The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients

Study Overview
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Brief Summary
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this is a controlled clinical trial with 2 groups of patients of class II skeletal discrepancy due to mandibular retrusion one group is treated with twin block functional appliance and the other with twin block combined with low level laser therapy ,the study aims to detect the effect of low level laser on the skeletal outcomes , dentoalveolar outcomes, rate of correction and pain during treatment

Official Title
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The Effect of Low-level Laser Therapy on Functional Treatment of Skeletal Class II Patients

Conditions
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Class II Malocclusion

Intervention / Treatment
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* Other: twin block
* Other: twin block combined with low level laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age (early permanent dentition) Cervical maturation stage CS 3-4 Skeletal class II due to mandibular retrusion. Overjet more than 4mm. Exclusion Criteria: Cleft lip or palate. Systemic diseases. Previous orthodontic treatment or abnormal habits. Congenital craniofacial deformity. poor oral hygiene

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 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 |
| --- | --- |
| Experimental: twin block<br>group treated with twin block only | Other: twin block<br>* 2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy<br>|
| Experimental: twin block combined with low level laser<br>group treated with twin block combined with low level laser therapy | Other: twin block combined with low level laser<br>* 2 parallel groups one is treated with twin block and the other is treated with twin block combined with low level laser therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment time | comparison of treatment between the 2 different groups | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cephalometric measurements | digital tracing of pre and post treatment cephalograms of both groups and comparison of linear and angular measurements | 8 months | 
| study cast analysis | cast analysis of both groups measuring arch perimeter , intercanine wisth and intermolar width | 8 months | 
| the short form McGill pain questionnaire | comparison of questionnaire results between the 2 groups | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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twin block , functional appliance , low level laser , photobiomodulation