Efficacy of Botulinum Toxin in Temporomandibular Disorders

Phase 2

Completed

• Conditions: Temporomandibular Joint Disorder Bilateral
• Interventions: Drug: Botulinum toxin type A injection

• Registration Number: NCT05651256
• Lead Sponsor: University of Salamanca

Brief 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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-03-30
• Study Completion: 2021-07-30
• Study First Submitted: 2022-11-15
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TREATMENT	Botulinum toxin type A injection	BEFORE TREATMENT/AFTER TREATMENT A 1 cc marked insulin syringe was used for intramuscular injection of the prepared solution, according to the locations and amounts proposed with a total dose of 100 U (Type A toxinum botulinum, Allergan) in each patient, distributed at the different injection sites: 40 U in the masseter muscle, (0.1 cc=10 U), 20 U in the area of greatest hypertrophy (anterior inferior masseter), 10 U in the direction of the mandibular inferior border and 10 U in the area of the posterior inferior masseter; 20 U in the lateral pterygoid muscle (10 U extraorally between the zygomatic arch and sigmoid notch and 10 U intraorally, behind the maxillary tuberosity); 20 U in the TMJ, 10mm anterior to the tragus and 2mm below the zygomatic arch and 20 U in the anterior part of the temporalis muscle.

Primary Outcome Measures

Name	Time	Method
Measurement of pain intensity in the masticatory musculature	6 weeks	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.
Complications in the administration of botulinum toxin	6 weeks	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.

Trial Locations

Locations (1)

Clinica Odontológica de la Universidad de Salamanca; 🇪🇸 Salamanca, Spain