Interest of the BRUXENSE Occlusal Splints for Bruxism Diagnosis: a Feasibility Study

Not Applicable

Completed

• Conditions: Bruxism, Sleep-Related
• Interventions: Device: BRUXENSE occlusal splint

• Registration Number: NCT03363204
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

There is no accurate diagnosis method for bruxism for now. Consequences of bruxism over teeth, muscles and articulation of the jaw are important.

This study aims to develop a innovative tool in order to accurately rapidly diagnose bruxism in ambulatory evaluation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-06
• Study Start: 2018-02-08
• Primary Completion: 2018-12-28
• Study Completion: 2018-12-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• adult from 18-70

• patients diagnosed with bruxism according to the following criteria:

• positive question at one of the following question:

  • are you aware of your grinding?
  • does your partner hear you grinding?
  • are you aware that you are frequently tighten your jaws during the day and/or the night?
  • are you tired and/or do experience jaws 'muscular pain in the morning.

• presence of at least one criteria:

  • abnormal tooth wear or tooth prosthesis damages
  • Hypertrophy of the masseter muscles

• patients agreeing to participate

• patient able to understand and follow the protocol

• patient with health insurance

Read More

Exclusion Criteria

• patients with more than 2 missing tooth
• Severe troubles to correctly close the mouth.
• neurological disorder (Parkinson, Alzheimer) or psychiatric disorder
• Sleep disorder (insomnia, narcolepsy, sleep apnea, restless leg disorder)
• use of drugs that potentially impair sleep (benzodiazepines, neuroleptics, tricyclic antidepressants) alcohol or narcotics.
• complete or partial removal dental prosthesis or orthodontic device
• Patient under legal protection
• pregnant women
• Patients deprived of their freedom by a judicial or administrative decision

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BRUXENSE	BRUXENSE occlusal splint	Patients corresponding to selection criteria will use the BRUXENSE occlusal splint for 10 consecutive nights.

Primary Outcome Measures

Name	Time	Method
Patient rate with successful use of BRUXENSE occlusal splint	At day 10	The BRUXENSE occlusal splints correct use in real situation will be evaluated by measuring the percentage of subjects able to use this occlusal splints during 10 consecutive nights (6 hours minimum) without any pain or any discomfort. 10 nights is the necessary delay to record sufficient data to make a diagnosis.

Secondary Outcome Measures

Name	Time	Method
Satisfaction scale score	At day 10	Subject satisfaction will be assessed thanks to a numeric scale going from 0 (not satisfied at all) to 10 (completely satisfied)
Proportion of patients diagnosed with bruxism	At day 10	Proportion of patients diagnosed with bruxism according to the BRUXENSE occlusal splints after the analysis of the data collected during 10 days.
Number of usable measurements	At day 10	The quality of collected data will be determined by the number of measurements that can be used to make a diagnosis of bruxism after 10 consecutive nights

Trial Locations

Locations (1)

Service de Consultations et de Traitements Dentaires, Hospices Civils de Lyon; 🇫🇷 Lyon, France