Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

Study Overview
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Brief Summary
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Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency: A Randomized Clinical Trial

Detailed Description
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The main objective of the study is to evaluate the effects of the modified fixed TB on class 2 growing cases and to compare its effect to the conventional removable TB Research question Does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency? PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block O : Primary outcome: Overjet Secondary outcome: Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance Hypothesis: There is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception. 8. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.

Official Title
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Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

Conditions
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Malocclusion, Angle Class II, Mandible Small

Intervention / Treatment
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* Device: modified Fixed twinblock
* Device: removable twin block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees) Overjet ≥ 5 mm Growing patients (CVMS 3 or 4) Exclusion Criteria: Skeletally mature patients 15 years old or above Patients with normal mandible and only protruded upper incisors. Syndromic, cleft patients and patients with dental anomalies Previous orthopaedic or orthodontic treatment No sex predilection.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 15 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: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Removable twin block group<br>participants would receive conventional removable twin block for correction of class II malocclusion for 9 months | Device: removable twin block<br>* Conventional Removable Clark twin block myofunctional appliance<br>* Other names: R.T.B.;|
| Experimental: Fixed twin block group<br>participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months | Device: modified Fixed twinblock<br>* modified fixed twin block functional appliance, with cemented bands on the first molars<br>* Other names: F.T.B.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Over jet reduction | the horizontal distance between upper and lower incisors | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective mandibular length | distance from condylon to the Pogonion points | 9 months | 
| lower incisor inclination | inclination of lower incisors on the mandibular plane | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthodontics, orthopedics, myofunctional appliance, Twinblock