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Effect of Low Level Laser Therapy on the Temporomandibular Joint During Treatment of Skeletal Class II Malocclusion

NCT04376190 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-05-06

No results posted yet for this study

Summary

to evaluate effect of low-level laser therapy (LLLT) on mandibular condylar volume and position after treatment of Class II malocclusion with Twin Block (TB) functional therapy via cone beam computed tomography (CBCT).

Materials and methods: Twenty eight growing patients, 14 boys and 14 girls ranged in age 9-12 years, were randomly divided into control group (mean initial age 10.64±1.36 years) and laser group (mean initial age 10.55 1.45 years). All patients treated with TB appliance where Gallium aluminum arsenide diode laser applied in one group weekly around TMJ region for 12 sessions in three months with set parameters: continuous 635 nm, 50 mW, 4.5J/cm2, 45 seconds/ point, total dose per side 11.25J. CBCT were obtained before and immediately after TB therapy, in addition to routine orthodontic records. Changes in TMJ and skeletal variables were analyzed and compared within and between both groups.

Conditions

  • Malocclusion Class II

Interventions

RADIATION

low level laser therapy

In the laser group, patients received LLLT from a semiconductor Gallium Aluminum Arsenide diode laser (SMARTMPRO, LASOTRONIX, Poland) with the following set parameters; 635 nm wavelength in continuous-wave mode, 50 mw power output, 4.5 J/cm2 energy density, 11.25 J total dose per side, 45 seconds/ point, and 8 mm fiber optic tip diameter. Laser was applied (Fig.2) at five points located within TMJ region on both right and left sides in contact with skin as follows: lateral, superior, anterior, posterior, and posterior- inferior points.

Sponsors & Collaborators

  • mahmoud abdelhameed mohamed

    lead OTHER

Principal Investigators

  • Mahmoud A Mohamed, MSc student · Al-Azhar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-07-15
Completion
2019-08-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376190 on ClinicalTrials.gov