Assessment of space changes in the lower dental arch after the premature unit loss of a primary molar: A randomized clinical trial.

BACKGROUND: Premature loss of primary teeth presents a significant challenge in oral health, with conflicting views on using space maintainers. AIM: To assess mandibular arch space changes associated with premature lower primary molar (PM) loss with or without a space maintainer. DESIGN: A randomized clinical trial with children (6-9 years old) with premature loss of a lower PM divided into two groups: control group (CG), without a space maintainer, and intervention group (IG), with a space maintainer. Dental casts were measured at baseline, 3 months, and 6 months. Linear distance; intercanine width and length; and arch width, length, and perimeter were measured. ANOVA and t-test were applied (p = .05). RESULTS: Twenty-six patients (mean: 7.3 years; standard deviation [SD]: 0.92) were included: 14 in CG and 12 in IG. CG had a greater space loss (-0.9 mm; SD: 0.45) than IG (-0.4 mm; SD: 0.61) at 3 months (p < .05). No difference between the groups was observed after 6 months (p = .610). CG decreases space at 6 months, especially with the first permanent molars without intercuspation (-2 mm; SD: 0.71; p = .007). CONCLUSION: Premature lower PM loss resulted in reduced arch space loss after 6 months, regardless of a space maintainer use. CG showed more loss of space when the first permanent molars lacked intercuspal relationship.

Clinical performance of posterior restorations using a universal adhesive over moist and dry dentin: A 36-month double-blind split-mouth randomized clinical trial.

OBJECTIVES: To evaluate the influence of dentin moisture on the clinical behavior of a universal adhesive on posterior teeth after 36 months of follow-up. METHODS: Forty-five patients participated in this study. Following a split-mouth design, three operators placed 90 Class I/Class II restorations over moist dentin (MD) or dry (DD) (n = 45) with resin composite (Filtek Bulk Fill) and a universal adhesive used in the etch-and-rinse mode (Single Bond Universal). Each restoration was evaluated according to the FDI and USPHS criteria (postoperative sensitivity, fracture and retention, marginal staining, marginal adaptation, and recurrence of caries) at baseline and after 6-, 12-, and 36 months. For statistical analysis, Kruskal Wallis analysis of variance rank (α = 0.05) and Kaplan-Meier survival analysis were used. RESULTS: No significant difference between groups was observed in each FDI criterion after 36 months of clinical evaluation (p > 0.05). The retention rates (confidence interval 95 %) were 97.37 % (86.5 - 99.5) for both MD and DD without significant difference between them (p > 0.05). Eight restorations (MD = 4; DD = 4) showed minimal marginal staining defects (p > 0.05). Two restorations were lost (MD = 1; DD = 1). Fifteen restorations (MD = 8; DD = 7) presented minor marginal discrepancies according to the FDI criteria (p > 0.05). CONCLUSION: The clinical performance of the universal adhesive when applied in etch-and-rinse mode was not influenced by dentin moisture in posterior bulk-fill composite restorations. CLINICAL SIGNIFICANCE: The level of dentin moisture appears not to influence the clinical efficacy of a universal adhesive when applied using the etch-and-rinse technique in posterior composite resin restorations.

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial.

BACKGROUND: Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm's canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma. METHODS: This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days. DISCUSSION: Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients' quality of life. TRIAL REGISTRATION: Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y . Registered on July 29, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.

Selective outcome reporting in randomized clinical trials using the third molar surgery model.

Selective outcome reporting (SOR) can threaten the validity of results found in clinical trials. Some studies in the literature have analyzed SOR in dentistry, but there is no study that has observed SOR in clinical trials in oral and maxillofacial surgery. Impacted third molar surgery is one of the most used models in clinical trials to study mainly analgesic and anti-inflammatory drug interventions. Our study aimed to evaluate the prevalence of SOR in publications employing the third molar extraction clinical trial model, and to verify whether there was an association between the statistical significance of outcomes and other characteristics that could lead to SOR. A systematic search was performed on the ClinicialTrials.gov platform for randomized clinical trial protocols, using the condition of third molar extraction. The corresponding published articles were sourced in PubMed, Scopus, and Embase databases, and compared with the registered protocols regarding the methodological data, in terms of: sample calculation, primary outcome identification, end-point periods, insertion of new outcomes in the publication, and results of outcomes. 358 protocol records were retrieved; 87 presented their corresponding articles. SOR was identified in 28.74% of the publications, and had a significant relationship with changes in the protocol, insertions of new outcomes, and discrepancies in the types of study. General risk of bias was found to be low. There were associations between SOR and the discrepancies in terms of the type of study, the choice of new outcome, and changes in the history of protocol records. The prevalence of SOR in clinical research using the third molar extraction surgery model is moderate. The quality of the scientific reporting of the results and, consequently, the certainty of evidence relating to the intervention tested can be overstated, increasing the chances of misinterpretation by health professionals.

Motor Effects of Intervention With Transcranial Direct Current Stimulation for Physiotherapy Treatment in Children With Cerebral Palsy: Protocol for a Randomized Clinical Trial.

BACKGROUND: Children diagnosed with cerebral palsy (CP) often experience various limitations, particularly in gross motor function and activities of daily living. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that has been used to improve movement, gross motor function, and activities of daily living. OBJECTIVE: This study aims to evaluate the potential additional effects of physiotherapy combined with tDCS in children with CP in comparison with physiotherapy only. METHODS: This is a 2-arm randomized controlled trial that will compare the effects of tDCS as an adjunctive treatment during rehabilitation sessions to rehabilitation without tDCS. Children with CP classified by the Gross Motor Function Classification System as levels I and II will be randomly assigned to either the sham + rehabilitation group or the tDCS + rehabilitation group. The primary outcome will be the motor skills assessed using the Gross Motor Function Measure domain E scores, and the secondary outcome will be the measurement scores of the children's quality of life. The intervention will consist of a 10-day stimulation protocol with tDCS spread over 2 weeks, with stimulation or sham tDCS administered for 20 minutes at a frequency of 1 Hz, in combination with physiotherapy. Physical therapy exercises will be conducted in a circuit based on each child's baseline Gross Motor Function Measure results. The participants' changes will be evaluated and compared in both groups. Intervenient features will be tested. RESULTS: Data collection is ongoing and is expected to be completed by January 2025. A homogeneous sample and clear outcomes may be a highlight of this protocol, which may allow us to understand the potential use of tDCS and for whom it should or should not be used. CONCLUSIONS: A study with good evidence and clear outcomes in children with CP might open an avenue for the potential best use of neurostimulation. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials RBR-104h4s4y; https://tinyurl.com/47r3x2e4. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/52922.

Pre-incisional local infiltration with levobupivacaine in laparoscopic cholecystectomy: a randomized and clinical trial.

OBJECTIVE: Laparoscopic cholecystectomy (LC), despite its minimally invasive nature, requires effective control of post-operative pain. The use of local anesthetics (LA) has been studied, but the level of evidence is low, and there is little information on important parameters such as health-related quality of life (HRQoL) or return to work. The objective of the study was to evaluate the efficacy of 0.50% levobupivacaine infiltration of incisional sites in reducing POP after LC. METHODS: This was a prospective, randomized, double-blind study. Patients undergoing elective LC were randomized into two groups: no infiltration (control group) and port infiltration (intervention group). POP intensity (numerical rating scale, NRS), need for rescue with opioid drugs, PONV incidence, HRQoL, and return to work data, among others, were studied. RESULTS: Two hundred and twelve patients were randomized and analyzed: 105 (control group) and 107 (intervention group). A significant difference was observed in the NRS values (control group mean NRS score: 3.41 ± 1.82 vs. 2.56 ± 1.96) (p < 0.05) and in the incidence of PONV (31.4% vs. 19.6%) (p = 0.049). CONCLUSIONS: Levobupivacaine infiltration is safe and effective in reducing POP, although this does not lead to a shorter hospital stay and does not influence HRQoL, return to work, or overall patient satisfaction.

OBJETIVO: la colecistectomía laparoscópica (CL), a pesar de su carácter mínimamente invasivo, requiere un control efectivo del dolor postoperatorio (POP). El uso de anestésicos locales (AL) ha sido estudiado pero el nivel de evidencia es bajo y existe poca información acerca de parámetros relevantes como la calidad de vida relacionada con la salud (CVRS) o la reincorporación laboral. El objetivo de este estudio es analizar la eficacia de la infiltración de los sitios incisionales con levobupivacaína 0,50% en la reducción del dolor postoperatorio tras la CL. MATERIAL Y MÉTODOS: estudio prospectivo, aleatorizado y doble ciego. Pacientes sometidos a CL programada fueron aleatorizados en dos grupos: sin infiltración (grupo control) y con infiltración preincisional (grupo intervención). La intensidad del dolor (escala de puntuación numérica, NRS), la necesidad de rescates con opioides, la incidencia de náuseas o vómitos postoperatorios (NVPO) y datos de CVRS o reincorporación laboral, entre otros, fueron recogidos. RESULTADOS: 212 pacientes fueron aleatorizados y analizados: 105 en el grupo control y 107 en el grupo de intervención. Se observó una diferencia estadísticamente significativa en la intensidad del dolor (puntuación media NRS: 3.41 ± 1.82 vs. 2.56 ± 1.96) (p < 0.05) y en la incidencia de NVPO (31.4% vs. 19.6%) (p = 0.049). CONCLUSIONES: La infiltración con levobupivacaína es segura y efectiva en la reducción del dolor postoperatorio, aunque esto no conlleva una menor estancia hospitalaria y no influye en los resultados de CVRS, reincorporación laboral o satisfacción del paciente.

Effect of the type of application tip for 35% hydrogen peroxide on bleaching efficacy and tooth sensitivity: A randomized clinical trial.

OBJECTIVES: Evaluate the bleaching efficacy (BE) and tooth sensitivity (TS) of in-office bleaching using different application tips. METHODS: Forty-eight participants were selected (split-mouth), one to receive bleaching with an attached brush tip and one with a conventional tip. The procedure was performed with Whiteness Automixx Plus 35%. The BE was evaluated at the beginning, weekly, one and 12 months post-bleaching with a Vita Easyshade spectrophotometer (ΔE*ab, ΔE00, and WID) and with Vita classical A1-D4 and Vita Bleachedguide shade guides units (ΔSGU). Absolute risk and intensity of TS were recorded using the Visual Analogue Scale. The equivalence of BE was analyzed using the two one-sided t-tests for paired samples. The absolute risk of TS was evaluated using the McNemar test, and the TS intensity was measured with the paired t test (α = 0.05). RESULTS: The equivalence of BE was observed for both groups in all color evaluations (p > 0.05). A lower absolute risk and intensity of TS were observed for the attached brush tip when compared with the conventional tip (p < 0.003 and p < 0.0001). CONCLUSION: Using an attached brush tip showed the same BE as a conventional tip. However, for the attached brush tip, there was a reduction in TS. CLINICAL SIGNIFICANCE: The applicator-attached brush tip is recommended for in-office dental bleaching, because of the possible reduction in risk and intensity of TS.

Impact of multiple-session home-based transcranial direct current stimulation (M-HB-tDCS) on eating behavior in fibromyalgia: A factorial randomized clinical trial.

BACKGROUND: Multiple-session home-based self-applied transcranial direct current stimulation (M-HB-self-applied-tDCS) has previously been found to effectively reduce chronic pain and enhance cognitive function. However, the effectiveness of this method for disordered eating behavior still needs to be studied. OBJECTIVE: This study aimed to assess whether 20 sessions of M-HB-self-applied-tDCS, administered over four weeks to either the left dorsolateral prefrontal cortex (L-DLPFC) or primary motor cortex (M1), could improve various aspects of eating behavior, anthropometric measures, and adherence. METHODS: We randomly assigned 102 fibromyalgia patients between the ages of 30 and 65 to one of four tDCS groups: L-DLPFC (anodal-(a)-tDCS, n = 34; sham-(s)-tDCS, n = 17) or M1 (a-tDCS, n = 34; s-tDCS, n = 17). Patients self-administered 20-min tDCS sessions daily with 2 mA under remote supervision following in-person training. RESULTS: Generalized linear models revealed significant effects of M-HB-self-applied-tDCS compared to s-tDCS on uncontrolled eating (UE) (Wald χ2 = 5.62; df = 1; P = 0.018; effect size, ES = 0.55), and food craving (Wald χ2 = 5.62; df = 1; P = 0.018; ES = 0.57). Regarding fibromyalgia symptoms, we found a differentiated impact of a-tDCS on M1 compared to DLPFC in reducing food cravings. Additionally, M-HB-a-tDCS significantly reduced emotional eating and waist size. In contrast, M1 stimulation was more effective in improving fibromyalgia symptoms. The global adherence rate was high, at 88.94%. CONCLUSION: These findings demonstrate that M-HB-self-applied-tDCS is a suitable approach for reducing uncontrolled and emotional eating, with greater efficacy in L-DLPFC. Furthermore, these results revealed the influence of fibromyalgia symptoms on M-HB-self-applied-tDCS's, with M1 being particularly effective in mitigating food cravings and reducing fibromyalgia symptoms.

Treatment stability with bonded versus vacuum-formed retainers after 12 months: A randomized clinical trial.

OBJECTIVE: To compare the clinical effectiveness of V-bend bonded retainers (BR) versus vacuum-formed retainers (VFR) regarding their capacity to maintain treatment stability and survival rates after 12 months. MATERIALS AND METHODS: Patients finishing orthodontic treatment were randomly allocated into two groups. The BR group received maxillary and mandibular BRs in the lingual surfaces of the anterior teeth. The VFR group received VFRs right after fixed appliances removal. The patients were evaluated at four time-points: at fixed appliances removal (T0), after 3 (T1), 6 (T2) and 12 months (T3). In each time-point digital models were obtained and analysed with the OrthoAnalyzer™ software. Treatment stability based on occlusal outcomes and retainers' survival rates were evaluated. Intergroup comparisons were performed using Mann-Whitney U-tests. The Kaplan-Meier survival plot and the log-rank test were employed to assess the retainers' survival. RESULTS: Both BR and VFR groups included 25 patients. The groups were comparable regarding their baseline characteristics. Up to 6 months, both retainers were equally effective; however, after 12 months, BRs were more effective in maintaining the incisors' alignment in the maxilla and the mandible compared to the VFRs. No differences were noticed in the intercanine and intermolar widths, overjet and overbite. There were no differences regarding the retainers' survivability in both arches. CONCLUSIONS: BRs were more effective in maintaining the alignment of the incisors in the maxilla and mandible compared to VFRs after 12 months. Both retainers presented the same survival rates after the same period.

Effect of two irrigating solutions on antimicrobial activity and clinical and radiographic success after endodontic treatment in primary teeth: a randomized clinical trial.

OBJECTIVES: This study evaluated the antimicrobial activity, clinical and radiographic outcome of pulpectomy in primary teeth using either 1% sodium hypochlorite (NaOCl) or 2% chlorhexidine (CHX) as irrigants. MATERIALS AND METHODS: A randomized double-blind controlled clinical study in which primary teeth were allocated to 1% NaOCl (n = 20) and 2% CHX (n = 20) groups. Microbiological collections were performed before and after irrigation for agar culture and real-time polymerase chain reaction (qPCR). Clinical and radiographic success was assessed at different times. Data were submitted to descriptive analysis, chi-square, Mann-Whitney, and Wilcoxon tests (p  < .05). RESULTS: For 1% NaOCl, the following clinical and radiographic success rates were observed: 7 days (93%/80%); 30 days, 3 and 6 months (100%). For 2% CHX: 7 days (73%/53%); 30 days (93%); 3 months (100%/93%); 6 months (100%) (p > .05). One percent NaOCl and 2% CHX effectively reduced total microorganisms (p < .05) but not mutans streptococci (p > .05). In qPCR analysis, the solutions promoted a reduction of total bacteria and Streptococcus mutans, and no difference was observed between times and groups (p > .05). CONCLUSIONS: One percent NaOCl and 2% CHX were effective for clinical and radiographic success and antimicrobial activity in primary teeth submitted to pulpectomy. CLINICAL RELEVANCE: Studying the antimicrobial activity and clinical and radiographic outcomes of pulpectomy in primary teeth using NaOCl and CHX as irrigants is clinically relevant because it provides information for optimizing treatment protocols and improving the quality of care for pediatric patients. It contributes to evidence-based practice and can potentially lead to better outcomes, reduced complications, and enhanced patient experiences.

Clinical outcomes following atrophic alveolar ridge reconstruction using collagenated xenogeneic bone block or autogenous bone block: One-year follow-up of a randomized controlled clinical.

AIM: This investigation aimed to evaluate the 1-year survival of implants placed after staged lateral alveolar ridge augmentation using equine-derived collagenated xenogeneic bone blocks (CXBBs) or autogenous bone block (ABB). MATERIALS AND METHODS: Fifty patients who underwent lateral augmentation in a previous trial were included. The primary outcome measure was implant survival at the 1-year follow-up, and secondary outcomes included implant success, peri-implant clinical and volumetric parameters, pink aesthetic scores (PES) and patient-reported outcome measures. Data analysis involved Fisher's exact test, the Mann-Whitney U-test and the Wilcoxon signed-rank test. RESULTS: In this study, no late implant failures were observed. The cumulative survival rates were 78.6% for the CXBB group and 90.9% for the ABB group, with no difference between the groups. Similarly, the success rates were 53.6% and 63.6%, respectively, showing no significant difference. Peri-implant clinical and volumetric parameters indicated the presence of healthy peri-implant tissues surrounding implants placed in both CXBB- and ABB-augmented sites. PES were 8.5 and 11.0 for implants placed in CXBB- and ABB-augmented sites, respectively. Furthermore, patient satisfaction rates were high and similar between the groups. CONCLUSIONS: Dental implants placed in both CXBB- and ABB-augmented ridges demonstrated no statistically significant differences in clinical, volumetric and aesthetic outcomes, along with high patient satisfaction rates.

Efficacy of different in-office treatments for dentin hypersensitivity: randomized and parallel clinical trial

Abstract The aim of this clinical, prospective, randomized, and parallel study was to evaluate different in-office treatments for dentin hypersensitivity (DH). One hundred ninety-two teeth with non-cavitated root exposures were treated using different desensitizers: fluoride varnish (Duraphat - FLU); bioactive ceramic solution (Biosilicate - BIOS); universal self-etching adhesive (Single Bond Universal - SBU); bioactive photoactivated varnish (PRG filler - SPRG). The degree of DH was analyzed using a visual analog scale (VAS) and computerized visual scale (CoVAS), before treatments and after 7, 15, and 30 days from the first session. Comparisons among desensitizers were performed using the Kruskal-Wallis and Dunn's tests. Friedman test was used to compare between times (p ≤ 0.05). Comparing desensitizers FLU presented a higher value of DH than BIOS using VAS at 7 days, however, no differences were found using CoVAS analysis. Comparing times, BIOS and SBU showed a reduction in DH after 7 days and SBU showed a reduction at 30 days compared to 7 days using VAS. FLU and SPRG groups reduced DH from 15 days to 30 days using VAS. There was a reduction in DH for FLU, BIOS, and SBU after 7 days and for BIOS this reduction also occurred at 30 days when compared to 15 days using CoVAS. SPRG group showed a reduction from 15 to 30 days. All desensitizers tested were able to reduce the initial sensitivity. The bioactive ceramic solution reduced the DH gradually after 30 days using computerized analysis.

Resumo O objetivo deste estudo clínico, prospectivo, randomizado e paralelo foi avaliar diferentes tratamentos em consultório para hipersensibilidade dentinária (HD). Cento e noventa e dois dentes com exposições radiculares não cavitadas foram tratados com diferentes dessensibilizantes: verniz fluoretado (Duraphat - FLU); solução cerâmica bioativa (Biosilicato - BIOS); adesivo autocondicionante universal (Single Bond Universal - SBU); verniz fotoativado bioativo (PRG filler - SPRG). O grau de HD foi analisado por meio da escala visual analógica (VAS) e da escala visual computadorizada (CoVAS), antes dos tratamentos e após 7, 15 e 30 dias da primeira sessão. As comparações entre dessensibilizantes foram feitas pelos testes de Kruskal-Wallis e Dunn. O teste de Friedman foi utilizado para comparação entre os tempos (p ≤ 0,05). Comparando os dessensibilizantes, o FLU apresentou um valor de HD maior do que o BIOS usando VAS aos 7 dias, no entanto, nenhuma diferença foi encontrada usando a análise CoVAS. Comparando os tempos, BIOS e SBU apresentaram redução de HD após 7 dias e SBU apresentou redução aos 30 dias em comparação com 7 dias usando VAS. Os grupos FLU e SPRG reduziram a HD em 15 dias a 30 dias usando VAS. Houve redução de HD para FLU, BIOS e SBU após 7 dias e para BIOS essa redução também ocorreu aos 30 dias quando comparada a 15 dias usando CoVAS. O grupo SPRG apresentou redução de 15 para 30 dias. Todos os dessensibilizantes testados foram capazes de reduzir a sensibilidade inicial. A solução de cerâmica bioativa reduziu o HD gradualmente após 30 dias usando análise computadorizada.

Perceived dyspnea and experience of hospitalized patients with acute decompensated heart failure undergoing an early MObilization protocol with immersive Virtual rEality: MOVE study protocol for a parallel superiority randomized clinical trial.

BACKGROUND: Immersive virtual reality (VR) is an innovative strategy for inpatient rehabilitation programs. Using immersive VR in early mobilization protocols has not yet been investigated in the setting of hospitalized patients with acute decompensated heart failure (ADHF), especially to improve perceived dyspnea, a common symptom of heart failure (HF). METHODS: This is a single-center parallel superiority randomized clinical trial. The study will be conducted at a public teaching hospital in Brazil from January 2023 to January 2024. The sample will include adult patients with ADHF hospitalized for at least 24 h, randomly assigned in a 1:1 ratio to the control (standard early mobilization protocol conducted in the intensive care unit (ICU)) or intervention group (the same standard early mobilization protocol but associated with immersive VR). The primary outcome will be assessing perceived dyspnea, and the secondary outcome will be assessing patient experience. DISCUSSION: Using immersive VR in early mobilization protocols in the ICU is expected to improve perceived dyspnea in patients with ADHF as well as patient experience regarding care. This study has the potential to increase patient adherence to early mobilization protocols in the setting of ADHF as well as to promote a positive patient experience. Filling this gap could promote the rational incorporation of technologies in health care. TRIAL REGISTRATION: This study protocol is in its first version. CLINICALTRIALS: gov NCT05596292. Registered on 1 December 2022.

Efficacy of an environmental enrichment intervention for endometriosis: a pilot study.

Introduction: We have previously shown that Environmental Enrichment (EE), a multi-modal psychosocial intervention consisting of increased social interaction, novelty, and open spaces, improved disease presentation, anxiety, and immune-related disturbances in the rat model of endometriosis. However, there is a knowledge gap regarding the effects of EE interventions in patients with this painful, inflammatory chronic disease. Aim: To adapt and test the efficacy of an EE intervention on pelvic pain, mental health, perceived stress, quality of life, and systemic inflammation in endometriosis patients through a randomized clinical trial (RCT). Materials and methods: A multidisciplinary team with expertise in physiology, neuroscience, psychology, and women's health adapted and implemented a two-arm RCT comparing an EE intervention with a wait-list control group. Six EE modules administered on alternate weeks were provided to patients in the intervention (N = 29); controls received education only. Survey data and biospecimens were collected at baseline, end-of-study, and 3-months post-intervention to assess pain (Brief Pain Inventory, BPI), endometriosis-related quality of life-QoL (Endometriosis Health Profile-30, EHP30), anxiety (Generalized Anxiety Disorder 7, GAD7), depression (Patient Health Questionnaire for Depression 8, PHQ8), pain catastrophizing (Pain Catastrophizing Score, PCS), stress (Perceived Stress Scale-14, PSS14), and saliva cortisol levels (AM, PM). Results: Compared to the wait-list controls, participants in the EE intervention showed significantly decreased GAD-7 scores at the end of the intervention and 3-month follow-up. Depression, perceived stress, and QoL improved at the 3-month follow-up compared to baseline. While pain levels did not improve, they significantly correlated with anxiety, depression, QoL and pain catastrophizing scores. Conclusion: This pilot RCT demonstrated significant improvements in anxiety and depressive symptoms, QoL, and perceived stress, supporting enriched environments as an integrative psychosocial intervention to be used as adjuvant to the standard of care for endometriosis pain.

Incidence of Bacteriobilia and the Correlation with Antibioticoprophylaxis in Low-Risk Patients Submitted to Elective Videolaparoscopic Cholecystectomy: A Randomized Clinical Trial.

Cholelithiasis has a major impact on global health and affects an average of 20% of the Western population. The main risk factors are females, age over 40 years, obesity and pregnancy. Most of the time it is asymptomatic, but when there are symptoms, they are generally nonspecific. Bile was considered sterile, but today it is known that it contains a complex bacterial flora, which causes biofilm in the gallbladder and gallstones. Among the main bacteria associated with cholelithiasis are Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, species of Enterococcus spp. and Acinetobacter spp. Antibiotic prophylaxis is used in an attempt to reduce postoperative infections, especially at the surgical site. However, some authors found no relationship between the use of antibiotic prophylaxis and a lower risk of surgical site infection. Thus, the aim of this double-blind randomized clinical trial was to compare the existence or not of bacteriobilia in patients at low anesthetic risk who underwent videolaparoscopic cholecystectomy, and its correlation with the use of prophylactic antibiotics. This study included 40 patients between 18 and 65 years old, diagnosed with cholelithiasis, symptomatic or not, with low anesthetic risk classified by the American Society of Anesthesiology in ASA I or ASA II, without complications or previous manipulation of the bile duct, who underwent elective video cholecystectomy, divided into two groups: Experimental Group A (n = 20), which received 2 g of Cephalotin (first-generation Cephalosporin, Keflin®, ABL antibiotics, Cosmópolis, Brazil) during anesthetic induction, and Control Group B (n = 20), where no antibiotics were administered until bile collection. After the procedure, a bile sample was collected and culture and antibiogram were performed. In the sample, 22 (55%) were classified as ASA I and 18 (45%) as ASA II. It was observed that 81.8% of the patients who had a positive culture did not use antibiotics, against 18.2% of those who used prophylaxis. When comparing patients regarding anesthetic risk, ASA I patients had a positive culture in 9.1% of cases, against 90.9% in patients classified as ASA II. It was concluded that patients with higher anesthetic risk (ASA II) have a higher chance of bacteriobilia and benefit from antibiotic prophylaxis when compared to patients with lower anesthetic risk (ASA I).

Deficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review.

Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.

Healthcare Workers (HCWs) and non-HCWs reaction to Bacillus Calmette-Guérin (BCG) in the BATTLE trial.

OBJECTIVES: Healthcare workers (HCWs) may have different response to Bacillus Calmette-Guérin (BCG) vaccination due to previous occupational exposure to Mycobacterium particles. We report subgroup analysis of the BATTLE trial, comparing BCG effects in HCWs vs non-HCWs. This was a secondary analysis of a trial. METHODS: The BATTLE trial was a double-blind placebo-controlled phase III clinical trial that investigated BCG revaccinating adults who were recently infected with SARS-CoV-2 virus. BCG and placebo recipients were sub-grouped based on regular occupational contact with patients into HCWs (48 BCG and 50 placebo) and non-HCWs (124 BCG and 134 placebo). Weekly COVID-19 symptom progression and injection site reactions were compared between subgroups on weeks one, two, three, and six follow-ups. RESULTS: HCWs were more likely to complain of itching on the injection site early after injection (OR = 2.5, p = 0.049). They developed peeling and crusting on the site of injection faster than non-HCWs (during the second week, p = 0.033 and 0.040, OR = 3.3 and 2.7, respectively). HCWs were also more likely to maintain their papule or develop a late onset pustule during later weeks (weeks four and six, p = 0.024 and 0.006, OR = 2.2 and 8.6, respectively). In terms of COVID-19 symptom progression, recovery from anosmia was more likely in the non-HCWs who received BCG (week six, pHolm's corrected = 0.002, OR = 3.3). CONCLUSION: HCWs' local reaction to BCG injection was slightly more rapid and more intense, possibly due to their occupational exposure. BCG may also ameliorate COVID-19 induced inflammation and anosmia in non-HCWs but not HCWs. Therefore, HCWs might be less likely to benefit from BCG vaccination. CLINICALTRIALS: gov register number NCT04369794.

Risk of bias in dentistry-related randomized controlled trials in spanish language journals

Objectives: To assess the risk of bias (RoB) of randomized controlled trials (RCTs) published in dental journals in the Spanish language. Methods: A systematic retrospective survey was conducted of all RCTs published from 1980 to 2019 in dentistry Spanish and Latin American journals. We extracted data and performed RoB assessments using the Cochrane Risk of Bias tool. Results: 292 RCTs published in 51 journals were included. The best-rated domains were incomplete outcome data, selective reporting, and other biases. The domains assessed with higher proportions of an unclear or high risk of bias were sequence generation, allocation concealment, and blinding of outcome assessment. There is a low proportion of RCTs published in Spanish language journals. However, the number has been increasing over the years, and the low risk of bias assessment rates across domains show an increasing trend. Conclusions: A low percentage of Spanish-language dental journals issue RCTs. Our assessment of these RCTs' RoB suggests higher difficulties in the design and conduction phase than in the posterior reporting stage.

Choking, gagging and complementary feeding methods in the first year of life: a randomized clinical trial.

OBJECTIVE: Compare the occurrence of choking and gagging in infants subjected to three complementary feeding (CF) methods. METHODS: Randomized clinical trial with mother-infant pairs, allocated according to the following methods of CF: a) Parent-Led Weaning (PLW) - group control, b) Baby-Led Introduction to SolidS (BLISS), and c) mixed (initially BLISS and if the infant presents a lack of interest or dissatisfaction, PLW), with the last two methods guided by the infant. Mothers received nutritional intervention on CF and prevention of choking and gagging according to the method at 5.5 months of age and remained in follow-up until 12 months. Frequencies of choking and gagging were collected by questionnaire at nine and 12 months. The comparison between groups was performed using the analysis of variance test (p < 0.05). RESULTS: 130 infants were followed, and 34 (26.2%) children presented choking between six and 12 months of age, 13 (30.2%) in PLW, 10 (22.2%) BLISS, and 11 (26.2%) mixed method, no significative difference between methods (p > 0.05). The choking was caused mainly by the semi-solid/solid consistency. Moreover, 100 (80%) infants aged from six to 12 months presented gagging and their characteristics were not statistically different among groups (p > 0.05). CONCLUSION: Infants following a baby-led feeding method that includes advice on minimizing choking risk do not seem more likely to choke than infants following traditional feeding practice that includes advice on minimizing choking risk.