NCT06343194

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

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: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	Bruxoff ®	Bruxoff ® is a holter that measures the masseter muscle contraction and heart rate.

Timeline

• Start date: 2025-10-31
• Primary completion: 2027-10-31
• Completion: 2027-12-31
• First posted: 2024-04-02
• Last updated: 2025-08-27

Locations

1 site across 1 country: Italy