Bruxism Therapy of Facial Pain (BRUXI)
Effect of Therapy for Myofascial Facial Pain on Bruxism/Nocturnal Clenching. Prospective, Non-profit Interventional Study Using a Device.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Roma
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Roma, Roma, Itálie, 00168
- Nábor
- Clinica Odontostomatologica - Fondazione Policlinico IRCSS A. Gemelli
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Kontakt:
- Prof. Patrizia Gallenzi
- Telefonní číslo: +39 0630156358
- E-mail: patrizia.gallenzi@unicatt.it
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who change their pharmacological regimen during the monitoring period, as drug therapy may affect facial pain and/or muscle activity.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Intervention arm (gnathological occlusal splint)
Adult patients with temporomandibular disorders and chronic myofascial pain of the masticatory muscles treated with a night-time gnathological occlusal splint, with assessment of masticatory muscle electromyographic activity using the dia-BRUXO® device at baseline, after 2 weeks, and after 2 months of splint use. In addition, there is an observational control group consisting of healthy subjects without temporomandibular disorders, included for comparison purposes only and not considered an interventional arm, as no treatment is administered. |
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 occasions during wakefulness (every three hours), their level of facial pain and any awareness of parafunctional activities.
Following the baseline recording, participants will receive the gnathological occlusal splint and will undergo additional 24-hour recordings two weeks after splint delivery and again two months later, for a total of three recordings per participant.
During each recording session, the same self-report measures of facial pain and awareness of parafunctions will be collected.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Bruxism Personal Index (BPI) as Assessed by 24-Hour Electromyography (EMG) in TMD patients
Časové okno: Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.
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The BPI index (n) represents the level of masseter muscle activity recorded continuously over a 24-hour period using the validated portable dia-BRUXO® device.
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Baseline (before splint use), 2 weeks after splint delivery, and 2 months after initiation of treatment.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 7906
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