Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study

Study Overview
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Brief Summary
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Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases

Detailed Description
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Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance. the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4

Official Title
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Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study

Conditions
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Class II Malocclusion

Intervention / Treatment
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* Device: Mandibular Protraction Appliance
* Device: PowerScope Appliance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletal and dental class II malocclusion with mandibular retrognathia, SNB>= 4. Patients in cervical vertebral maturation index 3 -5. Age ranged from 13-16 years. Overjet ≥ 5 mm. Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars). Good oral hygiene and general health. No previous orthodontic treatment or jaw's surgery. Exclusion Criteria: Class I skeletal malocclusion periodontally compromised patient patients have systemic diseases interfering with orthodontic treatment

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 16 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
Interventional Model Description: 2 treatment groups, both have class II malocclusion
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mandibular Protraction Appliance<br>the first group that received Mandibular Protraction Appliance | Device: Mandibular Protraction Appliance<br>* Mandibular Protraction Appliance was installed on fixed orthodontic appliance<br>|
| Experimental: PowerScope Appliances<br>the first group that received PowerScope Appliances | Device: PowerScope Appliance<br>* PowerScope Appliance was installed on fixed orthodontic appliance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNA angle (on Cephalometric radiograph) | Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line) | 6 months | 
| SNB angle (on Cephalometric radiograph) | Anteroposterior postition of mandible in relation to the anterior cranial base (SN line) | 6 months | 
| ANB angle (on Cephalometric radiograph) | The relationaship between maxilla and mandible | 6 months | 
| Effective mandibular length (mm) (on Cephalometric radiograph) | the length of the mandible (change in length before and after treatment) | 6 months | 
| Mandibular plane angle (on Cephalometric radiograph) | the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line) | 6 months | 
| Maxillary incisors inclination (angle) (on Cephalometric radiograph) | The change of maxillary incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line) | 6 months | 
| Mandibular incisors inclination (angle) (on Cephalometric radiograph) | The change of mandibular incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper lip retrusion (mm) (on Cephalometric radiograph) | the amount of upper lip retrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points) | 6 months | 
| Lower lip protrusion (on Cephalometric radiograph) | the amount of lower lip protrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PowerScope, Mandibular Protraction Appliance