Bruxism, Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Pain
Conditions
Keywords
Botulinum toxin, treatment, bruxism, myofascial pain syndrome
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).
Interventions
OTHERAbobotulinumtoxin 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.
Sponsors
Mohamed Tahar Maamouri University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
37 Years to 61 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Tunisia
Outcome results
None listed