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Completed

NCT Number: NCT05194488

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

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.

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Key information

Conditions

Temporomandibular Joint Disc Displacement, With Reduction

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Level Laser Therapy

Device

Patients will receive low-level laser therapy on the temporomandibular joint disc

Other names: LLLT

Botulinum Toxin Type A

Drug

Patients will receive Botulinum toxin type A injection into the lateral pterygoid muscle under Electromyography (EMG) guidance.

Other names: Botox

Anterior repositioning appliance

Device

Patients will receive hard maxillary anterior repositioning appliance.

Primary outcomes

  1. Temporomandibular joint dysfunction

    Time frame: 3 months

    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

  2. Pain level

    Time frame: 3 months

    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. Temporomandibular joint clinical evaluation

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2022
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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