Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Detailed Description
-----------------
in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Official Title
-----------------
Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial

Conditions
-----------------
Class II Division 1 Malocclusion

Intervention / Treatment
-----------------
* Device: twin block appliance
* Device: modified twin block appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Skeletal Class II relationship (ANB > 4°). Mandibular retrognathy (SNB < 78°). Overjet ≥ 5 mm. Minimal crowding in dental arches (≤4 mm). Class II molar relation. Growing female patients. Patients with CMV3 maturation stage of the cervical verbrae. Exclusion Criteria: No history of orthodontic treatment either prior to or during functional Appliance therapy. Posterior cross bites or severe maxillary transverse deficiency. Severe facial asymmetry determined by clinical or radiographical examination. Poor oral hygiene. Systemic diseases that may affect the orthodontic treatment results. Patients past their peak growth spurt.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: twin block appliance<br>this group will receive conventional twin block appliance and followed up every month for 9 months. | Device: twin block appliance<br>* a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)<br>* Other names: mandibular functional appliance;|
| Experimental: modified twin block appliance group<br>modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months | Device: modified twin block appliance<br>* a convetional twin block functional appliance that enhances mandibular growth in growing patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| enhancing mandibular skeletal growth | it will be assessed by measuring the incremental growth by quick ceph (mm) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dentoalveolar changes | quick ceph (mm) | 9 months | 
| Improvement of soft tissue profile | quick ceph (mm) | 9 months | 
| Patient's compliance | table chart (no of hours/day) | 9 months |