Efficacy of Botulinum Toxin in Temporomandibular Disorders

Temporomandibular Joint Disorder Bilateral Clinical Trial

— TMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05651256
• Other study ID #: PI 2021 04 734
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: December 2022
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• The study included patients diagnosed with TMDs, according to the established diagnostic criteria, aged between 18 and 69 years (both included) and with unilateral painful symptomatology of more than three months' duration.

Exclusion Criteria:

• Patients previously treated with surgery/arthrocentesis of the TMJ; patients treated in the last six months with surgery in the cervicofacial region; patients who, at the time of inclusion in the study, were being treated in a "Pain Unit" and patients who had previously received treatment with BTX.

Related Conditions & MeSH terms

• Disease
• Joint Diseases
• Temporomandibular Joint Disorder Bilateral
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Clinica Odontológica de la Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of pain intensity in the masticatory musculature	Pain intensity was evaluated through the visual analogue scale (VAS). The patients determined the intensity of pain in the different locations of the craniofacial region (temporal muscle, masseter muscle, pterygoid muscle, and TMJ) in a range of 0 to 10, before and after the administration of botulinum toxin.; 0 was the absence of pain and 10 the intensity of maximum pain. The percentage of patients in whom the pain intensity of the masticatory muscles decreased after treatment with botox type A was analyzed.	6 weeks
Primary	Complications in the administration of botulinum toxin	Adverse side effects assessed included warmth, redness, and bruising at the injection site, swallowing disturbance, contracture or pain of the contralateral muscle, and abnormal jaw movements.; Therefore, the percentage of patients included in the study who presented complications after the injection of botulinum toxin according to the established parameters was analyzed.	6 weeks