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

NCT06343194 | Suspended

• 1 other identifier: 6162
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Bruxism; Masseter Muscle Hypertrophy; Grinding Teeth

Keywords

clear aligners; bruxoff; electromiograph; therapy; masseter muscle contraction; muscle pain

Outcome Measures

Primary Outcomes (1)

• Change in potentials recorded by Bruxoff ® in bruxism patients.

  The primary outcome of the study is the change in potential recorded by Bruxoff®, defined as the variation in nocturnal masseter contraction activity just in bruxism patients treated with aligners.The study aims to evaluate and compare diagnostic records measured with the Bruxoff® at three time points. Each time, the Bruxoff® is used two nights in a row. The purpose of the first night's data collection is to help the patient learn how to apply and use the device to its fullest potential; only the data collected on the second night will be used in the study to determine whether or not the patient has bruxism. * The Bruxoff® device is initially administered for two consecutive nights before the start of aligner therapy (T0). * 2 months after starting clear aligner therapy (T1), Bruxoff® is given for two consecutive nights. * The last 2 records are registered 6 months after the beginning of the treatment with clear aligners (T2).

  The records with Bruxoff® device are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.

Secondary Outcomes (1)

• Change of signs and symptoms of bruxism

  The clinical examinations are made: before the beginning of the treatment with clear aligner (T0), after 2 months (T1) and after 6 months (T2) from the start of the therapy.

Study Arms (2)

bruxism patients assessed with Bruxoff ®

ACTIVE COMPARATOR

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.

Device: Bruxoff ®

non-bruxism patients assessed with Bruxoff ®

ACTIVE COMPARATOR

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

Device: Bruxoff ®

Interventions

Bruxoff ® DEVICE

Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.

bruxism patients assessed with Bruxoff ®; non-bruxism patients assessed with Bruxoff ®

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

UOC Clinica Odontoiatrica, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

Location

Related Publications (28)

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  PMID: 18557915 RESULT

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MeSH Terms

Conditions

Sleep Bruxism; Masticatory Muscles, Hypertrophy of; Bruxism; Myalgia

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Massimo Cordaro, professor

  UOC Odontoiatria Generale e Ortodonzia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: bruxism patients and non-bruxism patients

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: October 31, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

IT (1)