Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients

Study Overview
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Brief Summary
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The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess)

Detailed Description
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In this randomized trial, 2 groups will be included. The first group will receive an Infra-zygomatic Mini implant supported appliance. In the second group, the patient will receive a removable high pull headgear. the follow-up period will be 8 months or till class I canine or incisors relation is obtained. the assessment will be through a lateral cephalogram

Official Title
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Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: A Randomized Clinical Trial

Conditions
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Class II Division 1 Malocclusion

Intervention / Treatment
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* Device: Infra-zygomatic Mini Implant Supported Appliance
* Device: high pull head gear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Growing patients ( cervical vertebrae maturation stage cs2-cs3 ) Maxillary excess Minimum overjet 4 mm class II canines or incisors Increased incisal show at rest and on smiling Normal and increased vertical growth pattern No previous orthodontic treatment No congenitally messing teeth except third molars Exclusion Criteria: Inadequate incisal show Class II with deficient mandible and normal maxilla Patients with any syndrome Patients with horizontal growth pattern

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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Male

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: Mini Implant Supported Appliance<br>this group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month | Device: Infra-zygomatic Mini Implant Supported Appliance<br>* leveling and alignment of the four maxillary incisors infra zygomatic mini-implant will be placed bilaterally wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch a heavy arch wire engaging the 4 incisors will be attached to the wire frame work orthopedic force will be delivered from the mini-implants to the wire frame work<br>|
| Active Comparator: Headgear<br>this group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month | Device: high pull head gear<br>* acrylic maxillary splint is made with flying tubes high pull head gear is adapted to be inserted in the flying tubes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anteroposterior position changes of upper first molars. | Measurements on the lateral cephalogram | 8 months | 
| Anteroposterior position changes of the maxilla | Measurements on the lateral cephalogram | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertical position changes in maxilla | Measurements on the lateral cephalogram | 8 months | 
| Vertical position changes of upper first molars | Measurements on the lateral cephalogram | 8 months | 
| Position changes of upper incisors | Measurements on the lateral cephalogram | 8 months | 
| Anteroposterior skeletal changes in mandible | Measurements on the lateral cephalogram | 8 months |