Dental splint effect in bruxism (condition where a person grinds, clenches, or gnashes their teeth, either while awake or asleep)

Electromiographic evaluation of masseter muscle activity before and after wearing an occlusal appliance for sleep bruxism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80828502

Enrollment

Registered

2024-10-10

Start date

2022-10-01

Completion date

Unknown

Last updated

2024-10-28

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

Conditions

Bruxism (sleep/awake) Mental and Behavioural Disorders

Interventions

The randomization process was conducted by computer, assigning a number to each potential participant from a larger group of students with sleep bruxism. This randomization occurred in the initial pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age over 18 years 2. Subjects with self-reported bruxism 3. Subject with changes in the dentition (presence of cracks, dental wear) 4. Subject willing to wear the dental splint 5. Subjects with good oral hygiene

Exclusion criteria

Exclusion criteria: 1. Systemic diseases 2. Subjects wearing an orthodontic appliance 3. Subjects diagnosed with sleep apnoea 4. Subjects with sleep bruxism treated with medication 5. Subjects wearing a dental splint already

Design outcomes

Primary

Measure	Time frame
1. Change in sleep bruxism activity is measured using surface electromyography (sEMG) at baseline and after 3 months 2. Comparison of sleep bruxism activity between low and moderate sleep bruxism groups is measured using surface electromyography (sEMG) at baseline and after 3 months 3. Change in awake bruxism indexes is measured using sEMG device software at baseline and after 3 months 4. Comparison of awake bruxism indexes between low and moderate sleep bruxism groups is measured using sEMG device software at baseline and after 3 months	—

Measure

Time frame

1. Change in sleep bruxism activity is measured using surface electromyography (sEMG) at baseline and after 3 months 2. Comparison of sleep bruxism activity between low and moderate sleep bruxism groups is measured using surface electromyography (sEMG) at baseline and after 3 months 3. Change in awake bruxism indexes is measured using sEMG device software at baseline and after 3 months 4. Comparison of awake bruxism indexes between low and moderate sleep bruxism groups is measured using sEMG device software at baseline and after 3 months

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Romania

Contacts

Public ContactAdrian Marcel Popescu

sanda.popescu@umfcv.ro+44 722248030

Outcome results

None listed

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