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

Not Applicable

Completed

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

• Registration Number: NCT05194488
• Lead Sponsor: Nourhan M.Aly

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-03
• Study Start: 2022-01-10
• Study First Posted: 2022-01-18
• Primary Completion: 2022-05-20
• Study Completion: 2022-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anterior repositioning appliance	Anterior repositioning appliance	-
Low level laser therapy	Low level laser therapy	-
Botulinum toxin type A	Botulinum toxin type A	-

Primary Outcome Measures

Name	Time	Method
Pain level	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.
Temporomandibular joint dysfunction	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
Temporomandibular joint clinical evaluation	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt