Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients

Study Overview
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Brief Summary
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The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction

Detailed Description
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Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla

Official Title
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Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial

Conditions
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Orthodontic Appliance Complication

Intervention / Treatment
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* Device: Intraoral protraction device
* Device: Extraoral protraction device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Growing Patient ( CVM2-CVM3 ) Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal < -0.3mm) Erupted upper and lower first permanent molars and permanent incisors Reverse overjet up to -4 mm Exclusion Criteria: History of previous orthodontic treatment Cleft lip/palate patients Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting). Patients with syndromes

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 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: Intraoral Protraction Technique<br>using intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander | Device: Intraoral protraction device<br>* Use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol<br>|
| Active Comparator: Extraoral Protraction Technique<br>using facemask for maxillary protraction after ALT-RAMEC protocol | Device: Extraoral protraction device<br>* Facemask which is an extraoral appliance used for maxillary protraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxillary skeletal changes | using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA) | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mandibular skeletal changes | using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB) | 8 months | 
| Maxillary and Mandibular dental changes | using lateral cephalometric x-ray to measure changes using angular measurements in degrees (U1/Palatal plane ,L1/Mandibular plane) | 8 months |