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

Not Applicable

Completed

• Conditions: Malocclusion Class II
• Interventions: Radiation: low level laser therapy

• Registration Number: NCT04376190
• Lead Sponsor: mahmoud abdelhameed mohamed

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.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2019-07-15
• Study Completion: 2019-08-20
• Status Verified: 2020-05
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-03
• Last Update Submitted: 2020-05-03
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser group	low level laser therapy	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

Primary Outcome Measures

Name	Time	Method
Changes of condylar volume (mm3) and condylar head position before and after Twin-block therapy with and without LLLT:	after 9 mouth from starting treatment	3D condylar volume measured using software and 2D condylar head position

Secondary Outcome Measures

Name	Time	Method
Changes of cephalometric skeletal measurements before and after Twin-block therapy with and without LLLT	after 9 mouth from starting treatment	measured ANB, SNA, SNB effective mandibular, ramus, and corpus lengths

Trial Locations

Locations (1)

Faculty of Dental Medicine (Boys), Al- Azhar University,; 🇪🇬 Cairo, Cairo Nasr City, Egypt