NCT05651256

Efficacy of Botulinum Toxin in Temporomandibular Disorders

Preliminary Findings of the Efficacy of Botulinum Toxin in Temporomandibular Disorders: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

Temporomandibular disorders (TMDs) represent a multifactorial pathological group that gives rise to a varied and complex symptomatology that includes decreased jaw movement, muscle and joint pain, joint crepitation and limitation or functional deviation of the jaw opening. All this is sometimes accompanied by headache and other painful symptoms in the neck musculature, incapacitating for many patients and at considerable public health expense. Intramuscular and intra-articular injections of botulinum toxin are a simple treatment that has proven to be effective in the treatment of the painful symptoms of these disorders, being a therapeutic option in situations of failure of conventional treatments, without presenting adverse effects. Our study presents the preliminary results of twenty patients treated with this therapy

Detailed description

TMDs are a common pathology affecting up to 70% of the population, with a maximum incidence in young patients. We used a sample of twenty patients recruited in the Maxillofacial Surgery Service of the University Hospital of Salamanca (Spain), who met the inclusion criteria, with unilateral painful symptomatology of more than three months duration. All patients were randomly treated by intramuscular and intra-articular injections of BTX (100 U) in 8 predetermined points. Pain symptomatology was assessed at the different locations, together with joint symptomatology, at baseline and 6 weeks after treatment. Adverse effects were also evaluated. In 85% of the patients, pain on oral opening improved and 90% showed improvement of pain on mastication. A 75% of the patients reported improvement in joint clicking/noise. Headaches improved or disappeared in 70% of the patients treated. Despite the limitations of the study and the preliminary results, intramuscular and intra-articular infiltrations with BTX were effective in the treatment of symptoms associated with TMDs, with minimal adverse effects.

Conditions

• Temporomandibular Joint Disorder Bilateral

Interventions

Type	Name	Description
DRUG	Botulinum toxin type A injection	The solution for injection was prepared immediately before the intervention, by dissolving the vials of BTX, kept refrigerated at 5ºC, in 1 ml of sterile saline solution at room temperature. Eight injection sites were marked, three located in the masseter muscle, two in the lateral pterygoid muscle, one in the temporomandibular joint (TMJ) and two in the temporalis muscle. A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed by Kim et al. and Ho et al. with a total dose of 100 U in each patient.distributed at the different injection sites.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-03-30
• Completion: 2021-07-30
• First posted: 2022-12-14
• Last updated: 2022-12-14

Locations

1 site across 1 country: Spain