The Role of Low Level Laser Therapy in Acceleration of Teeth Alignment in Lingual Orthodontic Patients

Study Overview
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Brief Summary
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We will treat patients with class I malocclusion who have moderate crowding (4-6 mm) according to Little's irregularity index and asses the efficacy of low level laser therapy in accelerating orthodontic tooth movement . There is two groups : treated with Low level laser therapy (LLLT) treated traditionally without any irradiation Patients will be randomly allocated in any group and all data will be collected through photographs when leveling and alignment completed. Also pain levels will be assessed using numeric rating scale to compare between the two groups and if laser really can relief pain or not .

Detailed Description
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The time of orthodontic treatment is considered to be one of the most concerns for patients. The study will investigate the effect of low level laser therapy on the speed of orthodontic tooth movement during the correction of moderately crowded anterior upper teeth using lingual orthodontic appliance. The study will be accomplished with two arms, the first is LLLT arm and the other is the control arm without any active intervention. 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. Within the limits of our knowledge, this is the first study in the world that will study acceleration of orthodontic tooth movement with lingual orthodontic .

Official Title
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Evaluation of Low-Level-LASER Therapy (LLLT) Effect on Accelerating Orthodontic Tooth Movement For Crowded Upper Incisors Leveling and Alignment in Lingual Orthodontic Patients: A Randomized Clinical Controlled Trial

Conditions
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Malocclusion, Angle Class I, Crowding

Intervention / Treatment
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* Radiation: low level laser therapy
* Device: Lingual Orthodontics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I malocclusion with mild to moderate crowding Old between 17-27 years Good oral hygiene Patients should be fit and well 4-6 mm crowding in upper incisors according to Little's index Enough clinical crowns length Exclusion Criteria: Patients who had an old orthodontic treatment People who have any drug or disease affect orthodontic movement Any contraindication for orthodontic treatment

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 27 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lingual orthodontics<br>Patients will be treated with lingual braces without being irradiation with low level laser therapy. Treatment will go forward in the normal manner. Archwires will be changed in the traditional way. | Radiation: low level laser therapy<br>* low level laser therapy will be used in order to induce tooth movement. 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 Joules/each tooth.<br>* Other names: soft tissue laser;Device: Lingual Orthodontics<br>* Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.<br>|
| Experimental: Low level laser therapy<br>Patients will be subjected to low level laser therapy during their orthodontic treatment using lingual braces. | Radiation: low level laser therapy<br>* low level laser therapy will be used in order to induce tooth movement. 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 Joules/each tooth.<br>* Other names: soft tissue laser;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of tooth alignment | Days required to complete tooth alignment will be counted. | When the treatment is completed (i.e. tooth alignment is achieved) and this is expected to take 100 days on average | 
| Change in Tooth Alignment at one month | Little's Index of Irregularity will be measured at 30 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment. | T1: one day before the beginning of treatment; T2: at 30 days after the onset of treatment. | 
| Change in Tooth Alignment at two months | Little's Index of Irregularity will be measured at 60 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment. | T1: one day before the beginning of treatment; T2: at 60 days after the onset of treatment. | 
| Change in Tooth Alignment at the end of Alignment Stage | Little's Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment. This index is measured on intraoral photographs of patients' teeth. The value obtained will be compared to the value obtained at the beginning of treatment. | T1: one day before the beginning of treatment; T2: when alignment of teeth is complete and this is expected to occur within 90 - 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the levels of pain and discomfort | Assessment will be performed using questionnaires via numeric rating scales (NRS) These levels will be assessed during the first stage of leveling and alignment. | T1: 10 minutes following the insertion of the first wire in the beginning of treatment; T2: at 24 hours post-commencement; T3: at 48 hours; T4: at 72 hours following the placement of primary archwire | 
| Change in Patients' Acceptance | Assessment will be performed using a standardized questionnaire | (1) one day following the beginning of the treatment, (2) after one week of the beginning of treatment, (3) after 4 weeks, (5) at the end the alignment stage which is expected to occur within 3 to 4 months |