Clinical trial NCT05863286: Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
Official title: Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation: Double-blind, Randomized, Placebo Controlled Trail Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dislocation of Temporomandibular Joint TMJ
Subluxation of Temporomandibular Joint
Keywords: Botulinum Toxin
Tmj Subluxation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of the effect of Botulinum toxin injection on the frequency of luxation and TMJ Pain in patients with TMJ dislocation either chronic recurrent dislocation or subluxation

Detailed description: Diagnostic procedure:

1. Patient questionnaire: a questionnaire will be recorded by the examiner including the Chief complaint, Personal data, and Medical history.
2. Consent: Informed consent will be obtained from patients to participate in the study.
3. Clinical examination: TMJ examination with specific emphasis on the TMJ regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (Inspection and palpation).

   o operative procedures:

   • The surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion

   A-Botulinum Toxin Type A injection:

   BTX-A vial will be reconstituted with normal saline to obtain a 10 U/0.1 ml solution, 0.25 ml of this solution containing 25 U BTX-A will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length.

   B-The placebo comparator Injection:

   Patients in the placebo arm will receive equivalent volumes of placebo solution (Normal Saline).

   • Procedure

   - With the patient sitting in an upright position on the dental chair, the lateral ptreygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. The needle will be advanced perpendicular to the skin with the mouth closed. The muscle is approximately 3 to 4 cm deep. Aspiration will be carried out to avoid unintentional intravascular injection.

   According to the assigned group, the inferior head of Lateral pterygoid muscle will be injected with BTX-A or normal saline

   - The patient will be instructed to remain in an upright position for 6 h (to reduce diffusion into pharyngeal muscles which may cause dysphagia and nasal regurgitation).

   - Patients will be recalled weekly during the first month, then monthly after 3 months
   * Post-operative care:

   Paracetamol 1000 mg will be prescribed as needed Any excessive mouth opening should be avoided Soft diets are advised in the first 48 hours after injection

Eligibility criteria: Inclusion Criteria:

1. patients with TMJ habitual or recurrent dislocation
2. Age ≥ 18 years
3. The willingness of the patient to receive relative painful injections and to follow instructions

Exclusion Criteria:

1. Patients with neurogenic cause of TMJ Hypermobility.
2. Drug-induced TMJ Hypermobility

Primary outcomes:
measure: Frequency of luxation
timeFrame: 6 months
measure: Maximum Mouth opening
timeFrame: 6 months
Secondary outcomes:
measure: Lateral mandibular movement
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo university
state: Elmanial, Cairo
Study officials:
affiliation: Cairo University
name: Hamida Refai, Doctor of dental science
role: STUDY_DIRECTOR
References:
citation: Refai H, Altahhan O, Elsharkawy R. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial. J Oral Maxillofac Surg. 2011 Dec;69(12):2962-70. doi: 10.1016/j.joms.2011.02.128. Epub 2011 Jul 16.