Viewing Study NCT06343194



Ignite Creation Date: 2024-05-06 @ 8:20 PM
Last Modification Date: 2024-10-26 @ 3:25 PM
Study NCT ID: NCT06343194
Status: RECRUITING
Last Update Posted: 2024-04-11
First Post: 2024-03-26

Brief Title: Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Overview

Official Title: Analysis of Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism Single-centre Interventional Case-control With Device
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EMG_BRUX
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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None