Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement

Study Overview
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Brief Summary
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Aim of the present study is to evaluate the effect of low-level laser therapy on bone quality and quantity with orthodontic tooth movement.

Official Title
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Three-dimensional Assessment of the Bone Changes Accompanying Laser-assisted Orthodontic Tooth Movement: a Randomized Controlled Clinical Trial

Conditions
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Low Level Laser Therapy, Canine Retraction, Orthodontic Tooth Movement

Intervention / Treatment
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* Radiation: Low level laser therapy
* Other: without beam emission


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Malocclusion that requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site, such as Class I bimaxillary protrusion, and Class II division 1 cases. Normal shape and structure of the maxillary canines, with no history of root canal treatment Exclusion Criteria: Patients who underwent previous orthodontic treatment. Patients currently receiving drug therapy, e.g. hormonal therapy and corticosteroids, as well as patients with chronic diseases. Pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The study is a randomized controlled clinical trial, involving the split-mouth design, with one side of the maxillary arch serving as the control group, and the other side serving as the experimental group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low level laser therapy<br> | Radiation: Low level laser therapy<br>* The low-level laser applied will be a Diode laser* emitting infrared radiation at a wavelength of 980 nm, in a continuous mode. On the experimental side, subjects will receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, till the termination of the study period (3 months).<br>|
| Placebo Comparator: Control<br> | Other: without beam emission<br>* The laser tip will be held passively on the control side without beam emission, providing a placebo effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of alveolar bone density | Bone density will be measured from cone beam computed tomography (CBCT) scans at 2 different locations on each side of the upper arch; between the canine and lateral incisor, and between the canine and second premolar. Bone density will be measured using Hounsfield Units (HU). | 3 months | 
| Measurement of alveolar bone microstructure | From the CBCT scans, the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be examined. Bone microstructures will be measured and calculated with a dedicated software. | 3 months | 
| Measurement of buccal bone thickness | buccal bone thickness will be measured from the CBCT scans. Three points will be measured from the buccal bone to the root, at the coronal, mid-root, and apical level | 3 months | 
| Measurement of alveolar bone volume | From CBCT scans, bone volume in areas of the maxillary alveolar process between the canine and lateral incisor, and between the canine and second premolar will be measured | 3 months | 
| Measurement of bone Microstructure | Using the collected CBCT scans, the region of interest will be selected within the maxillary alveolar process, and fractal dimension analysis will be performed using a special software. | 3 months |