Clinical Performance of Therapeutic Use of BTX for Bruxism

Pain Clinical Trial

— BTX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06258070
• Other study ID #: University hospital Maamouri
• Status: Completed
• Phase: N/A
• Start date: September 1, 2009
• Est. completion date: December 30, 2017

Study information

• Verified date: February 2024
• Source: Mohamed Tahar Maamouri University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 37 Years to 61 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Myofascial Trigger Point Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Imen Mehri Turki	Nabeul

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Tahar Maamouri University Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between doses of BTX and TrPs	The required doses of BTX were compared according to the number of trigger points found in both groups	16 to 55 months
Secondary	Comparison of the rate of injection sessions	The number of session of BTX injection for complete recovery was studied for both groups.	16 to 55 months
Secondary	Correlation of the long standing symptoms and the time to recurrence	The time to recurrence was compared between individuals of both groups.	16 to 55 months