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

Primary Purpose

Malocclusion Class II

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser therapy
Sponsored by
mahmoud abdelhameed mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion Class II

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

laser group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2020
Last Updated
May 3, 2020
Sponsor
mahmoud abdelhameed mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT04376190
Brief Title
Effect of Low Level Laser Therapy on the Temporomandibular Joint During Treatment of Skeletal Class II Malocclusion
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
August 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
mahmoud abdelhameed mohamed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
laser group and control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
12 patients treated with twin block functional appliance without low-level laser application for 9 month
Arm Title
laser group
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
low level laser therapy
Other Intervention Name(s)
photobiomodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of condylar volume (mm3) and condylar head position before and after Twin-block therapy with and without LLLT:
Description
3D condylar volume measured using software and 2D condylar head position
Time Frame
after 9 mouth from starting treatment
Secondary Outcome Measure Information:
Title
Changes of cephalometric skeletal measurements before and after Twin-block therapy with and without LLLT
Description
measured ANB, SNA, SNB effective mandibular, ramus, and corpus lengths
Time Frame
after 9 mouth from starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud A Mohamed, MSc student
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dental Medicine (Boys), Al- Azhar University,
City
Cairo
State/Province
Cairo Nasr City
ZIP/Postal Code
11751
Country
Egypt

12. IPD Sharing Statement

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

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