Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction

Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)

Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disc Displacement, With Reduction
• Intervention / Treatment: Device: Low level laser therapy; Drug: Botulinum toxin type A; Device: Anterior repositioning appliance

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• TMJ with audible and palpable click.
• Patients with anterior disc displacement as detected by MRI.
• Presence of full or nearly full complement of natural teeth.

Exclusion Criteria:

• Patients who have radiographic evidence of degenerative conditions of TMJ.
• Patients who have anterior disc dislocation without reduction.
• Previous history of TMD treatment.
• History of recent trauma.
• The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
• Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
• Pregnant and lactating females.
• Patients with known allergy to botulinum toxin type A.
• Patients suffering from neurological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low level laser therapy	Device: Low level laser therapy; Patients will receive low-level laser therapy on the temporomandibular joint disc; Other Names: LLLT
Experimental: Botulinum toxin type A	Drug: Botulinum toxin type A; Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.; Other Names: Botox
Active Comparator: Anterior repositioning appliance	Device: Anterior repositioning appliance; Patients will receive hard maxillary anterior repositioning appliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporomandibular joint dysfunction	Using Helkimo Anamnestic Index that includes 5 items, each having 3 possible answers scored 0, 1 or 5. The 1st item assesses limitations in range of jaw movement & is divided to 4 sections: maximum mouth opening, protrusion & lateral shift. For mouth opening , value of >40mm scores 0, 30-39mm scores 1 & <30mm scores 5. Protrusion & lateral shifts score 0 if the measurement is ≥7mm, 1 if ranging between 4-6mm and 5 if it is <4mm. These sections are added together to get a total that scores 0 if the sum of the 4 sections is 0, 1 if the subtotal is between 1-4 & 5 if the subtotal is >4. The 2nd item evaluates joint alterations that produce deviations, sounds and joint locks. The 3rd item evaluates pain when performing movements. The 4th item evaluates masticatory muscles pain. The 5th item evaluates pain on palpation in the prearticular area of TMJ. The 5 items are added and scored; 0: no TMJ involvement, 1-9: mild involvement, 10-19: moderate involvement & 20-25: severe involvement	3 months
Pain level	This will be assessed using the visual analogue scale (VAS) with score ranges from 0 (lowest) to 10 (highest). Higher scores indicate greater pain levels.	3 months
Temporomandibular joint clinical evaluation	Magnetic Resonance Imaging (MRI) will be performed for all patients using a 3 Tesla MRI scanner with a head coil. Gradient T2 (T2*) and proton-density (PD) weighted spin echo (SE) sequences will be carried out in closed and open mouth positions in the oblique sagittal plane. MRI is considered the gold standard (objective) in imaging the soft tissue components of the TMJ.	3 months

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Principal Investigator: Mariam M Bahgat, M.Sc, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Nermeen A Rady, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Ahmed M Abdelhamid, PhD, Faculty of Dentistry, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 3, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: IRB 00010556 (ethical approval number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No