Skip to content

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05194488
Enrollment
27
Registered
2022-01-18
Start date
2022-01-10
Completion date
2022-06-01
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disc Displacement, With Reduction

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.

Interventions

DEVICELow level laser therapy

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

DRUGBotulinum toxin type A

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

DEVICEAnterior repositioning appliance

Patients will receive hard maxillary anterior repositioning appliance.

Sponsors

Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Temporomandibular joint dysfunction3 monthsUsing 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
Pain level3 monthsThis 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 clinical evaluation3 monthsMagnetic 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026