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

Sponsor
Nourhan M.Aly (Other)
Overall Status
Recruiting
CT.gov ID
NCT05194488
Collaborator
(none)
27
Enrollment
1
Location
3
Arms
4.7
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Low level laser therapy
  • Drug: Botulinum toxin type A
  • Device: Anterior repositioning appliance
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction (A Randomized Clinical Trial)
Actual Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
May 20, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Alexandria University Alexandria Egypt 21512

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nourhan M.Aly, Assistant Lecturer of Dental Public Health, University of Alexandria
    ClinicalTrials.gov Identifier:
    NCT05194488
    Other Study ID Numbers:
    • IRB 00010556
    First Posted:
    Jan 18, 2022
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Feb 18, 2022