An interlaboratory study on the detection method for Escherichia albertii in food using real time PCR assay and selective agars.

Escherichia albertii is an emerging enteropathogen. Although E. albertii-specific detection and isolation methods have been developed, their efficiency on food samples have not yet been systematically studied. To establish a series of effective methods for detecting E. albertii in food, an interlaboratory study was conducted in 11 laboratories using enrichment with modified E. coli broth supplemented with cefixime and tellurite (CT-mEC), real-time PCR assay, and plating on four kinds of selective agars. This study focused on the detection efficiency of an E. albertii-specific real-time PCR assay (EA-rtPCR) and plating on deoxycholate hydrogen sulfide lactose agar (DHL), MacConkey agar (MAC), DHL supplemented with rhamnose and xylose (RX-DHL), and MAC supplemented with rhamnose and xylose (RX-MAC). Chicken and bean sprout samples were inoculated with E. albertii either at 17.7 CFU/25 g (low inoculation level) or 88.5 CFU/25 g (high inoculation level), and uninoculated samples were used as controls. The sensitivity of EA-rtPCR was 1.000 for chicken and bean sprout samples inoculated with E. albertii at low and high inoculation levels. The Ct values of bean sprout samples were higher than those of the chicken samples. Analysis of microbial distribution by 16S rRNA gene amplicon sequencing in enriched cultures of bean sprout samples showed that approximately >96 % of the population comprised unidentified genus of family Enterobacteriaceae and genus Acinetobacter in samples which E. albertii was not isolated. The sensitivity of the plating methods for chicken and bean sprout samples inoculated with a high inoculation level of E. albertii was 1.000 and 0.848-0.970, respectively. The sensitivity of the plating methods for chicken and bean sprout samples inoculated with a low inoculation level of E. albertii was 0.939-1.000 and 0.515-0.727, respectively. The E. albertii-positive rate in all colonies isolated in this study was 89-90 % in RX-DHL and RX-MAC, and 64 and 44 % in DHL and MAC, respectively. Therefore, the sensitivity of RX-supplemented agar was higher than that of the agars without these sugars. Using a combination of enrichment in CT-mEC and E. albertii isolation on selective agars supplemented with RX, E. albertii at an inoculation level of over 17.5 CFU/25 g of food was detected with a sensitivity of 1.000 and 0.667-0.727 in chicken and bean sprouts, respectively. Therefore, screening for E. albertii-specific genes using EA-rtPCR followed by isolation with RX-DHL or RX-MAC is an efficient method for E. albertii detection in food.

Medication-related osteonecrosis of the lower jaw without osteolysis on computed tomography images.

INTRODUCTION: Surgery is the standard treatment for medication-related osteonecrosis of the jaw (MRONJ). This study reviewed patients with mandibular MRONJ who underwent surgical treatment, and in particular the characteristics of non-osteolytic MRONJ with no evidence of osteolysis on CT were described. MATERIALS AND METHODS: We conducted a retrospective study of patients with mandibular MRONJ who underwent surgery between January 2016 and September 2022. Various clinical and imaging factors regarding treatment outcomes were investigated and analyzed. Additionally, the disease course of non-osteolytic MRONJ was examined in detail. RESULTS: This study included 55 patients (66 surgeries) with a mean age of 74.7. The primary disease was osteoporosis (24 patients) and malignancy (31 patients); the type of antiresorptive agent was bisphosphonate (BP) in 21 patients and denosumab (DMB) in 26. BP was initially administered; however, it was changed to DMB in eight patients. Preoperatively, the cumulative cure rates for all 66 surgeries were 72.8% at 1 year and 77.3% at 2 years. Cure rates were significantly lower in patients with malignancy, those without osteolysis, and those who underwent sequestrum removal or marginal mandibulectomy than those with osteoporosis, osteolysis, and segmental mandibulectomy. Non-osteolytic MRONJ was observed in eight patients, all with malignancy and receiving high-dose DMB. Only two patients were cured after the initial surgery, and most patients ultimately underwent segmental mandibulectomy. CONCLUSIONS: Surgical treatment yielded good treatment outcomes in most patients with mandibular MRONJ; however, the cure rate was lower in patients with malignancy who showed no osteolysis on CT images.

Efficacy of perioperative oral care management in the prevention of surgical complications in 503 patients after pancreaticoduodenectomy for resectable malignant tumor: A multicenter retrospective analysis using propensity score matching.

BACKGROUND: Pancreaticoduodenectomy has been associated with a high mortality rate and significant postoperative morbidity. Recently, perioperative oral care management has been reported to be effective in preventing postoperative pneumonia and surgical site infection. In this study, we examined the effect of perioperative oral care management in reducing complications after pancreaticoduodenectomy, including surgical site infection. METHODS: This retrospective multicenter study included 503 patients who underwent pancreaticoduodenectomy at 8 facilities between January 2014 and December 2016. Among these, 144 received perioperative oral management by dentists and dental hygienists (oral management group), whereas the remaining 359 did not (control group). The oral care management program included oral health instructions, removal of dental calculus, professional mechanical tooth cleaning, removal of tongue coating, denture cleaning, instructions for gargling, and tooth extraction. The participants were matched using propensity scores to reduce background bias. Various factors were examined for correlation with the development of complications. RESULTS: The incidence of organ/space surgical site infection was significantly lower in the oral management group than in the control group (8.0% vs 19.6%, P = .005). Multivariable logistic regression analysis revealed that hypertension and lack of perioperative oral management were independent risk factors for organ/space surgical site infection. Lack of perioperative oral management had an odds ratio of 2.847 (95% confidence interval 1.335-6.071, P = .007). CONCLUSION: Perioperative oral care management reduces the occurrence of surgical site infections after pancreaticoduodenectomy and should be recommended as a strategy to prevent infections in addition to antibiotic use.

Postoperative hemorrhage after Le Fort I osteotomy hemostasis with angiographic embolization: report of two cases.

This study reported two cases of acute life-threatening hemorrhage after Le Fort I osteotomy. In both cases, computed tomography and angiography revealed damage to the descending palatine artery, which was successfully treated by angiographic embolization. Although massive hemorrhage after Le Fort I osteotomy is rare, acute hemorrhage from the postoperative area may occur. Angiographic embolization is useful in cases of such hemorrhage from the posterior nasal cavity where endoscopic hemostasis is not possible.

Drug holiday of high-dose denosumab and recovery from osteoclast inhibition using immunohistochemical investigation of 7 patients with medication-related osteonecrosis of the jaw undergoing segmental mandibulectomy.

Background/purpose: Denosumab is used to treat bone metastases from malignant tumors. Unlike bisphosphonates, denosumab is not deposited in the bone; thus, withdrawal for a relatively short period would help recovery from osteoclast suppression. This study investigated the relationship between drug holidays and recovery from osteoclast suppression. Materials and methods: Seven patients who received high-dose denosumab and underwent segmental mandibulectomy for medication-related osteonecrosis of the jaw were enrolled in this study. Osteoclast suppression (+) was defined as the absence of cathepsin K-positive cells or cathepsin K-positive mononuclear or small multinucleated cells observed on the bone surface of both mesial and distal specimens. When normal osteoclasts were found, osteoclast suppression was defined as (-); when both suppressed cathepsin K-positive cells and normal morphological osteoclasts were found, it was defined as (±). Results: Osteoclast suppression was: (+) in four patients, three without a drug holiday and one with a 9-month drug holiday; (±) in one patient with an 8-month drug holiday, and (-) in two patients with drug holidays for 13 and 20 months. Conclusion: These findings suggest that a long-term drug holiday, such as 12 months, is required for recovery from osteoclast suppression in patients with cancer receiving high-dose denosumab.

Medication-related osteonecrosis of the jaw without osteolysis on computed tomography: a retrospective and observational study.

Medication-related osteonecrosis of the jaw (MRONJ) is a refractory osteonecrosis caused by antiresorptive agents such as bisphosphonate and denosumab (DMB). In MRONJ surgery, computed tomography (CT) is generally used to determine the extent of bone resection. However, in some recent MRONJ cases, no abnormal findings were detected on CT. Therefore, we aimed to clarify the characteristics of MRONJ without osteolysis. This retrospective and observational study included 18 patients diagnosed with MRONJ between October 2020 and October 2022 at Department of Dentistry and Oral Surgery, Kansai Medical University Medical Center. In four of 18 patients with MRONJ, no abnormal findings such as osteolysis, separation of sequestrum, and periosteal reaction were observed on CT images at the first visit. All four patients with non-osteolytic MRONJ had malignant tumors and received high-dose DMB, and in the four patients there were no preceding dental infections such as apical lesions or periodontal disease and the trigger of MRONJ was unknown. Surgery was performed in three of the four patients. The extent of bone resection was determined using magnetic resonance imaging and intraoperative gross findings. In the future, it is necessary to establish a method for diagnosing non osteolytic MRONJ and determining the extent of bone resection.

Adenoid Ameloblastoma with BRAF p.V600E Mutation Revealing Ameloblastomatous Origin: A First Case Report.

BACKGROUND: Adenoid ameloblastoma (AdAM) is a frequently recurrent tumor that shows hybrid histological features of both ameloblastoma and adenomatoid odontogenic tumor (AOT). AdAM is expected to be classified as a new subtype of ameloblastoma in the next revision of the World Health Organization (WHO) odontogenic tumor classification. However, whether AdAM is a histologic variant of ameloblastoma or AOT remains unclear. To establish a new category, genetic evidence indicating the tumor category is necessary. METHODS: We present a case of a 23-year-old Japanese woman with AdAM who underwent genetic/DNA analysis for ameloblastoma-related mutation using immunohistochemical staining, Sanger sequencing, and next-generation sequencing (NGS) analyses with reliable clinicopathological evidence. RESULTS: Immunohistochemical expression of BRAF p.V600E was diffusely positive for both ameloblastoma- and AOT-like components. Sanger sequencing and NGS analyses showed missense mutations in BRAF p.V600E (c.1799T > A), a gene that is commonly altered in ameloblastomas but not in KRAS, another gene associated with AOT. CONCLUSION: This case report is the first to provide genetic evidence on the ameloblastomatous origin of AdAM with a BRAF p.V600E mutation. A larger series of AdAM groups' molecular testing is needed to aptly classify them and prognosticate the best treatment.

Development of a Novel Real-Time Polymerase Chain Reaction Assay to Detect Escherichia albertii in Chicken Meat.

Escherichia albertii is an emerging enteropathogen. Several foodborne outbreaks of E. albertii have been reported in Japan; however, foods associated with most outbreaks remain unidentified. Therefore, polymerase chain reaction (PCR) assays detecting E. albertii specifically and sensitively are required. Primers and probe for real-time PCR assays targeting E. albertii-specific gene (EA-rtPCR) was designed. With 74 strains, including 43 E. albertii strains and several of its close relatives, EA-rtPCR specifically amplified E. albertii; therefore, the sensitivity of EA-rtPCR was then evaluated. The detection limits were 2.8 and 2.0-3.2 log colony-forming unit (CFU)/mL for E. albertii culture and enriched chicken culture inoculated with the pathogen, respectively. In addition, E. albertii was detected from 25 g of chicken meat inoculated with 0.1 log CFU of the pathogen by EA-rtPCR. The detection of E. albertii from chicken meat by EA-rtPCR was also evaluated by comparing with the nested-PCR assay, and 28 retail chicken meat and 193 dissected body parts from 21 chicken carcass were tested. One and three chicken meat were positive in the nested-PCR assay and EA-rtPCR, respectively. Fourteen carcasses had at least one body part that was positive for EA-rtPCR, and 36 and 48 samples were positive for the nested-PCR assay and EA-rtPCR, respectively. A total of 37 strains of E. albertii were isolated from seven PCR-positive samples obtained from six chicken carcass. All E. albertii isolates harbored eae gene, and were classified as E. albertii O-genotype (EAOg)3 or EAOg4 by EAO-genotyping. The EA-rtPCR developed in this study has potential to improve E. albertii detection in food and advance research on E. albertii infection.

Treatment and Prognosis of Oral Cancer Patients with Confirmed Contralateral Neck Metastasis: A Multicenter Retrospective Analysis.

The prognosis of oral cancer that has metastasized to the contralateral cervical lymph nodes is poor, although the appropriate treatment method has not been established because of its rarity. A multicenter retrospective study on the treatment and prognosis of pN2c oral cancer patients was conducted. We investigated the treatment and prognosis of 62 pN2c patients out of 388 pN+ patients with oral squamous cell carcinomas. Statistical analysis was performed on the various factors with overall survival (OS) and disease specific survival (DSS). In multivariate cox regression analysis, advanced T stage was significantly correlated with poor OS (p = 0.011) and DSS (p = 0.023) of patients with pN2c neck. In pN2c patients, OS, DSS, and neck control was not different between those undergoing ipsilateral neck dissection initially and those undergoing bilateral neck dissection. Thus, contralateral elective neck dissection is not recommended. The most important risk factor for prognosis in pN2c oral cancer patients is advanced T stage. No evidence was found to recommend contralateral elective neck dissection in clinically N1/2b patients. Therefore, the indication for contralateral elective neck dissection in N1/2b patients should be carefully determined in consideration of individual conditions.

Clip Formation in the Complementarity Determining Region of Bevacizumab Lowers Monomer Stability and Affinity for Both FcRn and FcγR: A Comprehensive Characterization of the Clipped Variant Including its Higher Order Structure.

The presence of monoclonal antibody (mAb) fragments in pharmaceutical mAb products is a critical quality attribute and should be controlled for safety. Several mAb fragments derived from clip formation in the complementarity determining regions (CDRs), as well as from cleavage in the hinge region, have been reported. However, the properties of CDR-clipped variants are not fully understood because of difficulties in separating them from intact mAbs under non-denaturing conditions due to similarities in size. We have established a method for separating CDR-clipped variants under non-denaturing conditions using an appropriate size exclusion chromatography column.1 In this report, we provide a comprehensive characterization of a CDR-clipped variant from bevacizumab. The variant exhibited a lower pI, a higher tendency to form dimers, and a lower affinity for both neonatal Fc receptor (FcRn) and Fcγ receptor (FcγR). The effects of clip formation in CDR H3 on the higher order structure were analyzed by hydrogen/deuterium exchange mass spectrometry, and the observed changes in the structures of the VH, CH2, and VL domains were in agreement with the lowered affinity for antigen, FcRn, and FcγR. These findings suggest that clip formation in the CDR may affect the efficacy, safety, and pharmacokinetics of pharmaceutical mAbs.

Factors Exacerbating Clinical Symptoms and CT Findings in Patients with Medication-Related Osteonecrosis of the Jaw Receiving Conservative Therapy: A Multicenter Retrospective Study of 53 Cases.

Recent reports have shown that better treatment outcomes are obtained with surgical therapy in patients with medication-related osteonecrosis of the jaw (MRONJ) than with conservative therapy. However, conservative treatment is selected due to factors such as old age and poor general condition. Conservative therapy aims to relieve symptoms and prevent lesion exacerbation; however, the lesion may expand rapidly in some cases. This study investigated the clinical and imaging findings of 53 MRONJ patients undergoing conservative therapy, and the changes in the clinical findings and the lesion enlargement on CT imaging were examined. Improved clinical findings and no worsening of the imaging findings were considered overall comprehensive treatment successes. Among the 53 patients, the clinical symptoms disappeared or improved in 15 patients, whereas they worsened in 6. In contrast, osteolytic lesion enlargement occurred in 17 patients. The comprehensive treatment outcome of conservative therapy was successful in 12 patients and unsuccessful in 41 patients. The periosteal reaction was significantly correlated with poor comprehensive treatment outcomes (p = 0.038). MRONJ lesions may advance, even if they appear to improve clinically while undergoing conservative treatments. Patients, especially those with periosteal reactions, must be closely followed up with CT examinations, regardless of the clinical findings.

The importance of an eating disorder treatment support center in Japan: A survey from 2017 to 2020.

We investigated the impact of medical collaboration between the Chiba Eating Disorder (ED) Treatment Support Center (CSC) in Chiba Prefecture and the ED treatment center at Kohnodai Hospital. We calculated the number of consultations performed by the CSC and referral rate to other medical facilities from October 2017 to March 2020, as well as the clinical characteristics of the patients treated at our hospital from April 2016 to March 2020. Data on duration of hospitalization and increase in body mass index (BMI) during hospitalization were recorded. Patients were divided into all of the Japan and Chiba Prefecture groups. Data were evaluated by Poisson's regression analysis or one-way analysis of variance. A p-value < 0.05 was considered significant. The 2019 data served as reference values. Our data demonstrated that while the number of CSC consultations increased (2017:201, 2018:547, 2019:552) annually, the number of hospitalizations for EDs decreased (197, 194, 134, respectively). In comparison, the number of outpatient consultations for EDs across all of Japan peaked in 2018 and decreased significantly thereafter (2016:110, 2017:139, 2018:193, 2019:142). After the CSC was established, the number of patients treated in our department decreased as expected. Patients with anorexia nervosa (AN) who were treated on an outpatient basis across all of Japan were younger in 2019 (27.0 ± 1.2) than in 2018 (31.9 ± 1.2). Severe cases had better outcomes, and there was a significant increase in BMI of inpatients with AN in both groups. Overall, the activities of such ED treatment support center promoted successful treatment of severe ED cases.

Number of Bacteria in Saliva in the Perioperative Period and Factors Associated with Increased Numbers.

Perioperative oral management is performed to prevent postoperative complications, but its indication and management method are unclear. This study aimed to investigate salivary bacterial counts pre-and postoperatively, and factors related to increased bacterial count postoperatively. We included 121 patients who underwent surgery under general anesthesia and perioperative oral management. The bacterial count in saliva was determined preoperatively, and first and seventh days postoperatively using the dielectrophoresis and impedance measurement methods. The relationships between salivary bacterial count and various variables were analyzed using one-way analysis of variance, Spearman's rank correlation coefficient, and multiple regression analysis. The salivary bacterial count increased significantly on the first day postoperatively but decreased on the seventh day. Multivariate analysis showed that age (p = 0.004, standardized coefficient ß = 0.283) and xerostomia (p = 0.034, standardized coefficient ß = 0.192) were significantly correlated with increased salivary bacterial count preoperatively. Salivary bacterial count on the day after surgery was significantly increased in patients with a large number of bacterial counts on the day before surgery after preoperative oral care (p = 0.007, standardized coefficient ß = 0.241) and postoperative fasting (p = 0.001, standardized coefficient ß = -0.329). Establishing good oral hygiene before surgery and decreasing salivary bacterial count are necessary in patients with a high risk of postoperative surgical site infection or pneumonia, especially in older adults or postoperative fasting.

Risk factors for osteoradionecrosis of the jaw in patients with oral or oropharyngeal cancer: Verification of the effect of tooth extraction before radiotherapy using propensity score matching analysis.

Background/purpose: Osteoradionecrosis of the jaw (ORN) often occurs in patients with head and neck cancer undergoing radiotherapy (RT). It has been recommended to extract the tooth before RT that may become source of infection, but in recent years, some investigators have reported that tooth extraction before RT increase the risk of developing ORN and therefore should be avoided. The purpose of the study is to evaluate the risk factors for ORN including tooth extraction before RT. Materials and methods: This was a retrospective study of 366 patients with oral or oropharyngeal cancer who underwent RT of 50 Gy or more at six university hospitals, with follow-up of at least six months post-RT. The relationship between each factor and ORN incidence was analyzed using the Cox proportional hazard model. Results: Periapical lesions, more than 50% loss of alveolar bone, and tooth extraction after RT significantly correlated with ORN. Intensity-modulated RT showed a lower incidence than three-dimensional conformal RT, although not statistically different. Tooth extraction before RT significantly reduced ORN incidence, after adjusting the background factors using propensity score matching. Conclusion: In patients with oral or oropharyngeal cancer who underwent RT, periapical lesions, more than 50% loss of alveolar bone, and tooth extraction after RT significantly increased the risk for ORN. Infected tooth extraction before RT significantly reduced the risk.

Effect of decreased tongue pressure on dysphagia and survival rate in elderly people requiring long-term care.

Background/purpose: Tongue pressure plays an important role in swallowing function. The purpose of this study is to investigate whether decreased tongue pressure is associated with dysphagia and the development of pneumonia in the elderly requiring long-term care. Materials and methods: Tongue pressure measurement and swallowing videoendoscopic (VE) examination were performed in 60 hospitalized elderly people (33 males and 27 females, with an average age of 84.3 years) to investigate the relationship with the clinical course. Factors related with dysphagia was analyzed by Fisher's exact test and one-way ANOVA, followed by multivariate logistic regression. The relationship between each variable and survival were analyzed by cox regression. Results: Twenty-one patients had dysphagia by VE examination. Multivariate analysis showed that smaller BMI and reduced tongue pressure were significantly correlated with dysphagia. Smaller number of remaining teeth and dysphagia were significantly related to pneumonia-related death. No patients with tongue pressure of larger than 20 kpa died by pneumonia within one year, while in those with tongue pressure of smaller than 20 kpa, one-year cumulative survival rate by pneumonia was 44.3%. Conclusion: Decreased tongue pressure was significantly associated with dysphagia and may increase the risk of pneumonia-related death in the elderly requiring long-term care.

Structural basis for proteolytic processing of Aspergillus sojae α-glucosidase L with strong transglucosylation activity.

An α-glucosidase from Aspergillus sojae, AsojAgdL, exhibits strong transglucosylation activity to produce α-1,6-glucosidic linkages. The most remarkable structural feature of AsojAgdL is that residues 457-560 of AsojAgdL (designated the NC sequence) is not conserved in other glycoside hydrolase family 31 enzymes, and part of this NC sequence is proteolytically cleaved during its maturation. In this study, the enzyme was expressed in Pichia pastoris, and electrophoretic analysis indicated that the recombinant enzyme, rAsojAgdL, consisted of two polypeptide chains, as observed in the case of the enzyme produced in an Aspergillus strain. The crystal structure of rAsojAgdL was determined in complex with the substrate analog trehalose. Electron density corresponding to residues 496-515 of the NC sequence was not seen, and there were no α-helices or ß-strands except for a short α-helix in the structures of residues 457-495 and residues 516-560, both of which belong to the NC sequence. The residues 457-495 and the residues 516-560 both formed extra components of the catalytic domain. The residues 457-495 constituted the entrance of the catalytic pocket of rAsojAgdL, and Gly467, Asp468, Pro469, and Pro470 in the NC sequence were located within 4 Å of Trp400, a key residue involved in binding of the substrate. The results suggest that the proteolytic processing of the NC sequence is related to the formation of the catalytic pocket of AsojAgdL.

Relationship between Drug Holidays of Antiresorptive Agents and Surgical Outcomes in Cancer Patients with Medication-Related Osteonecrosis of the Jaw.

It is controversial as to whether the withdrawal of antiresorptive (AR) agents is necessary while treating medication-related osteonecrosis of the jaw (MRONJ). In this study, we investigated whether a drug holiday promoted sequestrum separation and improved the surgical outcomes of MRONJ patients with malignant tumors, who were undergoing high-dose AR therapy. In total, we included 103 MRONJ patients with malignant tumors as their primary disease who underwent surgery at Nagasaki University Hospital or Kansai Medical University Hospital from January 2009 to December 2020. We recorded the patients' age, sex, primary disease, MRONJ stage, type and administration period of the AR agent, presence of diabetes, corticosteroid use, drug holiday period, white blood cell count, serum albumin, serum creatinine, outcomes, and computed tomography findings. The relationships between a drug holiday and sequestrum separation, and between a drug holiday and outcome, were analyzed. Drug holidays of 60, 90, and 120 days were not significant factors of sequestrum separation and did not influence patients' surgical outcomes as per the univariate and multivariate analyses. MRONJ patients with cancer as their primary disease should be operated upon immediately and without drug holidays if their general condition permits surgery.

Intraoperative alteration in the vital signs of diabetic patients during cataract surgery with local anesthesia.

PURPOSE: Diabetic patients often have systemic circulation diseases which may cause serious systemic complications during ophthalmic surgeries with local anesthesia. The purpose of this study is to evaluate the intraoperative alteration of the vital signs in diabetic patients during cataract surgery with local anesthesia. METHODS: Clinical records of 428 patients who underwent cataract surgeries with local anesthesia were reviewed. The parameters measured were systolic/diastolic blood pressures and pulse rates at pre-operation, 5, 10 and 15 minutes during the surgeries. The factors were compared between non-diabetic patients (n = 325) and diabetic patients (n = 103). RESULTS: Diabetic patients had significantly higher fasting blood sugar and preoperative pulse rate. Diabetic patients showed significantly higher systolic blood pressure compared to non-diabetic patients at 5 and 10 minutes from the beginning of surgery (p = 0.0093 and 0.0075, respectively). In the non-diabetic patients, the pulse rate was significantly decreased at 5 minutes from the beginning of surgery (p = 4.74 x 10-8) which was maintained during the surgery, but no change was observed in the pulse rate of the diabetic patients. CONCLUSIONS: Diabetic patients showed higher systolic blood pressure and pulse rate during cataract surgeries with local anesthesia, which should be monitored carefully by the physicians to avoid possible systemic complications.

Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study).

INTRODUCTION: This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in patients with head and neck cancer undergoing concomitant radiotherapy with cisplatin or cetuximab. METHODS AND ANALYSIS: The trial will take place at seven hospitals in Japan. Patients will be randomised (1:1) into betamethasone and control groups after the occurrence of grade 1 oral mucositis. In the betamethasone group, patients will use betamethasone valerate ointment five times a day, in addition to usual oral hygiene guidance. The primary endpoint is the incidence and onset time of grade 3 oral mucositis. The secondary endpoints are the incidence and onset time of grade 2 oral mucositis, incidence and onset time of oral candidiasis, completion of radiation therapy and adverse events. Target accrual is 102 patients with a two-sided type I error rate of 5% and 80% power to detect an 80% risk reduction in the incidence of grade 3 oral mucositis. ETHICS AND DISSEMINATION: This study was approved by the Clinical Research Review Board of Nagasaki University (No. CRB20-009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publication. The datasets generated during the study will be available from the corresponding author on reasonable request. TRIAL REGISTRATION NUMBER: jRCTs071200013.

Association between dental extraction after radiotherapy and osteoradionecrosis: A multi-centre retrospective study.

OBJECTIVE: Radiotherapy (RT) carries a substantial risk for the development of osteoradionecrosis (ORN) of the jaw. This study was performed to investigate the relationship between dental extractions after RT and the development of ORN. MATERIAL AND METHODS: Thirty-two patients with head and neck cancer who underwent tooth extraction after RT were investigated for correlations between the development of ORN and various factors. RESULTS: Postextraction ORN was diagnosed in 12 (12.1%) teeth of 9 patients. The RT dose against the site of tooth extraction was 62.0 and 37.4 Gy in the ORN and Non-ORN groups, respectively (p < .001). The duration from RT to tooth extraction was 41.2 and 28.2 months in the ORN and Non-ORN groups, respectively (p = .025). Tooth extraction was significantly associated with ORN in patients with a high RT dose against the site (odds ratio = 1.231) and a longer duration of time from RT (odds ratio = 1.084). CONCLUSIONS: Extraction of non-restorable teeth and those with a poor prognosis should not necessarily be postponed even when patients are undergoing RT. However, clinicians should pay special attention to postoperative management after tooth extraction in patients with a high RT dose and longer time from RT.