Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients

Study Overview
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Brief Summary
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Early orthodontic treatment of Class III malocclusions with skeletal and dentoalveolar imbalances, represents a continuous dilemma. This difficulty starts from their meticulous diagnosis and treatment planning till reaching satisfactory results and finally stability. Some appliances could be used to correct growing skeletal Class III patients, improving the skeletal and dentoalveolar relationships, creating proper conditions for final orthodontic treatment, more importantly avoiding surgery. These appliances remove patient compliance from the equation.

Detailed Description
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Aim of the work: Evaluate the skeletal, dentoalveolar and soft tissue effects of two different force application systems which are the pulling force (CS 2000® appliance/ CS appliance) and the pushing force (Reversed Forsus fatigue-resistant device/ RF appliance). Materials and methods: A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty three growing skeletal Class III patients (9-11 years) will be recruited upon a lateral cephalometric x-ray. Subjects complying with the inclusion criteria will be randomly assigned using a computer-generated list to one of the three groups Group I: Eleven patients treated with CS2000 appliance, Group II: Eleven patients treated with reversed Forsus Fatigue Resistant device and Group III: control group of Eleven untreated patients with a ratio of 1:1:1 allocation. A CBCT will be made before installing the appliances. After gaining a 2 mm positive overjet or a 6 months period, alginate impressions will be poured and dental casts will be made. Photographs and CBCTs will also be performed to record the dentofacial effect of the used appliances. Keywords: Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device.

Official Title
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Three Dimensional Evaluation Of Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients (A Randomized Controlled Clinical Trial)

Conditions
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Malocclusion, Angle Class III

Intervention / Treatment
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* Other: CS 2000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 8 years to 11 years. Cervical vertebrae maturation index (CVMI 2 and 3) identified on the lateral cephalometric radiograph. Angle Class III molar relation. Skeletal class III ANB ranges between (-4) - (0). Wits appraisal ranges between (0) - (-5). Patients with good oral hygiene, and a healthy periodontal condition. Reversed over jet (-1) - (-6). Normal vertical growth pattern (SN/MP angle 28˚-38˚). Exclusion Criteria: A discrepancy between centric relation and maximum intercuspation. Patients who underwent previous orthodontic treatment. Patients currently receiving drug therapy that may affect orthodontic tooth movement. Congenitally missing teeth or extracted teeth. History of systemic disease or craniofacial syndromes or presence of cleft.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 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
Interventional Model Description: randomized controlled clinical trial, parallel design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CS 2000 appliance<br>treating growing skeletal Class III patients | Other: CS 2000<br>* treating growing Skeletal growing Class III patients<br>* Other names: Reversed Forsus Fatigue resistant appliance;|
| Active Comparator: Reversed Forsus Fatigue resistant appliance<br>treating growing skeletal Class III patients | Other: CS 2000<br>* treating growing Skeletal growing Class III patients<br>* Other names: Reversed Forsus Fatigue resistant appliance;|
| No Intervention: Control<br>A group of untreated skeletally growing class III patients will be recruited to account for the possible effects of growth in the treatment groups. This group matches the treated groups in malocclusion, stages of skeletal maturation, and mean observation period. Those patients will be treated after the period of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal readings angles | SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees | 6 months | 
| Skeletal readings percetanges | LAFH in percentage | 6 months | 
| Skeletal readings in millimeters | Wits appraisal in millimeters | 6 months | 
| Dental readings angles | U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees | 6 months | 
| Dental readings in millimeters | U1-NA millimeters L1-NB in millimeters. | 6 months | 
| Soft tissue readings in millimeters | UL- E plane in millimeters LL- E plane in millimeters | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in airway | difference in airway volume in cubic millimeters . | 6 months | 
| Changes in TMJ | anterior, posterior, superior and medial joint space in cubic milimeters. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device