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

• Register: ISRCTN
• Last refreshed on: 3 April 2017
• Main ID: ISRCTN91976427
• Date of registration: 09/03/2017
• Prospective Registration: No
• Primary sponsor: University of Torino
• Public title: Effects on sleep bruxism activity of two different removable oral appliances detected with nocturnal instrumental recordings
• Scientific title: Effects on sleep bruxism activity of functional appliances and occlusal splints detected with nocturnal instrumental ECG/EMG recording: A randomized clinical trial
• Date of first enrolment: 01/05/2014
• Target sample size: 40
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN91976427
• Study type: Interventional
• Study design: Single-centre randomized interventional trial (Treatment)

Countries of recruitment

Italy

Contacts

• Name: Andrea Deregibus

Key inclusion & exclusion 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: 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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Sleep bruxism
Oral Health
Sleep bruxism

Intervention(s)

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 splint appliance (Michigan bite plane) which is a standard acrylic plate. This is worn in the mouth every night for 12 months as per the normal standard of care.

Group 2: Functional appliance group (FA)
Participants in this group are treated with a functional orthopedic appliance. This consists of a palatal button made of acrylic resin and three bites (one anterior and two posteriors) made of resilient stainless steel. This is worn in the mouth every night for 12 months.

Participants in both groups are recorded with multiple nocturnal instrumental electrocardiogram/electromyograms (ECG/EMG) in order to screen and control possible variation in sleep bruxism activity. The participants are given a nighttime recording device and are trained on how to use it and where to put the electrodes. They are provided with written instructions and a night-time telephone number to call in the event of difficulties. The ECG/EMG recordings are conducted with a three channels validate portable device for sleep bruxism diagnosis (Bruxoff ®, OT Bioelettronica, Torino, Italy). Two channels are used to acquire surface electromyography (sEMG) bilaterally from the masseter muscle, and the third channel is used to acquire the electrocardiographic activity (ECG). The three signals are sampled at 800 Hz, with 8 bit resolution. The data is stored on a MicroSD card as a binary file. The sEMG channels are filtered between 10 and 400 Hz with gain 4300. The electrocardiographic (ECG) channel is filtered between 15 and 160 Hz with gain 700. Surface EMGs from the masseter muscle of both sides are detected with disposable bipolar concentric electrodes (Code®, Spes Medica, Battipaglia, Italy), with a radius of 16 mm and with detection site made of AgCl. The heart frequency is detected with a disposable b

Primary Outcome(s)

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

Secondary Outcome(s)

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.

Secondary ID(s)

bitebruxism2016

Source(s) of Monetary Support

Università degli Studi di Torino