Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy

Study Overview
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Brief Summary
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Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: a group of patients in which participants will be undergo to the clear aligners with class ii elastics. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.

Detailed Description
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Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: a group of patients in which participants will be undergo to the clear aligners with class ii elastics. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics. phase Intervention/treatment Condition or disease Not applicable Other: clear aligners Technique with class ii elastics. Other: fixed multibracket appliances with class ii elastics Malocclusion Class ii Division 1 malocclusion

Official Title
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Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled

Conditions
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Malocclusion, Class II Malocclusion

Intervention / Treatment
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* Device: clear aligners
* Device: traditional treatment Fixed appliances with class II elastics.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with permanent occlusion at age 15-20 years. Patients with class II division I (half cusp or Less) with moderate overjet (2-4mm). Patients with normal or horizontal growth pattern. Mild crowding (_<2 mm) in maxillary and mandibular arch. Patient with satisfactory periodontal health and good oral hygiene No previous orthodontic treatment Comprehensive medical and dental history ruling out any systemic disease. Exclusion Criteria: Patients with periodontal disease. Patients with vertical growth pattern. Patients with missing or extracted teeth except third molar. Patients with temporomandibular joint disorder. Patients with Skeletal open bite. Patients with poor oral and gingival health Patients with neuromuscular disorder. Patients with severe skeletal class II.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental : clear aligners with class II elastics technique<br>clear aligners technique A group of patients in which participants will be undergo to clear aligners treatment with class II elastics ( clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar | Device: clear aligners<br>* clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar<br>|
| Experimental: : traditional treatment Fixed appliances with class II elastics.<br>A group of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed. | Device: traditional treatment Fixed appliances with class II elastics.<br>* Agroup of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the SNA angle | This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group | 
| change in the SNB angle | This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved(expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in ANB angle | This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in SN.POG angle | This angle the represents the position of the chin bone in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in the mandibular length [ | Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in SN.PP angle [ | This angle the represents the amount and direction of rotation of the upper jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in MP.SN angle | This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees. | T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in overjet | Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis. | : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) | 
| change in overbite | Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis. | T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group) |