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

NCT04376190 | Completed

• 1 other identifier: AlAzharU 7712
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes of condylar volume (mm3) and condylar head position before and after Twin-block therapy with and without LLLT:

  3D condylar volume measured using software and 2D condylar head position

  after 9 mouth from starting treatment

Secondary Outcomes (1)

• Changes of cephalometric skeletal measurements before and after Twin-block therapy with and without LLLT

  after 9 mouth from starting treatment

Study Arms (2)

control group

NO INTERVENTION

12 patients treated with twin block functional appliance without low-level laser application for 9 month

laser group

EXPERIMENTAL

12 patients treated with twin block functional appliance with low-level laser application 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. The laser was applied 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. Laser application was repeated weekly for three months according to a standard protocol

Radiation: low level laser therapy

Interventions

low level laser therapy RADIATION

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.

Also known as: photobiomodulation

laser group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal Class II (ANB°\> 5°) with the normal maxilla (SNA°=82°±4°) and retrognathic mandible (SNB°\< 78°).
• Overjet greater than 5 mm.
• Minimal crowding in dental arches (≤ 3 mm).
• The lower incisors should be on average inclination or slightly retroclined.
• All the patients were in stages II and III based on the modified cervical vertebral maturation stages(CVMS) according to Bacetti et al.

You may not qualify if:

• Previous history of orthodontic treatment.
• Congenitally missing or extracted permanent tooth (except third molars).
• Posterior crossbites or severe maxillary transverse deficiency.
• Severe facial asymmetry determined by clinical or radiographic examination.
• Poor oral hygiene.
• Systemic diseases that may affect orthodontic treatment results.

Sponsors & Collaborators

• mahmoud abdelhameed mohamed: lead

Study Sites (1)

Faculty of Dental Medicine (Boys), Al- Azhar University,

Cairo, Cairo Nasr City, 11751, Egypt

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Mahmoud A Mohamed, MSc student

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist, Ministry of Health, Egypt, MSc studentDepartment of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.

Model Details: laser group and control group

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 6, 2020
• Study Start: December 1, 2017
• Primary Completion: July 15, 2019
• Study Completion: August 20, 2019
• Last Updated: May 6, 2020

Record last verified: 2020-05

Locations

EG (1)