Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

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

Study Overview

• Status: Completed
• Conditions: Sleep Bruxism
• Intervention / Treatment: Device: Biofeedback stimulation

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Monza E Brianza
    • Monza, Monza E Brianza, Italy, 20900
      • Fondazione IRCCS San Gerardo dei Tintori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early stimulation; Biofeedback treatment is started after two weeks of observation	Device: Biofeedback stimulation; Delivery of the vibratory biofeedback stimulus
Experimental: Delayed stimulation; Biofeedback treatment is started after three weeks of observation	Device: Biofeedback stimulation; Delivery of the vibratory biofeedback stimulus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the bruxism activity	Evaluation of the efficacy of AesyBite Active in reducing the bruxism activity expressed as total sleep bruxism duration per hour (TDPH, sec/hour) by at least 60% in the stimulation phase compared with baseline with a 10% non-inferiority margin.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the bruxism index	Evaluation of the efficacy of AesyBite Active in reducing the bruxism index expressed as number of sleep bruxism episodes per hour (episodes/hour).	1 month
Reduction of the mean duration of sleep bruxism episode	Evaluation of the efficacy of AesyBite Active in reducing the mean duration of sleep bruxism episodes (sec/episode).	1 month
Relative change in average intensity of bruxism episodes	A measure of the average bite strength exerted during the bruxism episodes.	1 month
Change in self-reported sleep quality marked on a visual analogue scale	Change in self-reported sleep quality assessed using a visual analogue scale (VAS) with a sleep quality scale from 0 to 10.	1 month
Change in self-reported pain marked on a visual analogue scale	Change in self-reported pain (facial pain, myofascial headache) assessed using a visual analogue scale (VAS) with a pain severity scale from 0 to 10.	1 month
Change in self-reported comfort marked on a visual analogue scale	Change in self-reported comfort assessed using a visual analogue scale (VAS) with a comfort severity scale from 0 to 10.	1 month
Change in self-reported ease of breathing marked on a visual analogue scale	Change in self-reported ease of breathing assessed using a visual analogue scale (VAS) with a ease of breathing severity scale from 0 to 10.	1 month
Change in self-reported retention marked on a visual analogue scale	Change in self-reported retention assessed using a visual analogue scale (VAS) with a retention severity scale from 0 to 10.	1 month

Collaborators and Investigators

• Sponsor: Aesyra SA
• Investigators: Principal Investigator: Marcello Maddalone, Fondazione IRCCS San Gerardo dei Tintori

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Actual): November 7, 2025
• Study Completion (Actual): November 7, 2025

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Mental Disorders; Tooth Diseases; Sleep Wake Disorders; Parasomnias; Bruxism; Sleep Bruxism
• Other Study ID Numbers: ABA020-CIP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No