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

NCT06343194 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-27

No results posted yet for this study

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

Interventions

DEVICE

Bruxoff ®

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

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Massimo Cordaro, professor · UOC Odontoiatria Generale e Ortodonzia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343194 on ClinicalTrials.gov