Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Aesyra

Status: Enrolling

Conditions: Sleep Bruxism

Treatments: Device: Biofeedback stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06153810

ABA020-CIP-001

Details and patient eligibility

About

The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 70 years, in good general health.

• Presence of at least one of the following:

  • sleeping partner's report of tooth grinding sounds during sleep for at least three nights per week within the last 6 months,
  • hypertrophy of the masseter muscle upon digital palpation.

• Presence of at least one of the following:

  • signs of tooth attrition or shiny spots on dental restorations,
  • self-report of masticatory muscle fatigue or pain at awakening.

• Previous prescription of a night splint for bruxism.

• Able to understand and follow the protocol and complete the self-administered paper questionnaires.

• Able to provide written informed consent to study participation and storage and processing of study data

Exclusion criteria

• Allergic to Ethylene-Vinyl Acetate (EVA) copolymer.
• With more than two missing molars (excluding third molars).
• Ongoing orthodontic treatment (e.g. teeth alignment).
• With major neurological or psychiatric disorders including substance dependence.
• Using a removable dental prosthesis.
• Using a medication with known effects on sleep or motor behavior.
• Suffering from periodontal disease.
• With occlusal or jaw abnormalities that prevent the wearing of a normal dental splint.
• Participants with pacemakers.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Early stimulation

Experimental group

Description:

Biofeedback treatment is started after two weeks of observation

Treatment:

Device: Biofeedback stimulation

Delayed stimulation

Experimental group

Description:

Biofeedback treatment is started after three weeks of observation

Treatment:

Device: Biofeedback stimulation