Assessment of Botulinum Toxin Injection for Treatment of Temporomandibular Joint Dislocation

NCT05863286 | Unknown

• 1 other identifier: 11 12 22
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Dislocation of Temporomandibular Joint TMJ; Subluxation of Temporomandibular Joint

Keywords

Botulinum Toxin; Tmj Subluxation

Outcome Measures

Primary Outcomes (2)

• Frequency of luxation

  Postoperative frequency of luxation is measured by number of luxation per day in organized sheet

  6 months

• Maximum Mouth opening

  Postoperative Maximum Mouth opening is measured by digital caliper in follow up intervals" 1 week, 1 month, 3 month, 6 month"

  6 months

Secondary Outcomes (1)

• Lateral mandibular movement

  6 months

Study Arms (2)

botulinum toxin type A injection in lateral pterygoid muscle

EXPERIMENTAL

Botulinum toxin type 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. The Lateral pterygoid 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

Drug: Botulinum toxin type A

Placebo "Saline 0.9%" injection in lateral pterygoid muscle

PLACEBO COMPARATOR

0.25 ml of normal saline will be loaded in a 1-ml insulin syringe attached to a needle with 27 Gauge and 31 mm length. The Lateral pterygoid 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 normal saline

Drug: Botulinum toxin type A

Interventions

Botulinum toxin type A DRUG

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.

Also known as: Botulinum Toxin

Placebo "Saline 0.9%" injection in lateral pterygoid muscle; botulinum toxin type A injection in lateral pterygoid muscle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with neurogenic cause of TMJ Hypermobility.
• Drug-induced TMJ Hypermobility

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, Elmanial, Cairo, 12613, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 21757278 RESULT

MeSH Terms

Interventions

Botulinum Toxins, Type A; Botulinum Toxins

Intervention Hierarchy (Ancestors)

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

• Hamida Refai, Doctor of dental science

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Amr Ehab Shaaban, Bachelor of dental science

CONTACT

01111056697; amr.ehab@dentistry.cu.edu.eg

Ahmed Mohamed Yousef, Doctor of dental science

CONTACT

01067941236; dr.ayousef@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Amr Shaaban, BDS "Prinicipal Investigator"

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 18, 2023
• Study Start: December 30, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)