Effect of Low Level Laser Therapy in Accelerating Tooth Movement For Dental Crowding Cases

Study Overview
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Brief Summary
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26 participants from the Orthodontic Department at University of Damascus Dental School will be randomly assigned into two groups. In the experimental group, a low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 j per each tooth. Control group will undergo typical orthodontic treatment with the laser device applied the same manner but without being turned on (to get the placebo effect for pain reduction effect). This procedure will be repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the end of the leveling and alignment stage.

Detailed Description
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The long time needed for orthodontic treatment is considered one of the biggest obstacles which make patients refuse to undergo treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. It also combined commonly with pain, which reducing patient acceptance and cooperation with treatment. Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of root resorption. A recent systematic review states that low level laser therapy has shown efficiency in accelerating orthodontic tooth movement, but there is a need for more studies to determine the best protocols regarding energy and frequency. A review of the literature shows that there is no randomized controlled trails evaluating its efficiency in accelerating orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of this study.

Official Title
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Evaluation of Low-Level Laser Therapy (LLLT) Effectiveness in Accelerating Orthodontic Tooth Movement For Dental Crowding Cases: A Randomized Controlled Clinial Trial

Conditions
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Maxillary Crowded Teeth

Intervention / Treatment
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* Radiation: low level laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged between (16 - 24) years. Moderate crowding (3 - 5) mm in the anterior region of the maxillary dental arch with an irregularity index of (7 mm or more) mm according to Little Index with an indication to extract upper two premolars. All upper teeth are existed (except for third molars). Patients have not undergone previous orthodontic treatment. Patients have not undergone any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …). Patient with good oral hygiene (Plaque Index less than 1). Exclusion Criteria: Any medical condition affecting orthodontic tooth movement. Bad oral hygiene (Plaque Index greater than 1). Any peri-apical lesions developed during treatment. Patient lack of commitment toward follow-up appointments.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 24 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Decrowding<br>Crowded upper incisors will be treated in the conventional manner with a fake irradiation without using low level laser therapy. | |
| Experimental: Low Level Laser Therapy<br>Each maxillary incisor will be subjected to low level laser therapy at specific times in order to accelerate tooth movement | Radiation: low level laser therapy<br>* low level laser therapy is intended to accelerate tooth movement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Leveling and Alignment Time (OLAT) | As mentioned above | This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment. | 
| Change in Leveling and Alignment Improvement Percentage (LAIP) | LAIP will be measured by dividing the amount of change in LII value at a specific time intervals (i.e. T3-T0, T2-T0, T1-T0; calculated by subtracting LII value at T1, T2 and T3 from LII value at (T0) by LII value at T0 (i.e. the beginning of treatment). | this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of levels of pain | Using a visual analog scale, each patient will indicate the severity of his/her perceived pain. | Using a visual analog scale (VAS), pain will be measured after 1, 6, 24, 48, 72 hours of applying the laser therapy and at 7 days of follow-up. |