A Comparison of the Effectiveness of Two Types of Myofunctional Appliances

Study Overview
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Brief Summary
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A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).

Detailed Description
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It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.

Official Title
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A Comparison of the Effectiveness of Two Types of Myofunctional Appliances: A Randomized Clinical Trial

Conditions
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Tooth Position Anomalies

Intervention / Treatment
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* Device: Myofunctional appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Growing children who need myofunctional appliance. Cl II div. 1 malocclusion. No previous orthodontic or orthopaedic treatments. Exclusion Criteria: Patients with systemic involvement. Congenital malformations such as cleft lip and palate. Facial deformities. Finger sucking habit will be excluded

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

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: Myobrace group<br>Myobrace appliance will be used for children who have Cl.II div.a malocclusion | Device: Myofunctional appliance<br>* Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance<br>|
| Experimental: Twin-block group<br>Twin-block appliance will be used for children who have Cl.II div.a malocclusion | Device: Myofunctional appliance<br>* Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentoskeletal changes | Evaluation of dentoskeletal and soft tissue changes following the treatment of growing children with myobrace and twin block appliances. Using cephalometric analysis to measure the angles including dental angles such as inter-incisal angle, in addition to skeletal angles such as SNA,SNB and ANB angles. | T1 at the start of treatment and T2 at the end of treatment around 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue changes | 2. Soft tissue changes using cephalometric radiographs including different angular measurement such as E-line and nasolabial angle (comparing the changes in the photographs at the beginning of the treatment and at the end of the treatment. | T1 at the start of treatment and T2 at the end of treatment around 9 months | 
| Patient satisfaction | 3.Patient satisfaction with both appliances will be investigated using a questionnaire at the end of the study (around 9 months) | At the end of treatment (around 9 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofunctional appliance, Myobrace., Twin-block, Cl II div I malocclusion