebés

Introdução: Muitos estudos têm se dedicado a compreender melhor a dinâmica da avaliação das estruturas e funções estomatognáticas de lactentes; até a presente pesquisa não foram encontrados estudos específicos para essa faixa etária, até recentemente. Objetivo: Validar o conteúdo de um instrumento fonoaudiológico de avaliação da motricidade orofacial para lactentes na faixa etária de um mês a dois anos. Metodologia: Foi elaborado o instrumento para "avaliação fonoaudiológica da motricidade orofacial de lactentes de um mês a dois anos" a partir dos dados obtidos na literatura. A validação do conteúdo do instrumento se deu por meio da avaliação de quatro juízes para clareza dos itens propostos no protocolo e da representatividade dos mesmos no processo de validação do conteúdo. Os juízes classificaram cada item quanto à clareza, a partir de uma escala tipo Likert de quatro pontos, sendo: (4) muito claro, (3) claro, (2) pouco claro, (1) sem clareza, com o propósito de realizar a validação do conteúdo por meio da aplicação da equação do Índice de Validação do Conteúdo (IVC). Resultados: O protocolo desenvolvido possui 8 itens e uma breve anamnese: Hábitos Orais; Avaliação Estrutural; Respiração; Voz; Avaliação Funcional; Alimentação e Deglutição - líquidos e alimentos em pedaços; Diagnóstico Fonoaudiológico. A etapa seguinte contou com a análise da representatividade e para clareza dos itens do protocolo pelos juízes, e após a segunda análise, a validação do conteúdo resultou na permanência dos 8 itens com Índice de Validade de Conteúdo total de 100%. Conclusão: O conteúdo do protocolo foi considerado válido para uso na avaliação do público-alvo, comprovado por profissionais com experiência na área. A versão final do Protocolo de avaliação fonoaudiológica da motricidade orofacial de bebês foi finalizada com 8 itens de avaliação. (AU)

Introduction: The instruments for evaluating the structures and functions of the stomatognathic system in babies have been lacking in studies. Objective: To validate the content of a speech-language instrument to assess orofacial motricity for babies aged between one month and two years old. Methodology: The instrument for "speech-language assessment of the orofacial motricity of babies from one month to two years old" was created based on the data obtained by the integrative review. The instrument's content was validated through the evaluation of four judges. The judges classified each item according to clarity, based on a four-point Likert scale, as follows: (4) very clear, (3) clear, (2) lightly clear, (1) unclear, to perform content validation by applying the Content Validation Index (CVI) equation. Results: The developed protocol has eight items and a brief anamnesis: Oral Habits; Structural Assessment; Breathing; Voice; Functional Assessment; Feeding and Swallowing - liquids and food in pieces; and Speech-Language Diagnosis. The next step included the analysis of the representativeness of the protocol items by the judges. After the second analysis, the validation of the content resulted in the permanence of the eight items with a total Content Validity Index of 100%. Conclusion: The content of the protocol was considered valid for use in the evaluation of the target audience, proven by people with experience in the area. The final version of the Protocol for the Speech-Language Pathology Assessment of Orofacial Motricity in Babies was completed with eight assessment items. (AU)

Introducción: Los instrumentos para la evaluación de las estructuras y funciones del sistema estomatognático en los bebés han mostrado falta de estudios. Objetivo: Validar el contenido de un instrumento de fonoaudiología para la evaluación de la motricidad orofacial en bebés de un mes a dos años de edad. Metodología: Inicialmente, se llevó a cabo la elaboración del instrumento para la "evaluación logopédica de la motricidad orofacial de bebés de un mes a dos años de edad" propiamente dicho, a partir de los datos obtenidos por la revisión integradora. La validación del contenido del instrumento se realizó a través de la evaluación de cuatro jueces. Los jueces calificaron cada ítem en términos de claridad, utilizando una escala de Likert de cuatro puntos, de la siguiente manera: (4) muy claro, (3) claro, (2) poco claro, (1) poco claro, con el propósito de realizar la validación de contenido a través de la aplicación de la ecuación del Índice de Validación de Contenido (CVI). Resultados: después de la lectura y discusión de los artículos, fue posible desarrollar el protocolo que contiene 8 ítems y una breve anamnesis, que son: Hábitos Orales; Evaluación Estructural; Respiración; Voz; Evaluación Funcional; Alimentación y deglución: líquidos y alimentos en trozos; y; Diagnóstico de Patología del Habla-Lenguaje. El siguiente paso fue el análisis de la representatividad de los ítems del protocolo por parte de los jueces, y luego del segundo análisis, la validación de contenido resultó en la permanencia de 8 ítems con un Índice de Validez de Contenido total del 100%. Conclusión: El contenido del protocolo se consideró válido para su uso en la evaluación del público objetivo, confirmado por personas con experiencia en el área. La versión final del Protocolo de evaluación de la patología del habla y el lenguaje para la motricidad orofacial en bebés se completó con 8 ítems de evaluación. (AU)

Multimodal non-invasive non-pharmacological therapies for chronic pain: mechanisms and progress.

BACKGROUND: Chronic pain conditions impose significant burdens worldwide. Pharmacological treatments like opioids have limitations. Non-invasive non-pharmacological therapies (NINPT) encompass diverse interventions including physical, psychological, complementary and alternative approaches, and other innovative techniques that provide analgesic options for chronic pain without medications. MAIN BODY: This review elucidates the mechanisms of major NINPT modalities and synthesizes evidence for their clinical potential across chronic pain populations. NINPT leverages peripheral, spinal, and supraspinal mechanisms to restore normal pain processing and limit central sensitization. However, heterogeneity in treatment protocols and individual responses warrants optimization through precision medicine approaches. CONCLUSION: Future adoption of NINPT requires addressing limitations in standardization and accessibility as well as synergistic combination with emerging therapies. Overall, this review highlights the promise of NINPT as a valuable complementary option ready for integration into contemporary pain medicine paradigms to improve patient care and outcomes.

Can vitamin B6 alleviate the adverse reactions of quadruple anti-Helicobacter pylori regimen? : randomized controlled trial.

BACKGROUND: Vitamin B6 is an essential water-soluble vitamin for humans. It is often used to prevent a variety of neuropathies, relieve vomiting, and relieve symptoms such as hand and foot neuritis. AIM: To evaluate whether vitamin B6 can alleviate the adverse reactions caused by the quadruple anti-Helicobacter pylori treatment regimen containing minocycline and metronidazole. METHODS: In this randomized controlled trial, 280 patients with H. pylori infection were randomly placed into one of two treatment groups-the conventional treatment group and the vitamin B6 supplement treatment group-for 2 weeks. The primary endpoint was the total incidence of adverse reactions up to 2 weeks after treatment initiation. The study was designed according to CONSORT Medicinal Interventions. And it was registered with Chinese Clinical Trial Registry under the number ChiCTR2100053833. RESULTS: In terms of efficacy, vitamin B6 does not affect the efficacy of conventional regimen. In the vitamin B6 supplement treatment group, the incidence of adverse reactions was 56.92%, which was significantly lower than the 74.62% observed in the conventional treatment group. In addition, the severity of adverse reactions was also significantly reduced. The proportion of moderate to severe central nervous system symptoms decreased from 58.7 to 14.63%. And, the proportion of moderate to severe gastrointestinal reactions decreased from 33.33 to 0%. We speculate that the mechanism of vitamin B6 of reducing adverse reaction may be related to the production of GABA in the brain. CONCLUSIONS: Vitamin B6 can alleviate adverse reactions of the quadruple anti-H. pylori regimen containing minocycline and metronidazole.

The clinical impact of implementation of a nutritional treatment protocol in critically ill adults with SARS-CoV-2 infection.

INTRODUCTION: The critical patient affected by SARS-CoV-2 is at risk of malnutrition. The need to avoid volume overload and manoeuvres that delay reaching nutritional requirements such as pronation make the nutritional approach to these patients complex. To ensure adequate treatment, a nutritional support protocol was developed as a clinical practice guideline adapted to the COVID-19 patient. OBJECTIVE: To describe and analyse the results of introducing a nutritional support protocol aimed at SARS-CoV-2 patients admitted to the intensive care unit (ICU) of the Consorcio Hospital General Universitario de Valencia (CHGUV) from March to May 2020. MATERIAL AND METHODS: Observational, descriptive, retrospective and longitudinal design to evaluate compliance with a nutritional support protocol. RESULTS: Thirty-one consecutive patients were included but nutritional follow-up could not be performed in eight. Of the remaining 23 patients, only eight reached 80% of caloric requirements before the tenth day after starting treatment (good compliance group) and 15 after the eleventh day (poor compliance group). In the group with «good compliance¼ 75% (n=6) were discharged and 25% died (n=2), compared to the group with «bad compliance¼ where 53% (n=8) were discharged and 47% (n=7) died (Chi square test, p-value=0.019). Those patients who reached 80% of caloric needs during ICU stay had a shorter length of stay compared to those who did not (median days of admission=14, IQR=10-16 and median days of admission=22, IQR=13-39, p-value=0.025). CONCLUSIONS: Introducing a nutritional protocol during the first weeks of the SARS-CoV-2 pandemic could improve clinical outcomes by promoting healing and reducing associated complications.

Tuina in a Frozen Shoulder Rat Model: An Efficient and Reproducible Protocol.

Frozen shoulder (FS) is a common condition with no defined optimal therapy. Tuina therapy, a traditional Chinese medicine (TCM) technique used to treat FS patients in Chinese hospitals, has demonstrated excellent results, but its mechanisms are not fully understood. Building on a previous study, this work aimed to develop a Tuina protocol for an FS rat model. We randomly divided 20 SD rats into control (C; n = 5), FS model (M; n = 5), FS model Tuina treatment (MT; n = 5), and FS model oral treatment (MO; n = 5) groups. This study used the cast immobilization method to establish the FS rat model. The effect of Tuina and oral dexamethasone on the glenohumeral range of motion (ROM) was evaluated, and the histological findings were assessed. Our study showed that Tuina and oral dexamethasone were able to improve shoulder active ROM and preserve the structure of the capsule, with Tuina therapy proving to be more effective than oral dexamethasone. In conclusion, the Tuina protocol established in this study was highly effective for FS.

Drivers of physician decision-making and patient perspectives across lines of therapy in multiple myeloma in the USA.

Aim: To explore treatment selection for relapsed/refractory multiple myeloma (RRMM), which remains complex due to heterogeneity of available treatments and lack of defined standard of care. Patients & methods: The Adelphi Real World MM Disease Specific Programme surveyed physicians in the USA and their patients with MM to collect real-world data on patterns and perceptions of MM treatment across lines of therapy (LOT). Results: Triplets were the most common regimens across each LOT. Physicians reported efficacy-related factors, health insurance coverage, and clinical guidelines as key determinants of treatment choice regardless of LOT. Patients identified better quality of life as the most important treatment benefit. Conclusion: The DSP RW data highlight drivers of RRMM treatment choice from physicians' and patients' perspectives and need for a more holistic approach to guidelines and clinical trials that encompasses patient perspectives.

Multiple myeloma (MM) is an incurable cancer of white blood cells. Treatments tend to become less effective when taken for long periods of time, meaning that patients often receive several different treatments over the course of their disease. Many different drugs and drug combinations are now available for patients with MM. As there is no standardized approach for the treatment of MM, it can be challenging for physicians to choose between the various complex treatment options for their patients, and the key factors that influence physicians' treatment choices remain unclear. In this study, we used information from a survey of physicians and their patients with MM in the USA to investigate which treatments were used most commonly and how physicians and patients made decisions about their treatment. We found that patients with MM were typically treated with a combination of three drugs which differed between patients. When deciding which treatment to prescribe to their patients, physicians primarily considered factors related to how well a treatment works and, in-turn, prolong a patient's life, but this was also considered by physicians to be an area for improvement. While patients also favored treatments associated with a longer life, they more commonly favored those associated with a better quality of life. These findings show that quality of life is important to patients receiving treatment for MM and should be taken into account by physicians when choosing a treatment for their patients.

Post-Recovery Relapse of Children Treated with a Simplified, Combined Nutrition Treatment Protocol in Mali: A Prospective Cohort Study.

The present study aimed to determine the 6-month incidence of relapse and associated factors among children who recovered from acute malnutrition (AM) following mid-upper arm circumference (MUAC)-based simplified combined treatment using the ComPAS protocol. A prospective cohort of 420 children who had reached a MUAC ≥ 125 mm for two consecutive measures was monitored between December 2020 and October 2021. Children were seen at home fortnightly for 6 months. The overall 6-month cumulative incidence of relapse [95%CI] into MUAC < 125 mm and/or edema was 26.1% [21.7; 30.8] and 1.7% [0.6; 3.6] to MUAC < 115 mm and/or edema. Relapse was similar among children initially admitted to treatment with a MUAC < 115 mm and/or oedema and among those with a MUAC ≥ 115 mm but <125 mm. Relapse was predicted by lower anthropometry both at admission to and discharge from treatment, and a higher number of illness episodes per month of follow-up. Having a vaccination card, using an improved water source, having agriculture as the main source of income, and increases in caregiver workload during follow-up all protected from relapse. Children discharged as recovered from AM remain at risk of relapsing into AM. To achieve reduction in relapse, recovery criteria may need to be revised and post-discharge strategies tested.

Standardised 25-Step Traditional Thai Massage (TTM) Protocol for Treating Office Syndrome (OS).

Traditional Thai massage (TTM) is a unique form of whole body massage practiced to promote health and well-being in Thailand since ancient times. The goal of the present study was to create a standardised TTM protocol to treat office syndrome (OS) diagnosed based on the identification of the palpation of at least one so-called myofascial trigger point (MTrP) in the upper trapezius muscle. The new 90 min TTM protocol, which was developed following appropriate review of the literature and in consultation with relevant experts, has 25 distinct steps (20 pressing steps, 2 artery occlusion steps, and 3 stretching steps). Eleven TTM therapists treated three patients each using the new 90 min TTM protocol. All of the therapists reported scores greater than 80% in respect to their satisfaction and confidence to deliver the protocol, and all of the patients gave the treatment a satisfaction score of greater than 80%. The treatment produced a significant reduction in pain intensity measured on a Visual Analogue Scale (VAS), with minimum and maximum values of 0 and 10 cm, of 2.33 cm (95% CI (1.76, 2.89 cm), p < 0.001) and significant increase in pain pressure threshold (PPT) of 0.37 kg/cm2 (95% CI (0.10, 0.64 kg/cm2), p < 0.05). The protocol was revised based on the feedback and the results obtained, and the new standardised TTM protocol will be applied in a randomised control trial (RCT) to compare the efficacy of TTM and conventional physical therapy (PT) for treating OS.

Systematic Review on Protocols of Coenzyme Q10 Supplementation in Non-Surgical Periodontitis Therapy.

This systematic review focuses on the different study protocols on CoQ10 as an adjunct in non-surgical periodontitis therapy. The study protocol was developed following PRISMA guidelines and was registered in PROSPERO (CRD42021156887). A sensitive search up to January 2022 considered MEDLINE via PubMed and Web of Science, Embase, Web of Science Core Collection via Web of Science, Google Scholar, Cochrane CENTRAL, WHO (ICTRP), ClinicalTrials.gov, and grey literature. Randomized controlled (SRP with/without placebo) clinical trials (RCTs) on all types of CoQ10 administration were included. The primary outcome was probing pocket depth (PPD). Secondary outcomes were bleeding on probing, clinical attachment loss, and gingival and plaque indices. Twelve RCTs with local and five with systemic CoQ10 administration were included. The study protocols were heterogeneous. Local CoQ10 administration was performed once or several times in a period up to 15 days. Systemic CoQ10 was applied twice or three times daily for six weeks up to four months. The reporting quality was low, including missing information about CoQ10 doses. Risk of bias was high or unclear. About half of the studies reported significant group differences for PPD. Until now, no statement on the effectiveness of CoQ10 in non-surgical periodontitis therapy is possible. Further high-quality RCTs are necessary and should consider the protocol recommendations of this review.

Transcutaneous electrical nerve stimulation for pelvic pain: A scoping review of treatment protocols, practical indications, and caveats.

BACKGROUND: Neuromodulation (NM) is a family of therapies based on electrical stimulation to target specific nerves that control LUTS (Lower Urinary Tract Symptoms) and pain. The aim is to modulate what is happening within the nervous system to achieve therapeutic effects. A particular type of neuromodulation, called TENS (Transcutaneous Electrical Nerve Stimulation), has proven effective for treating pelvic pain. The available evidence provides indications regarding the many aspects of TENS that influence therapeutic effects, but a comprehensive review has yet to be conducted. METHODS: Scoping review on Pubmed, CINAHL, Embase, Scopus, and Web of Science, including clinical trials, reviews, case studies or series, and other descriptive studies, according to the Joanna Briggs and PRISMA methodology. RESULTS: The 31 papers retrieved allowed the formulation of precise indications about the DOs and DON'Ts of electrode placement, waveform, pulse duration, pulse frequency, amplitude, session duration, and frequency of sessions. This paper also discusses the biochemical and neuro urological mechanisms of TENS. CONCLUSION: TENS effectiveness is influenced by many factors, some self-evident, others subtle, which this paper elucidates. Pelvic pain requires a multimodal approach, of which TENS is just a part. TENS should therefore be viewed as one of the components of the rehabilitation program in the frame of thorough and continuous patient assessment.

Development of Medication Administration Protocols for In-Home Pediatric Feeding Cases.

Medication administration can be a significant issue in pediatric populations, and especially with patients with developmental disabilities and comorbid feeding disorders. Research has focused largely on consumption of solids rather than medication and liquids in pediatric feeding programs, with most studies being conducted within specialized hospital settings in the United States. No studies to our knowledge have detailed treatment evaluations for medication administration in pediatric feeding except for a few studies on pill swallowing. We report results of treatment protocols for medication administration using empirically-supported treatments in a short-term intensive home-based behavior-analytic program in Australia. Two males with autism spectrum and pediatric feeding disorders participated. We used a multiple baseline single-case experimental design for medication administration conducted concurrently with a treatment evaluation for solid foods. Consumption increased in number (9; supplements, laxatives, pain relievers), flavors (8; chocolate, blackcurrent and apple, strawberry, lemon-lime, orange, chocolate-vanilla, cherry, apple), forms (4; thin and thick liquids, chewables, gummies), and delivery methods (5; finger-fed, spoon, cup, medicine spoon, medicine cup) within the first treatment session. For one participant, we taught open cup drinking for a variety of liquids (milk, juices, medications). For both participants, we taught self-feeding with utensils for thick liquid medications. Treatment results were similar for solids and participants increased food variety to over 160 across food groups. All goals were met including training parents to maintain gains at home.

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters.

BACKGROUND: Noninvasive transcutaneous vagus nerve stimulation (tVNS) has promising therapeutic potential in a wide range of applications across somatic and psychiatric conditions. Compared with invasive vagus nerve stimulation, good safety and tolerability profiles also support the use of tVNS in pediatric patients. Potential neurodevelopment-specific needs, however, raise concerns regarding the age-appropriate adjustment of treatment protocols and applied stimulation parameters. OBJECTIVE: In this study, we aimed to review registered trials and published studies to synthesize existing tVNS treatment protocols and stimulation parameters applied in pediatric patients. MATERIALS AND METHODS: A systematic search of electronic data bases (PubMed, Scopus, MEDLINE, Cochrane Library, and PsycINFO) and ClinicalTrials was conducted. Information on patient and study-level characteristics (eg, clinical condition, sample size), the tVNS device (eg, brand name, manufacturer), stimulation settings (eg, pulse width, stimulation intensity), and stimulation protocol (eg, duration, dosage of stimulation) was extracted. RESULTS: We identified a total of 15 publications (four study protocols) and 15 registered trials applying tVNS in pediatric patients (<18 years of age). Most of these studies did not exclusively address pediatric patients. None of the studies elaborated on neurodevelopmental aspects or justified the applied protocol or stimulation parameters for use in pediatric patients. CONCLUSIONS: No dedicated pediatric tVNS devices exist. Neither stimulation parameters nor stimulation protocols for tVNS are properly justified in pediatric patients. Evidence on age-dependent stimulation effects of tVNS under a neurodevelopment framework is warranted. We discuss the potential implications of these findings with clinical relevance, address some of the challenges of tVNS research in pediatric populations, and point out key aspects in future device development and research in addition to clinical studies on pediatric populations.

EFFECT OF SURFACE TREATMENT PROTOCOLS OF ZIRCONIUM DIOXIDE MULTILAYER RESTORATIONS ON FUNCTIONAL PROPERTIES OF THE HUMAN ORAL MUCOSA STROMAL CELLS.

Aim - to study the effect of protocols of surface treatment of zirconium dioxide multilayer restorations on the functional properties of stromal cells of the human oral mucosa using molecular biological methods. For all experiments, identical standardized specimens of different types of zirconia with a diameter of 10 mm and a height of 1 mm were used. These types included Katana (Kuraray Noritake Dental, Tokyo, Japan) HTML (control) UTML, STML and ZirCAD Prime (Ivoclar Vivadent). DMEM/F12 growth medium (Paneco, Russian Federation) with addition of fetal calf serum (Gibco, USA) up to 10% and penicillin-streptomycin (Paneco, Russian Federation) up to 1% was used in the experiment. Cells were detached from the culture substrate with trypsin-EDTA solution (Paneco, RF) and their number and viability were assessed using an automatic counter TC-20 (Bio-Rad, USA). For repopulation, samples were transferred into wells of a 96-well culture plate (1 sample in 1 well) and cell suspension was layered at the rate of 12.5 thousand or 25 thousand live cells per well. After 48 hours, the cytotoxic properties of the tested samples were evaluated in vitro. According to the results of MTT test we can conclude that samples of ZirCad Prime and Katana UTML groups do not show cytotoxic properties (score "0" on the cytotoxicity scale according to GOST R ISO 10993-5-2009 "National Standard of the Russian Federation. Medical devices. Evaluation of biological effect of medical devices. Part 5. Studies on cytotoxicity: in vitro methods"). The samples of Katana STML group samples were slightly reduced compared to the control (about 12%), nevertheless, these samples can also be considered non-cytotoxic. Analyzing the direct contact with the material in all samples, a good occupancy of the material by cells was observed, in particular, the polished surface prevailed over the glazed one, however, this difference is not statistically significant. Analysis of human oral stromal cells to zirconium dioxide showed no statistically significant effect of different surface treatment protocols. However, the number of fibroblasts prevailed on the polished surface.

Visual Analysis of Nutrient Deficiency and Treatment Protocols in Bariatric Surgery Based on VOSviewer.

Objective: To analyze the global literature on nutritional deficiencies in bariatric surgery (BS) since January 1, 1985, and to discuss the current status of research, research hotspots, and new development trend and treatment of nutritional deficiency in bariatric surgery. It provides ideas and basis for promoting the development of bariatric surgery and new alternative therapy or treatment protocols. Methods: The Web of Science (WOS) database core collection was used as the data source, and VOSviewer 1.6.17 software was used to search the literature on the topic of "nutritional deficiencies in bariatric surgery." The number of published literature, the distribution of authors, institutions, and countries, keyword cooccurrences, and journal cocitations were visualized and analyzed. Results: A total of 1015 relevant publications was obtained after searching and screening, and the overall trend of literature published was on the rise. The most published countries, institutions, and authors were USA, University of Sao Paulo, Ramalho, Andrea; Obesity Surgery has been the most frequently cited journal (7943 citations), and the top 10 journals had high impact factors. Keyword cooccurrence analysis showed that "bariatric surgery" and "nutritional deficiencies" are the hot topics of research in this field. Conclusion: There is an urgent need for bariatric surgery issuing institutions and authors to strengthen cross-institutional, cross-team, and multicenter and multidisciplinary cooperation, to promote and facilitate the exchange and cooperation in the field of bariatric surgery between developed countries in Europe and America and developing countries in Asia, Africa, and Latin America, to draw the attention of developing countries to the health problems caused by obesity, and to encourage and support the development of developing countries in this field. Bariatric surgery, obesity, weight loss, Y-type gastric bypass, gastric bypass, and nutritional deficiency are the hot research topics in the field of nutritional deficiency in bariatric surgery, and metabolic surgery, single anastomosis gastric bypass, micronutrient supplementation, micronutrient deficiency, intestinal microbiology, and guidelines are the new trends in this field.

Protocol proposal for early dental care in infants with cerebral palsy

Introduction: Children with cerebral palsy (CP) are at high risk of developing oral diseases. Objective: To propose an early dental care protocol for infants with CP. Materials and Methods: A computerized systematic search was performed in the PubMed, Scopus and Embase electronic databases for relevant articles. An early dental care protocol was then proposed for infants with cerebral palsy focused on comprehensive care with a multidisciplinary approach and effective health promotion by caregivers. Results: Fifteen published papers were included in the present literature review and protocol proposal. The protocol comprised the following topics: First dental visit, aspects related to the appointment, oral hygiene recommendations, dietary recommendations and recommendations for the prevention and control of harmful oral habits. The first dental visit should occur prior to the eruption of the teeth. As a special group, it is important to determine the affective bond between the patient and caregiver who will receive the oral health care recommendations. During the clinical examination, the correct positioning and stabilization of the infant is important for the control of involuntary movements and the minimization of swallowing difficulties. Counseling with regards to adequate oral hygiene, a healthy diet and the prevention of harmful oral habits is important to the prevention of dental diseases. Children with oral-motor motility problems and feeding difficulties should be referred to therapeutic follow-up. Due to the neuropsychomotor disorders often found in cerebral palsy, affected children are more vulnerable to oral diseases. Thus, oral health care must be performed as early as possible by the parents/caregivers of these children. Conclusion: Individuals with cerebral palsy are at greater risk of developing oral problems. Thus, oral health programs starting in early childhood and targeting the specificities of these individuals is a strategy for minimizing the occurrence of such problems and the associated burden.

Introdução: Crianças com Paralisia Cerebral (PC) apresentam um alto risco para o desenvolvimento de doenças bucais. Objetivo: Propor um protocolo de atendimento odontológico precoce para lactentes com PC. Materiais e Métodos: Foi realizada uma busca computadorizada sistemática nas bases de dados eletrônicas PubMed, Scopus e Embase. Também foi desenvolvida uma proposta de protocolo de atendimento a bebês com Paralisia Cerebral com foco no cuidado integral, abordagem transdisciplinar e promoção efetiva da saúde pelos cuidadores. Resultados: Foram incluídos 15 artigos publicados na literatura científica. O protocolo desenvolvido é composto pelos seguintes tópicos: Primeira consulta odontológica, tempo ideal da consulta, recomendações de higiene bucal, recomendações sobre dieta e recomendações sobre prevenção e controle dos hábitos bucais. A primeira visita ao dentista deve ser feita antes da erupção do primeiro dente. Como um grupo especial, é importante determinar o vínculo afetivo entre o paciente e o cuidador que receberá as recomendações de cuidados com a saúde bucal. Durante o exame clínico, a correta posição e estabilização do bebê na cadeira odontológica é importante para controlar os movimentos involuntários e reduzir a dificuldade de deglutição. Recomendações quanto à higiene bucal adequada, alimentação saudável e prevenção de hábitos bucais deletérios são importantes para prevenir o desenvolvimento de doenças bucais. Crianças com problemas de motilidade oral-motora e dificuldades de alimentação devem ser encaminhadas para acompanhamento terapêutico. Devido à presença de distúrbios neuropsicomotores normalmente presentes na Paralisia Cerebral, as crianças afetadas são mais vulneráveis às doenças bucais. Assim, os cuidados com a saúde bucal devem ser realizados o quanto antes pelos pais/responsáveis. Conclusão: Indivíduos com PC apresentam maior risco de desenvolver doenças bucais e programas de saúde bucal iniciados na primeira infância e direcionados às suas especificidades podem ser uma estratégia para minimizar as consequências que possam vir a acontecer.

Nonadherence to treatment protocol for severe hypertension in pregnancy.

BACKGROUND: Hypertensive disorders of pregnancy are one of the leading causes of maternal mortality and severe morbidity. The American College of Obstetricians and Gynecologists recommends treatment of persistent severe hypertension because this has been shown to improve overall outcomes. Treatment remains inconsistent and may be influenced by patient-level sociodemographic and clinical characteristics. OBJECTIVE: This study aimed to identify which factors are associated with nonadherence to an institutional protocol for the treatment of severe hypertension in pregnancy. STUDY DESIGN: Retrospective cohort study of patients who had persistent severe hypertension (≥2 systolic blood pressures ≥160 mm Hg and/or diastolic blood pressures >110 mm Hg between 15 and 60 minutes apart) during their delivery hospitalization in 3 hospitals within an integrated health system from February 1, 2018 to March 1, 2020. Adherence to an institutional protocol was defined as receiving antihypertensive medication within 1 hour of a second severe blood pressure measurement. Demographic information, medical comorbidities, and delivery hospitalization characteristics were compared between women who received treatment based on institutional protocol and those who did not. Patient zone improvement plan codes were linked to neighborhood-level data from the US Census Bureau's American Community Survey to extract socioeconomic characteristics. A multivariable logistic regression was performed to evaluate factors associated with delayed treatment while adjusting for potential confounders. RESULTS: Of the 996 patients included, 449 (45%) received treatment within 60 minutes and 547 (55%) did not. Having an elevated, nonsevere range blood pressure (adjusted odds ratio, 0.55; 95% confidence interval, 0.38-0.79) or a severe range blood pressure (adjusted odds ratio, 0.25; 95% confidence interval, 0.16-0.38) on admission, persistent severe hypertension ≥1 hour before or after delivery (adjusted odds ratio, 0.27; 95% confidence interval, 0.27-0.45), and chronic hypertension (adjusted odds ratio, 0.58; 95% confidence interval, 0.37-0.93) were associated with timely treatment. Hospital site (adjusted odds ratio, 1.97; 95% confidence interval, 1.18-3.28) and increasing gestational age (adjusted odds ratio, 1.14; 95% confidence interval, 1.07-1.21) were associated with nonadherence to treatment protocol. A subanalysis evaluating treatment in 344 (35%) patients who had a nonelevated blood pressure on admission showed that White race, persistent severe hypertension within 1 hour of delivery, increasing gestational age, body mass index, twin gestation, preferred language other than English or Spanish, and a higher neighborhood unemployment rate were associated with nonadherence to treatment protocol. CONCLUSION: Several factors were associated with nonadherence to an institutional protocol for treatment of persistent severe hypertension. Provider bias may impact whether treatment is executed or not. Awareness of these risk factors may improve timely administration of antihypertensive medication in pregnant and postpartum patients.