Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway

Study Overview
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Brief Summary
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This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.

Detailed Description
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The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.

Official Title
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Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial

Conditions
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ClassII Division 1 Malocclusion, Mandibular Retrognathism

Intervention / Treatment
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* Device: Twin Block
* Device: Fixed orthodontic appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletal class II division 1 malocclusion due to mandibular retrognathism. Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4. Overjet ≥ 6 mm. Patient in circumpubertal stage CVM2 and CVM3. Exclusion Criteria: History of orthodontic treatment. Presence of craniofacial anomalies or TMJ disorders. Systemic problems that may affect craniofacial growth. Abnormal oral habits.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Twin block<br>Removable Functional appliance | Device: Twin Block<br>* Functional appliance<br>|
| Active Comparator: Fixed appliance<br>Preadjusted fixed appliance | Device: Fixed orthodontic appliance<br>* Braces<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharyngeal airway volume | CBCT images will be used to measure the pharyngeal airway volume in mm3 | One year | 
| Nocturnal breathing | Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum expiratory pressure | Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O. | One year | 
| Craniofacial changes | Lateral cephalometric images extracted from the CBCT images will be used to measure linear (mm) skeletal, dental and soft tissue changes of maxilla and mandible. | One year | 
| Craniofacial changes | Lateral cephalometric images extracted from the CBCT images will be used to measure angular (º) skeletal, dental and soft tissue changes of maxilla and mandible. | One year |