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ID07611643

Study of Night-Time Occlusal Splint Therapy on Jaw Muscle Activity and Pain in Adults with Temporomandibular Disorders

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2026-06-17

42

Participants Needed

1

Research Sites

31 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying adults with chronic myofascial pain in the jaw muscles, a common type of temporomandibular disorder TMD, to understand how occlusal splints affect daytime and nighttime teeth grinding and clenching. This prospective, non-profit interventional study compares jaw muscle activity in patients using a night-time gnathological occlusal splint with a matched control group without TMD. The study uses a device to measure muscle electrical activity objectively during daily life and sleep. Participants with TMD who are prescribed a night-time splint will wear a portable electromyographic device for 24 hours at three time points before starting splint use, two weeks after receiving the splint, and two months later. During each recording, they will report facial pain levels and awareness of jaw clenching or grinding. The control group will undergo two 24-hour recordings two months apart without receiving treatment. The study focuses on comparing muscle activity between groups and analyzing the duration and patterns of muscle activation related to symptoms. Participants will be monitored closely using the dia-BRUXO device and self-reported pain and clenching awareness during wakefulness. The main outcome measured is the Bruxism Personal Index BPI assessed by 24-hour electromyography at baseline, two weeks, and two months after treatment starts. Researchers aim to improve diagnosis and management of bruxism and TMD by combining objective muscle activity data with patient experiences. The study will last until early 2027, with multiple assessments over two months for each participant.

CONDITIONS

Brief Title

Bruxism Therapy of Facial Pain

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