Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism (EMG_BRUX)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Suspended

Conditions: Grinding Teeth; Sleep Bruxism; Masseter Muscle Hypertrophy

Treatments: Device: Bruxoff ®

Study type: Interventional

Funder types: Other

Identifiers

NCT06343194

6162

Details and patient eligibility

About

The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.

The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.

The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.

The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Acceptance of the treatment plan with clear aligners;
• Acceptance of informed consent to the study;
• Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine.
• Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health.

Exclusion criteria

• Patients with morphological and structural alterations to the temporomandibular joint, e.g. Condillary hypertrophy;
• Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia;
• Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity;
• Patients with pacemakers;
• Patients with periodontal diseases;
• Patients with ongoing orthodontic therapy or with prosthetic rehabilitation

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

bruxism patients assessed with Bruxoff ®

Active Comparator group

Description:

Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine, i.e. if they have at least one of the following two points: 1. The subject reports or is aware of noises of grinding or clamping during sleep. 2. One or more of the following signs are present: * Abnormal wear of teeth; * Discomfort, fatigue or pain in the muscles of the face; * Hypertrophy of muscles during voluntary clamping; * Any abnormalities in the mandibular muscle activity cannot be expressed by other sleep disorders, medical, neurological, drug use or substance abuse; * Bruxoff ® cut-off more than 4.

Treatment:

Device: Bruxoff ®

non-bruxism patients assessed with Bruxoff ®

Active Comparator group

Description:

Subjects with good health, with no evidence of bruxism symptoms or signs. Bruxoff ® cut-off equal or less than 4.

Treatment:

Device: Bruxoff ®