Clinical Performance of Therapeutic Use of BTX for Bruxism

Not Applicable

Completed

• Conditions: Myofascial Trigger Point Pain; Myofascial Pain Syndrome; Bruxism; Pain
• Interventions: Other: Abobotulinumtoxin A injection for bruxism

• Registration Number: NCT06258070
• Lead Sponsor: Mohamed Tahar Maamouri University Hospital

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).

Study Timeline

• Study Start: 2009-09-01
• Primary Completion: 2015-12-30
• Study Completion: 2017-12-30
• Study First Submitted: 2024-01-20
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-12
• Last Update Submitted: 2024-02-12
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duration of symptoms before BTX injections	Abobotulinumtoxin A injection for bruxism	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.

Primary Outcome Measures

Name	Time	Method
Correlation between doses of BTX and TrPs	16 to 55 months	The required doses of BTX were compared according to the number of trigger points found in both groups

Secondary Outcome Measures

Name	Time	Method
Comparison of the rate of injection sessions	16 to 55 months	The number of session of BTX injection for complete recovery was studied for both groups.
Correlation of the long standing symptoms and the time to recurrence	16 to 55 months	The time to recurrence was compared between individuals of both groups.

Trial Locations

Locations (1)

Imen Mehri Turki; 🇹🇳 Nabeul, Tunisia