Clinical trial NCT06258070: Clinical Performance of Therapeutic Use of BTX for Bruxism
Official title: Clinical Performance of Therapeutic Use of Botulinum Toxin in the Treatment of Bruxism: A Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Myofascial Trigger Point Pain
Bruxism
Pain
Keywords: Botulinum toxin
treatment
bruxism
myofascial pain syndrome
Lead sponsor: Mohamed Tahar Maamouri University Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 67
Sex: ALL
Minimum age (years): 37
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A retrospective cohort study of two samples of participants ( group with long-standing for more than one year, group with recent symptoms for less than one year), with a single-arm trial (all the participants had the same treatment).
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the performance of botulinum toxin (BTX) injections for bruxism. Participants were divided into two groups according to the duration of the symptoms. The main question is whether BTX should be reserved for long-standing bruxism where the conventional methods failed or indicated as a first-line treatment. The investigator also compared the required doses and the frequency of treatment sessions between these two groups for a complete recovery.

Detailed description: The effectiveness of botulinum toxin (BTX) in treating bruxism is recognized and well-established. This study aims to provide the most suitable condition for a better performance of BTX injections.

This retrospective study of a single-arm trial was conducted using a medical database of 67 patients who suffered from bruxism between 2009 and 2015, and who had total recovery after injection sessions. Patients were divided into two groups based on the duration of their bruxism. The main outcomes measured were: pain relief, the total number of injection sessions until total recovery, doses of BTX used, and recovery duration between two consecutive sessions. The treatment was stopped when bruxism disappeared.

The investigator carried out injections using Dysport (Ipsen Pharma, Germany). The toxin was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U. The patient received the same doses in each session, delivered to trigger points (TrPs). 0.05 ml was injected into each TrP.

The level of statistical significance was set at p \< 0,01. The Chi-square test and ANOVA table were used to compare differences according to injection sessions, doses of BTX, TrPs, and recovery duration between the two groups (with long-standing bruxism, and recent bruxism).

Eligibility criteria: Inclusion Criteria:

* Patients who self-reported having awake bruxism and recovered completely following BTX injections during the period ranging between 2009 and 2015. It includes patients who had previously occlusal splints and who should stop their use once the BTX injections were started.

Exclusion Criteria:

* Patients suffering from temporomandibular disorders or having a contraindication to BTX injection.

Primary outcomes:
measure: Correlation between doses of BTX and TrPs
timeFrame: 16 to 55 months
Secondary outcomes:
measure: Comparison of the rate of injection sessions
timeFrame: 16 to 55 months
measure: Correlation of the long standing symptoms and the time to recurrence
timeFrame: 16 to 55 months
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: Imen Mehri Turki
Study officials:
affiliation: University hospital Mohamed Tahar Maamouri. Nabeul, Tunisia
name: Imen Mehri Turki, Dr
role: PRINCIPAL_INVESTIGATOR
References: