9 research outputs found

    Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

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    Introduction: In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis is suspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCC remains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC. Methods and analysis: This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoint are 3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias. Ethics and dissemination: This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the corresponding author on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals

    Protocol for a multicentre, prospective observational study of elective neck dissection for clinically node-negative oral tongue squamous cell carcinoma (END-TC study)

    Get PDF
    Introduction In early-stage oral tongue squamous cell carcinoma (OTSCC), elective neck dissection (END) is recommended when occult lymph node metastasis issuspected; however, there is no unanimous consensus on the risks and benefits of END in such cases. The management of clinically node-negative (cN0) OTSCCremains controversial. This study, therefore, aimed to evaluate the efficacy of END and its impact on the quality of life (QoL) of patients with cN0 OTSCC.Methods and analysis This is a prospective, multicentre, nonrandomised observational study. The choice of whether to perform END at the same time as resection of the primary tumour is based on institutional policy and patient preference. The primary endpoint of this study is 3-year overall survival. The secondary endpoints are3-year disease-specific survival, 3-year relapse-free survival and the impact on patient QoL. Propensity score-matching analysis will be performed to reduce selection bias.Ethics and dissemination This study was approved by the Clinical Research Review Board of the Nagasaki University. The protocol of this study was registered at the University Hospital Medical Information Network Clinical Trials Registry. The datasets generated during the current study will be available from the correspondingauthor on reasonable request. The results will be disseminated internationally, through scientific and professional conferences and in peer-reviewed medical journals

    Effectiveness of perioperative oral hygiene management using a cetylpyridinium chloride‐, dipotassium glycyrrhizinate, and tranexamic acid‐based mouthwash as an adjunct to mechanical oral hygiene in patients with maxillomandibular fixation: A randomized controlled clinical trial

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    Abstract Objectives Maxillomandibular fixation requires the jawbones to remain static. Mechanical cleaning is also carried out by brushing or with a water flosser to maintain the oral cavity in a hygienic state, but this cannot be considered sufficient. Mouthwashes are used as a substitute for mechanical cleaning or in a supplementary role after such cleaning. The aim is to evaluate the effectiveness of HABITPRO mouthwash, which contains cetylpyridinium chloride, dipotassium glycyrrhizinate, and tranexamic acid in the specific environment created by maxillomandibular fixation used as an adjunct to mechanical cleaning. Material and Methods A total of 55 patients who had undergone maxillomandibular fixation were randomly allocated to either a HABITPRO group (n = 29) or a placebo group (n = 26). To investigate their oral hygiene status, their plaque control record (PCR) was reviewed, and the caries‐related bacterial counts, pH, acid buffering capacity, white blood cell count, and ammonia in saliva were measured immediately before maxillomandibular fixation, on Day 10 of fixation, and immediately after fixation was released. Results After approximately 2–3 weeks of mouthwash use, the PCR index also increased significantly in the placebo group compared with baseline, whereas it remained almost steady in the HABITPRO group. Additionally, salivary ammonia levels decreased significantly in the HABITPRO group compared to that of the placebo group. Conclusions Even with maxillomandibular fixation, continued gargling with HABITPRO mouthwash in the perioperative period as an adjunct to mechanical cleaning can help maintain better oral hygiene and reduce bacterial counts

    Clinical effects of different virtual reality presentation content on anxiety and pain: a randomized controlled trial

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    Abstract Many patients are frightened of or anxious about dental treatment. We have recently reported our use of virtual reality (VR) to alleviate the fear and anxiety experienced during oral surgical procedures However, the effectiveness of VR in alleviating anxiety varies greatly between individuals. We therefore investigated whether the content of the VR presentation made any difference to its effect in alleviating anxiety, and whether it had any analgesic effect. The study subjects experienced one of two different types of VR presentation and were asked to complete a questionnaire about any changes in their anxiety during the procedure, including a visual analog scale (VAS) score. As an objective evaluation, changes in pain threshold during the VR presentation were investigated using PainVision. For those patients who experienced a presentation showing a natural landscape, the change in VAS score was − 13.3 ± 28.7 mm, whereas for those who experienced a presentation showing a video game the change was − 22.2 ± 32.1 mm, an even greater reduction. In a pain questionnaire completed by individuals who had experienced the video game presentations, approximately 70% reported that their pain had diminished. An objective evaluation of pain threshold also showed that the pain threshold of individuals increased by around 3% while experiencing the natural landscape VR presentation, but that while experiencing the video game presentation, it increased significantly by around 15% compared with baseline. These results show that the content of the presentation affected not only the rate of decrease in anxiety, but also the pain threshold

    Erythropoietin receptor signal is crucial for periodontal ligament stem cell-based tissue reconstruction in periodontal disease

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    Abstract Alveolar bone loss caused by periodontal disease eventually leads to tooth loss. Periodontal ligament stem cells (PDLSCs) are the tissue-specific cells for maintaining and repairing the periodontal ligament, cementum, and alveolar bone. Here, we investigated the role of erythropoietin receptor (EPOR), which regulates the microenvironment-modulating function of mesenchymal stem cells, in PDLSC-based periodontal therapy. We isolated PDLSCs from patients with chronic periodontal disease and healthy donors, referred to as PD-PDLSCs and Cont-PDLSCs, respectively. PD-PDLSCs exhibited reduced potency of periodontal tissue regeneration and lower expression of EPOR compared to Cont-PDLSCs. EPOR-silencing suppressed the potency of Cont-PDLSCs mimicking PD-PDLSCs, whereas EPO-mediated EPOR activation rejuvenated the reduced potency of PD-PDLSCs. Furthermore, we locally transplanted EPOR-silenced and EPOR-activated PDLSCs into the gingiva around the teeth of ligament-induced periodontitis model mice and demonstrated that EPOR in PDLSCs participated in the regeneration of the periodontal ligament, cementum, and alveolar bone in the ligated teeth. The EPOR-mediated paracrine function of PDLSCs maintains periodontal immune suppression and bone metabolic balance via osteoclasts and osteoblasts in the periodontitis model mice. Taken together, these results suggest that EPOR signaling is crucial for PDLSC-based periodontal regeneration and paves the way for the development of novel options for periodontal therapy
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