Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion

Study Overview
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Brief Summary
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This experimental study will evaluate the effect of combined treatment with low-intensity pulsed ultrasound (LIPUS) 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: control group and experimental group. The functional appliance (twin-block) will be applied for all patients, while the low-intensity pulsed ultrasound (LIPUS) 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, and the two groups will be compared.

Detailed Description
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Studies of the etiologic factors of Class II malocclusions recognize that most Class II malocclusions are a result of mandibular deficiency and not of maxillary excess. For many patients, especially adults, optimal overall results are best obtained using a combined orthodontic-surgical approach. However, treating such cases early while the patient is still growing, using mandibular propulsive functional appliances, can produce satisfactory improvement in the facial esthetics, and minimizes the need for surgical intervention in many cases. Ultrasound (US), a form of mechanical energy that is transmitted through and into biological tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used widely in medicine as a therapeutic, operative and diagnostic tool. Therapeutic US, and some operative US. Previous studies on animals have found that therapeutic ultrasound (US) can stimulate and enhance mandibular growth when applied during the active growth period. This study will evaluate the effect of low-intensity pulsed ultrasound (LIPUS) on the growth of mandible and the duration of functional treatment. Twin-block will be applied to the two groups. While the control group will receive the twin-block only, the experimental group will receive the twin-block combined with low-intensity pulsed ultrasound (LIPUS) on Temporomandibular joint (TMJ) region. Cephalometric radiographs will be obtained before and after functional treatment to evaluate the dento-skeletal changes.

Official Title
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Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment 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
* Other: LIPUS (Low-intensity pulsed ultrasound)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Angle class II malocclusion because of mandibular retrognathia O.J > 5 , SNB < 78 Patient during growth spurt Exclusion Criteria: TMJ disorders 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<br>The patients in this control group will be treated using the Twin-block appliance. | Device: Twin-block<br>* Functional treatment will be achieved using the Twinblock appliance<br>|
| Experimental: Twin-block combined with LIPUS<br>The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound). | Device: Twin-block<br>* Functional treatment will be achieved using the Twinblock appliance<br>Other: LIPUS (Low-intensity pulsed ultrasound)<br>* Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )<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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Low-intensity pulsed ultrasound, Twin-block, Functional treatment