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

NCT ID: NCT04376190

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-08-20

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.

Detailed Description

to evaluate the 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

laser group

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

Group Type: EXPERIMENTAL

low level laser therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention Names

photobiomodulation

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

mahmoud abdelhameed mohamed

OTHER

Sponsor Role: lead

Responsible Party

mahmoud abdelhameed mohamed

Dentist, Ministry of Health, Egypt, MSc studentDepartment of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mahmoud A Mohamed, MSc student

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

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

Cairo, Cairo Nasr City, Egypt

Countries

Egypt

Other Identifiers

AlAzharU 7712

Identifier Type: -

Identifier Source: org_study_id