Effects on sleep bruxism activity of two different removable oral appliances detected with nocturnal instrumental recordings

Effects on sleep bruxism activity of functional appliances and occlusal splints detected with nocturnal instrumental ECG/EMG recording: A randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91976427

Enrollment

Registered

2017-03-09

Start date

2014-05-01

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep bruxism Oral Health Sleep bruxism

Interventions

Participants are randomly allocated to one of two groups using a random number list software generator. Group 1: Occlusal splint group (OS) Participants in this group are treated with an occlusal s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Able to give informed consent 2. Suffering from sleep bruxism 3. Good oral hygiene and periodantal status 4. No extended dental restorations

Exclusion criteria

Exclusion criteria: 1. Neurological diseases 2. Signs/symptoms of tempormandibular disorders 3. Already wearing occlusal splints 4. Post traumatic patients 5. Suffering from other sleep disorders (i.e. sleep apnea, restless leg syndrome)

Design outcomes

Primary

Measure	Time frame
Sleep bruxism index is measured using the Bruxmeter software at baseline, 1, 3, 6, and 12 months.	—

Secondary

Measure	Time frame
Identification of variations in sleep bruxism index and/or in specific EMG signals (tonic, phasic or mixed) measured using from Bruxmeter software at baseline, 1, 3, 6, and 12 months.	—

Countries

Italy

Contacts

Public ContactAndrea Deregibus

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026