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Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05863286
Enrollment
28
Registered
2023-05-18
Start date
2022-12-30
Completion date
2024-03-31
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dislocation of Temporomandibular Joint TMJ, Subluxation of Temporomandibular Joint

Keywords

Botulinum Toxin, Tmj Subluxation

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

Interventions

DRUGBotulinum toxin type A

Botulinum toxin is produced by the gram-positive, anaerobic, spore-forming bacterium Clostridium botulinum, and is one of the most lethal biological toxins known to man. Botulinum toxin has seven antigenically different serotypes and exerts a paralytic action by rapidly and strongly binding to presynaptic cholinergic nerve terminals. It is then internalized and ultimately inhibits the exocytosis of acetylcholine by decreasing the frequency of acetylcholine release. Without its nerve supply, the muscle fiber will deteriorate; however, the muscle will regain its strength as the nerves regenerate.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of luxation6 monthsPostoperative frequency of luxation is measured by number of luxation per day in organized sheet
Maximum Mouth opening6 monthsPostoperative Maximum Mouth opening is measured by digital caliper in follow up intervals 1 week, 1 month, 3 month, 6 month

Secondary

MeasureTime frameDescription
Lateral mandibular movement6 monthsPostoperative lateral mandibular movement side to side movement is measured by digital caliper in follow up intervals 1 week, 1 month, 3 month, 6 month

Countries

Egypt

Contacts

Primary ContactAmr Ehab Shaaban, Bachelor of dental science
amr.ehab@dentistry.cu.edu.eg01111056697
Backup ContactAhmed Mohamed Yousef, Doctor of dental science
dr.ayousef@gmail.com01067941236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026