NCT06258070

Clinical Performance of Therapeutic Use of BTX for Bruxism

Clinical Performance of Therapeutic Use of Botulinum Toxin in the Treatment of Bruxism: A Retrospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Mohamed Tahar Maamouri University Hospital · Academic / Other
• Sex: All
• Age: 37 Years – 61 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Myofascial Pain Syndrome
• Myofascial Trigger Point Pain
• Bruxism
• Pain

Interventions

Type	Name	Description
OTHER	Abobotulinumtoxin A injection for bruxism	Trigger points were detected with careful palpating of the masticatory muscles (masseter and temporalis muscles) of patients suffering from bruxism. Each trigger point received 0,05 lm ol reconstituted solution of Abobotulinumtoxin A. Dysport (Ipsen Pharma, Germany) was reconstituted with 0.9% sodium chloride solution so that 0.1 ml corresponded to 25 U.

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-12-30
• Completion: 2017-12-30
• First posted: 2024-02-14
• Last updated: 2024-02-14

Locations

1 site across 1 country: Tunisia