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

Not Applicable

Suspended

• Conditions: Sleep Bruxism; Masseter Muscle Hypertrophy; Grinding Teeth

• Registration Number: NCT06343194
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-02
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-26
• Last Update Posted: 2025-08-27
• Study Start: 2025-10-31
• Primary Completion: 2027-10-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in potentials recorded by Bruxoff ® in bruxism patients.	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.	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).

Secondary Outcome Measures

Name	Time	Method
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.	The secondary outcome consists in the mutation of signs (i.e. tooth wear) and symptoms (i.e. massetere muscles pain) of bruxism.; In order to evaluate how occlusal relationships have changed in bruxism patients treated with aligners at the three study times (T0, T1, T2), we compare their clinical condition with non-bruxism patients.; Furthermore, it's possible to measure the following characteristics during the three study times (T0, T1, and T2), both in the individual group and between patients with and without bruxism, using the Visual Analogue Scale (range 0-10): * the mutation of the chewing muscles' pain and of the related migraines; * the variation of the functional limitation during routine mandibular movements related to treatment with clear aligners.

Trial Locations

Locations (1)

UOC Clinica Odontoiatrica, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore; 🇮🇹 Rome, Lazio, Italy