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

Malocclusion Class II Clinical Trial

Official title:

Three-dimensional Judgment of Mandibular Condylar Volume and Position Subsequent to Twin-block Functional Therapy of Skeletal Class II Malocclusion Accompanied With Low-level Laser Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376190
• Other study ID #: AlAzharU 7712
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 20, 2019

Study information

• Verified date: May 2020
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 20, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion Class II
• Malocclusion, Angle Class II

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dental Medicine (Boys), Al- Azhar University,	Cairo	Cairo Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
mahmoud abdelhameed mohamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes of cephalometric skeletal measurements before and after Twin-block therapy with and without LLLT	measured ANB, SNA, SNB effective mandibular, ramus, and corpus lengths	after 9 mouth from starting treatment