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CompletedNCT06103110Updated Oct 26, 2023

Effect of Order and Conjugation of Different Photobiomodulation Therapies and Anterior Repositioning Appliance in Management of TMD Cases

An interventional study of Photobiomodulation in TMJ Disorder, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Oct 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

This study aimed to evaluate the effect of using Low level laser therapy / Infrared led therapy with anterior repositioning appliance in anterior dislocation patients with reduction (ADDwR) concerning:

  1. Range of mandibular motion
  2. Helkimo questioner to evaluate :

A -TMJ function B -Muscle pain C -TMJ pain D - Pain on movement of the mandible

Four groups created randomly each 10 patients as following:-

Group 1: anterior repositioning appliance followed by Infra-red LED therapy Group 2: Infra-red LED therapy followed by anterior repositioning appliance Group 3: anterior repositioning appliance followed by Low level Laser therapy Group4: Low level Laser therapy followed by anterior repositioning appliance

Evaluation was done through the following methods

Clinical examination:

  1. A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
  2. Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction confirmed by MRI.
  3. Maximum inter-incisal opening (MIO):was measured by Vernier caliper in millimetres (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors.
  4. Range of lateral mandibular excursions was also measured using Vernier caliper in millimetres as the horizontal distance extending from maxillary midline to mandibular midline. This was measured by asking the patient to move the mandible to one side then to the other side to the maximum extent.
  5. Helkimos clinical dysfunction scale.
Read the detailed description

This study included forty patients suffering from TMJ internal derangement with reduction. They were all selected from the outpatient clinic of the Prosthodontics Department, Faculty of Dentistry, Mansoura University. All the included patients showed persistent restriction of mouth opening as well as TMJ pain and clicking. Patients suffering from inflammatory or connective tissue diseases, neurologic disorders, history of bony or ibrous adhesion, gross mechanical restrictions and condylar fractures, previous TMJ surgery, TMJ ankylosis, or acute infection were all excluded. Moreover, muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks were also excluded in this study.

Clinical examination:

  1. A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
  2. Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction was confirmed by MRI.
  3. Maximum inter-incisal opening (MIO):was measured by Vernier caliper in millimetres (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors.
  4. Range of lateral mandibular excursions was also measured using Vernier caliper in millimetres as the horizontal distance extending from maxillary midline to mandibular midline. This was measured by asking the patient to move the mandible to one side then to the other side to the maximum extent.
  5. Helkimos clinical dysfunction scale.

Four groups created randomly each 10 patients as following:-

Group 1: anterior repositioning appliance followed by Infra-red LED therapy Group 2: Infra-red LED therapy followed by anterior repositioning appliance Group 3: anterior repositioning appliance followed by Low level Laser therapy Group4: Low level Laser therapy followed by anterior repositioning appliance

Anterior Repositioning Appliance

This appliance, is to alter the maxillomandibular relationship so that a more anterior position assumed by the mandible. Acrylic guiding ramp added to the anterior third of the maxillary appliance that direct the mandible into a more forward position, upon closing. This type of appliance designed to be used in treating patients with anterior disk displacement with reduction. It was supposed that by altering the mandibular position in this manner, the anteriorly displaced disks could return back to its normal position (recaptured).

LOW LEVEL LASER APPLICATION The LLLT were applied bilaterally to the face, five points were irradiated: three points around the TMJ, one point on the temporalis and one on the masseter. The treatment was performed twice a week for three consecutive weeks

INFRA RED LED APPLICATION The LED therapies were applied bilaterally to the face for 60 s/point. Five points were irradiated: three points around the TMJ, one point on the temporalis and one on the masseter. Eight sessions of the phototherapy were performed, twice a week for 4 weeks

Follow up:

Patients were re-examined for maximum openening ,lateral movement and Helkimos scale after 6 months.

02

Conditions studied

  • TMJ Disorder
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 40 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • suffering from TMJ internal derangement with reduction.
  • All the included patients show persistent restriction of mouth opening as well as TMJ pain and clicking.

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from inflammatory or connective tissue diseases,
  • neurologic disorders
  • history of bony or fibrous adhesion
  • gross mechanical restrictions and condylar fractures
  • previous TMJ surgery
  • TMJ ankylosis
  • acute infection
  • muscle relaxants, non-steroidal anti-inflammatory drugs within 48 h preoperatively, corticosteroid injection at treatment site within one month or systemic use of corticosteroids within 2 weeks
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    anterior repositioning appliance followed by Infra-red LED therapy

    anterior repositioning appliance followed by Infra-red LED therapy

    Device: Photobiomodulation

  • Experimental
    Infra-red LED therapy followed by anterior repositioning appliance

    Infra-red LED therapy followed by anterior repositioning appliance

    Device: Photobiomodulation

  • Experimental
    anterior repositioning appliance followed by Low level Laser therapy

    anterior repositioning appliance followed by Low level Laser therapy

    Device: Photobiomodulation

  • Experimental
    Low level Laser therapy followed by anterior repositioning appliance

    Low level Laser therapy followed by anterior repositioning appliance

    Device: Photobiomodulation

Interventions

  • DevicePhotobiomodulation

    Laser therapy using low level laser

06

What researchers measure

Primary outcomes

  1. Range of motion

    Maximum opening, lateral movement and protrusion

    Time frame: Before treatment (T0) , After 6 months (T6)

07

Study locations

1 site
  • Mansoura University, Faculty of dentistry
    Mansoura, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06103110
Lead sponsor
Mansoura University
Responsible party
Mohamed shady (Assistant Professor, Mansoura University) — Principal investigator
First posted
Oct 26, 2023
Start date
Oct 20, 2022
Primary completion
Jun 24, 2023
Completion
Aug 3, 2023
Last update
Oct 26, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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