Clinical Performance of Therapeutic Use of BTX for Bruxism

Mohamed Tahar Maamouri University Hospital

Status: Completed

Conditions: Bruxism; Myofascial Trigger Point Pain; Myofascial Pain Syndrome; Pain

Treatments: Other: Abobotulinumtoxin A injection for bruxism

Study type: Interventional

Funder types: Other

Identifiers

NCT06258070

University hospital Maamouri

Details and patient eligibility

About

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.

Full 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).

Enrollment: 67 patients

Sex: All

Ages: 37 to 61 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Duration of symptoms before BTX injections

Other group

Description:

All the participants received BTX injections. Informed consent was obtained. Doses and sessions of injections varied between them according to the time of recurrence and the duration of the primary symptoms. 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 TrPs detected by carefully palpating the muscle. 0.05 ml was injected into each TrPs.

Treatment:

Other: Abobotulinumtoxin A injection for bruxism