Tokyo, Nov. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059918) titled 'Comparison of the effect of three types of oral appliance during experimental bruxism on the masseter muscle' on Nov. 28.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Tokyo Dental College

Condition: Condition - Bruxism Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to clarify the differences in physiological effects of two types of jaw movements-clenching and grinding-performed experimentally during wakefulness in healthy adults, focusing on tissue oxygenation of the masticatory muscles, muscle fatigue, and autonomic nervous system activity. Furthermore, by combining three types of oral appliances (hard-type, soft-type, and combi-type) with a non-appliance condition, this study aims to examine how these appliances influence physiological responses under each condition and to compare subjective evaluations, thereby elucidating the effects of oral appliance use on the body and the differences arising from material characteristics. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Healthy adult participants perform experimental jaw-movement tasks in a laboratory setting. Under four oral appliance conditions (no appliance, hard-type appliance, soft-type appliance and combi-type appliance) applied in random order, each participant performs clenching and grinding tasks. In the clenching task, participants are instructed to perform maximal voluntary clenching for 30 seconds. In the grinding task, they perform maximal voluntary grinding at 1 Hz for 30 seconds. Near-infrared spectroscopy of the masseter muscles (tissue oxygenation), surface electromyography and heart rate variability are recorded during the 4-minute pre-task baseline, the 30-second task period and the 4-minute post-task recovery period. Immediately after each task, subjective fatigue and appliance-related evaluations are assessed using a visual analogue scale. All tasks are completed in a single visit with sufficient rest periods between tasks. This study employs a within-subjects (cross-over) design in which all participants complete all four conditions (no appliance, hard-type, soft-type, and combi-type). Although the order of conditions is randomized for each participant, there is no group allocation; therefore, the study is registered as "non-randomized" in the UMIN system.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Healthy adults Having at least 28 teeth No subjective or objective abnormalities in the oral cavity, temporomandibular joint, or craniocervical muscles No history of neurosurgical diseases Key exclusion criteria - Taking medications that may affect psychological or cardiovascular systems Having signs or symptoms of temporomandibular disorders (TMD) in screening tests History of neurosurgical diseases Considered unsuitable for participation by the investigators Target Size - 18

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2020 Year 09 Month 01 Day Date of IRB - 2016 Year 10 Month 18 Day Anticipated trial start date - 2020 Year 10 Month 01 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068477

Disclaimer: Curated by HT Syndication.