Treatment of Class II Malocclusion Combined With Low-level Laser

Study Overview
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Brief Summary
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This experimental study will evaluate the effect of combined treatment with low-level laser and functional appliances (twin-block) on the correction of Class II malocclusion, compared with the control group treated with functional appliances (twin-block) only. The study sample will consist of 40 patients with Class II malocclusion. The sample will be allocated randomly into two groups: a control group and an experimental group. Functional appliance (twin-block) will be applied for all patients. Low-level laser will be applied for the experimental group only. The skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated individually.

Detailed Description
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Class II malocclusion is considered as the most common malocclusion between patients. Recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth. This study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment. Twin-block will be applied in two groups: The control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the TMG region. Cephalometric radiographs will be gotten before and after functional treatment to evaluate the dento-skeletal changes.

Official Title
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The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial

Conditions
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Malocclusion, Angle Class II

Intervention / Treatment
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* Device: Twin-block appliance
* Other: Low level laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletal Class II malocclusion because of mandibular retrognathia ANB > 4 Overjet > 5 SNB < 78 Exclusion Criteria: Poor oral hygiene Previous orthodontic treatment. Patients with syndromes, clefts, or craniofacial abnormalities. Reason of contraindication of functional treatment

Ages Eligible for Study
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Minimum Age: 11 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 group<br>Functional treatment will be applied using the Twin-block appliance. | Device: Twin-block appliance<br>* Functional treatment will be achieved using the Twin-block appliance<br>|
| Experimental: Twin-block combined with low level laser<br>Functional treatment will be applied using the Twin-block appliance combined with low level laser. | Device: Twin-block appliance<br>* Functional treatment will be achieved using the Twin-block appliance<br>Other: Low level laser<br>* Functional treatment will be combined with low-level laser therapy on the TMG region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of functional treatment | The duration of the functional treatment will be measured and compared between groups. | After functional treatment which will take approximately 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentoskeletal effects of the functional treatment | Dentoskeletal changes before and after functional treatment combined with Low-level Laser compared with those of the control group (SNA, SNB, ANB, Overjet ,…etc) using lateral cephalometric radiographs. | Changes will be evaluated before and after functional treatment which will take approximately 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Low-level laser, functional treatment, twin-block