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

August 26, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Analysis of Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism: Single-centre Interventional Case-control With Device

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • UOC Clinica Odontoiatrica, Policlinico Agostino Gemelli Università Cattolica del Sacro Cuore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: bruxism patients assessed with Bruxoff ®

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 ®
Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.
Active Comparator: non-bruxism patients assessed with Bruxoff ®
Subjects with good health, with no evidence of bruxism symptoms or signs. Bruxoff ® cut-off equal or less than 4.
Device: Bruxoff ®
Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in potentials recorded by Bruxoff ® in bruxism patients.
Time Frame: 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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of signs and symptoms of bruxism
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Massimo Cordaro, professor, UOC Odontoiatria Generale e Ortodonzia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6162

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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