NCT06103110

Brief 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. 1.Range of mandibular motion
  2. 2.Helkimo questioner to evaluate :
  3. 3.A detailed questionnaire by the examiner was recorded for each patient including: personal data, chief complaint, medical as well as past dental histories
  4. 4.Magnetic resonance imaging (MRI) for each patient, the clinical diagnosis of disc displacement with reduction confirmed by MRI.
  5. 5.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.
  6. 6.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.
  7. 7.Helkimos clinical dysfunction scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 22, 2023

Last Update Submit

October 22, 2023

Conditions

TMJ Disorder

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    Maximum opening, lateral movement and protrusion

    Before treatment (T0) , After 6 months (T6)

Study Arms (4)

anterior repositioning appliance followed by Infra-red LED therapy

EXPERIMENTAL

anterior repositioning appliance followed by Infra-red LED therapy

Device: Photobiomodulation

Infra-red LED therapy followed by anterior repositioning appliance

EXPERIMENTAL

Infra-red LED therapy followed by anterior repositioning appliance

Device: Photobiomodulation

anterior repositioning appliance followed by Low level Laser therapy

EXPERIMENTAL

anterior repositioning appliance followed by Low level Laser therapy

Device: Photobiomodulation

Low level Laser therapy followed by anterior repositioning appliance

EXPERIMENTAL

Low level Laser therapy followed by anterior repositioning appliance

Device: Photobiomodulation

Interventions

PhotobiomodulationDEVICE

Laser therapy using low level laser

Infra-red LED therapy followed by anterior repositioning applianceLow level Laser therapy followed by anterior repositioning applianceanterior repositioning appliance followed by Infra-red LED therapyanterior repositioning appliance followed by Low level Laser therapy

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 22, 2023

First Posted

October 26, 2023

Study Start

October 20, 2022

Primary Completion

June 24, 2023

Study Completion

August 3, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)