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

NCT05194488 | Completed

• 1 other identifier: IRB 00010556
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Disc Displacement, With Reduction

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Low level laser therapy

EXPERIMENTAL

Device: Low level laser therapy

Botulinum toxin type A

EXPERIMENTAL

Drug: Botulinum toxin type A

Anterior repositioning appliance

ACTIVE COMPARATOR

Device: Anterior repositioning appliance

Interventions

Low level laser therapy DEVICE

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

Also known as: LLLT

Low level laser therapy

Botulinum toxin type A DRUG

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

Also known as: Botox

Botulinum toxin type A

Anterior repositioning appliance DEVICE

Patients will receive hard maxillary anterior repositioning appliance.

Anterior repositioning appliance

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (1)

• Rady NA, Bahgat MM, Abdel-Hamid AM. Promising minimally invasive treatment modalities for symptomatic temporomandibular joint disc displacement with reduction: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 1;22(1):547. doi: 10.1186/s12903-022-02579-3.

  PMID: 36456937 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Botulinum Toxins; 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

• Mariam M Bahgat, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Nermeen A Rady, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

• Ahmed M Abdelhamid, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 18, 2022
• Study Start: January 10, 2022
• Primary Completion: May 20, 2022
• Study Completion: June 1, 2022
• Last Updated: December 4, 2023

Record last verified: 2023-12

Locations

EG (1)