Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II

Study Overview
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Brief Summary
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The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

Detailed Description
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Patients will be clinically and radio-graphically examined for eligibility Eligible patients will be randomly assigned to one of two groups: Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block. Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

Official Title
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Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials

Conditions
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Mandibular Retrognathism, Mandibular Hypoplasia

Intervention / Treatment
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* Device: Modified Twin Block
* Device: Twin Block Appliance set to maximum bite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Growing Female Patient Skeletal Class II Malocclusion due to deficient mandible Overjet of 7 to 10 mm Short or normal vertical facial pattern No previous orthodontic nor orthopedic treatment Exclusion Criteria: Syndromes or Chronic Illness Skeletal Class II Malocclusion due to excessive maxilla Vertical skeletal growth pattern Habits

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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Female

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: Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Maximum Bite Advancement<br> | Device: Twin Block Appliance set to maximum bite<br>* a traditional twin block set to maximum bite advancement at start of treatment<br>|
| Experimental: Incremental Bite Advancement<br> | Device: Modified Twin Block<br>* a modified twin block design including jack screws to facilitate incemental advancement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses Skeletal and dentoalveolar changes in Mandible | Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in mandible. - changes that will be assesed include ( mandibular base length / mandibular antero posterior position in relation to cranial base/ Condylar position / lower incisor inclination to mandibular plane) | 8 Months | 
| To asses patient compliance | patient will answer a questionnaire at end of treatment | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses Skeletal and dentoalveolar changes in Maxilla | Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in maxilla Changes that will be assesed include ( maxillary base length / maxillary base antero posterior position in relation to cranial base / incisor inclination to palatial plane) | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Twin Block, Bite Advancement, Growth Modification