Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722809
Status:
TERMINATED
Last Update Posted:
2022-05-26
First Post:
2021-01-20
Brief Title:
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Difficulties in recruiting patients compounded by problems extracting data from the device used in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Botox
Brief Summary:
Bruxism is defined as a parafunction that consists of a clenching of the jaw andor grinding of the teeth It can occur when an individual is sleeping or awake or it can be mixed
Most often it is primary or idiopathic bruxism however when it is related to a cause it is qualified as secondary
Primary bruxism is a condition that is not well known to the general public but I is very widespread 12 of the adult population In addition it can alter quality of life as a result of associated sleep disorders concentration disorders daytime fatigue chronic pain etc
The current treatment for this condition is only symptomatic Currently one of the most effective treatments is the intramuscular injection of botulinum toxin A in the muscles of mastication The progressive anticholinergic action results in a reduction of functional signs dental pain periodontal pain temporomandibular joint pain tension headaches neck pain and physical signs reduction of the mass of the injected muscles alba linea tongue scalloping limitation or stability of dental damage
However these clinical data are practically not objectified in daily practice Objective criteria would make it possible to measure the effectiveness of the treatment to follow the patient and to identify the early symptoms in order to prevent a recurrence
The aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection
Most often it is primary or idiopathic bruxism however when it is related to a cause it is qualified as secondary
Primary bruxism is a condition that is not well known to the general public but I is very widespread 12 of the adult population In addition it can alter quality of life as a result of associated sleep disorders concentration disorders daytime fatigue chronic pain etc
The current treatment for this condition is only symptomatic Currently one of the most effective treatments is the intramuscular injection of botulinum toxin A in the muscles of mastication The progressive anticholinergic action results in a reduction of functional signs dental pain periodontal pain temporomandibular joint pain tension headaches neck pain and physical signs reduction of the mass of the injected muscles alba linea tongue scalloping limitation or stability of dental damage
However these clinical data are practically not objectified in daily practice Objective criteria would make it possible to measure the effectiveness of the treatment to follow the patient and to identify the early symptoms in order to prevent a recurrence
The aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None