Efficacy of Botulinum Toxin in Temporomandibular Disorders

NCT05651256 | Completed Phase 2

• 1 other identifier: PI 2021 04 734
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Temporomandibular Joint Disorder Bilateral

Keywords

Botulinum toxin; Temporomandibular joint disorders; Masticatory disfunction syndrome; Randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

TREATMENT

EXPERIMENTAL

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.

Drug: Botulinum toxin type A injection

Interventions

Botulinum toxin type A injection DRUG

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.

Also known as: Botox® 100 U, Allergan Pharmaceuticals Westport, Ireland

TREATMENT

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

Location

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MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• JAVIER MONTERO, PROFESSOR

  Salamanca University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: clinical trial

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 14, 2022
• Study Start: March 1, 2021
• Primary Completion: March 30, 2021
• Study Completion: July 30, 2021
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)