Effect Of Low Level Laser Therapy on the Rate of En- Masse Retraction: RCT

Study Overview
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Brief Summary
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There is scarcity in the literature regrading the effect of Low Level Laser Therapy (LLLT) on the rate of en-masse retraction. This study aims to investigate whether LLLT would affect the rate of en-masse retraction in females having bimaxillary dento-alveolar protrusion.

Detailed Description
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Individuals having bimaxillary dentoalveolar protrusion are characterized by proclined upper and lower incisors and increased procumbency of the lips thus suffering from poor facial esthetics. The conventional management of these patients is the extraction of the first premolars and retraction of the anterior teeth. One of the treatment techniques is in the form of canine retraction followed by four incisors retraction. This conventional method takes tedious work and tremendous time, thus affecting the patients' satisfaction adversely. The other technique is retraction of the whole set of anterior teeth as one unit (Canine and incisors), which is referred to as En-Masse retraction. Enhancing the rate of orthodontic tooth movement has always been a supreme goal of orthodontic research hoping to raise the level of care delivered to patients, hence, increase patients' satisfaction. One of the proposed modalities of increasing the rate of tooth movement is Low Level Laser Therapy (LLLT). Thus, the aim of the current consideration was to evaluate the impact of LLLT on the rate of en-masse retraction in adult females having bimaxillary dentoalveolar protrusion.

Official Title
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Effect of Low-level Laser Therapy on the Rate of En-masse Retraction in Adult Females With Bimaxillary Dentoalveolar Protrusion: a Single-center Randomized Clinical Trial

Conditions
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Bimaxillary Protrusion

Intervention / Treatment
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* Procedure: En- masse retraction and LLLT
* Procedure: En- masse retraction without LLLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult females Patients having bimaxillary dento- alveolar protrusion and Class I Molar relation Cases requiring maximum anchorage during retraction. Good general and oral health Exclusion Criteria: Patients suffering from any systemic diseases interfering with tooth movement. Patients with extracted or missing permanent teeth. (except for third molars). Patients with badly decayed teeth (Other than 1st premolars). Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc…). Patients with previous orthodontic treatment Pregnant females

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: LG (Group A)<br>En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. Retraction was done along with the application of LLLT till the end of retraction. | Procedure: En- masse retraction and LLLT<br>* Retraction will start on a 0.019x0.025 Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs. LLLT will be applied on days 0,3,7,14 from extraction then repeated biweekly till the end of retraction.<br>* Other names: Group A;|
| Active Comparator: NLG (Group B)<br>En- masse retraction using NiTi closed coil springs rendering 200 g/side were employed following first premolars extraction and insertion of buccal TADs to provide maximum anchorage. No LLLT was applied to this group | Procedure: En- masse retraction without LLLT<br>* Retraction will start on a 0.019x0.025 Stainless steel wire using NiTi closed coils (force applied will be 200 g per side) extending between the crimpable hooks and the TADs.<br>* Other names: Group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of en-masse retraction | The antero-posterior movement of anterior teeth will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm) | From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior teeth's root resorption | Assessed via comparing the pre & post- retraction CBCTs using Lavender & Malmgren Grading system | From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year | 
| Anterior teeth Tip and Torque | By comparing angular changes in the teeth's tip and torque in relation to reference planes | From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year | 
| Anchorage (Loss/ Gain) | By comparing linear and angular changes in the first molars in relation to reference planes | From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year | 
| First molars' rotation | Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line | From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year | 
| Pain Associated | Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 0-10 | From date of first premolars' extraction until the date of anterior teeth retraction, assessed up to an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D, En-masse retraction, Rate of tooth movement, Low Level Laser Therapy (LLLT)