Идёт набор NCT07611643

Bruxism Therapy of Facial Pain

Без фазы С лечением Bruxism Bruxism, Sleep-Related Sleep Quality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy)..
Кому может быть актуально: Состояния в реестре: Bruxism, Bruxism, Sleep-Related, Sleep Quality. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Therapy for Myofascial Facial Pain on Bruxism/Nocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.

Обзор

This prospective, non-profit study aims to better understand how occlusal splints (gnathological splints) affect daytime and nighttime bruxism (teeth grinding) and clenching in adults with chronic myofascial pain of the jaw muscles, a common form of temporomandibular disorder (TMD). Bruxism and clenching are repetitive or sustained jaw muscle activities that can contribute to jaw pain and dysfunction, and their accurate diagnosis requires instrumental assessment of muscle activity. In this study, muscle activity will be objectively measured using a portable device (dia-BRUXO®) worn for 24 hours, which records the electrical activity of the chewing muscles during both wakefulness and sleep. Adult patients with TMD who are prescribed a night-time occlusal splint will undergo three 24-hour recordings: before using the splint, two weeks after starting treatment, and two months later. During each recording, participants will also report their facial pain levels and awareness of clenching or grinding during the day. Their results will be compared with those of a matched control group without TMD. The main goal is to compare jaw muscle activity between patients and healthy individuals, while secondary goals include analyzing how long the muscles are active and how these patterns relate to symptoms. By combining objective measurements and patient-reported experiences, this study seeks to clarify how occlusal splints influence muscle activity and symptoms, helping clinicians improve diagnosis and treatment of bruxism and TMD.

Подробное описание

This prospective, non-profit interventional study is designed to evaluate the effects of a gnathological occlusal splint on masticatory muscle activity in adults with temporomandibular disorders (TMD) and chronic myofascial pain. Bruxism and clenching, occurring during both wakefulness and sleep, are recognized contributors to TMD symptoms and are best assessed through instrumental measurement. For this purpose, the study uses a validated portable device (dia-BRUXO®) capable of recording the electromyographic (EMG) activity of the masseter muscles continuously over a 24-hour period, allowing objective assessment of muscle activity during daily life and sleep.

Participants with TMD who have a clinical indication for nocturnal occlusal splint therapy will undergo three 24-hour EMG recordings: at baseline (before splint use), two weeks after splint delivery, and two months after initiation of treatment. During each recording period, participants will also self-report facial pain intensity and awareness of parafunctional activities at regular intervals during wakefulness. EMG outcomes will include average signal amplitude, muscle activation time, and the presence of abnormal co-contraction patterns. These data will be used to assess changes in muscle activity over time and in relation to splint use.

A control group of age- and sex-matched adults without TMD will undergo two 24-hour EMG recordings, two months apart, following the same recording and self-report procedures. Comparisons between the TMD group and controls will allow identification of functional differences in masticatory muscle activity. The primary endpoint is the comparison of masseter muscle EMG activity between participants with TMD and healthy controls, while secondary endpoints include analysis of muscle activation duration and correlations between EMG patterns and reported symptoms. This integrated approach aims to improve understanding of the functional impact of occlusal splints and support more objective diagnosis and management of bruxism and TMD.

Вмешательства

Устройство Electromyographic analysis of the masseter muscle using the Diabruxo® device (Biotech-Novations, Sanremo, Italy).
Enrolled participants will be adults with chronic myofascial pain of the masticatory muscles who have a clinical indication for nocturnal treatment with a gnathological occlusal splint. Patients who agree to undergo this therapy for their initial diagnosis will be invited to participate in the study. After providing written informed consent, participants will be given the Diabruxo® device and instructed to perform a 24-hour recording. During device use, patients will be asked to record, on five

Первичные конечные точки

Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients [Срок оценки: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.]

Критерии участия

Критерии включения

Adult subjects aged ≥ 18 years
Subjects willing to provide written informed consent
Patients with temporomandibular disorders who have an indication for treatment with a gnathological occlusal splint