Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Sleep Bruxism Clinical Trial

Official title:

Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153810
• Other study ID #: ABA020-CIP-001
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2023
• Source: Aesyra SA
• Contact: Marco Letizia
• Phone: +390282396887
• Email: marco.letizia[@]aesyra.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism

Intervention

Device:
• Biofeedback stimulation
Delivery of the vibratory biofeedback stimulus

Locations

Country	Name	City	State
Italy	Fondazione Irccs San Gerardo Dei Tintori	Monza	Monza E Brianza (MB)

Sponsors (1)

Lead Sponsor	Collaborator
Aesyra SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Relative change in average intensity of bruxism episodes	A measure of the average bite strength exerted during the bruxism episodes.	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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