Clinical Performance of Therapeutic Use of BTX for Bruxism
Condition: Myofascial Pain Syndrome; Myofascial Trigger Point Pain; Bruxism; Pain
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Bruxism
Study type: Interventional

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).
    

Intervention name(s): Abobotulinumtoxin A injection for bruxism
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Botulinum toxin injection for bruxism
Intervention MeSH terms: Botulinum Toxins; abobotulinumtoxinA; Botulinum Toxins, Type A
Intervention model: Single Group Assignment
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).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botulinum toxin; treatment; bruxism; myofascial pain syndrome