Therapeutic Effects of Class II Elastics on Aligners.

Study Overview
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Brief Summary
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The objective is to compare the dento-alveolar therapeutic effects of wearing class II inter-arch traction elastics on aligners versus multi-brackets in an adult population. The principal hypothesis is no significant difference in therapeutic effects of using inter-arch elastics on aligners versus multi-brackets.

Detailed Description
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It is a non-interventional research involving the human person, research on existing data and / samples in the field of dentofacial orthopedics. This study analyzes the effects of rubber bands when combined with aligners in adult patients. This is a comparative retrospective study of radiographs and casts before and after orthodontic treatment. The patients studied are in Angle class II and adults. Two groups are analysed: patients treated with fixed (vestibular multi-attachment) and removable (Invisalign-type aligners) appliances.

Official Title
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Therapeutic Effects of Class II Elastics on Aligners Versus Fixed-appliance in Adult Patients: Retrospective Study.

Conditions
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Malocclusion, Angle Class II

Intervention / Treatment
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* Combination Product: Aligner and inter-arch elastics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CVM stage 5 on lateral teleradiography (end of growth) Angle Class II Treatments with rubber bands for inter-arch traction End of treatment in class I Exclusion Criteria: Incomplete data Treatment with extractions, mini-screws, mini-plate or ortho-surgical treatment Dental agenesis (excluding wisdom teeth) Cranial-facial syndromes

Ages Eligible for Study
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Minimum Age: 13 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clear aligner<br>Patient with class II malocclusion, treated with class II elastics on aligners | Combination Product: Aligner and inter-arch elastics<br>* Correction of class II malocclusion by class II elastics on clear aligners<br>|
| Fixed appliance<br>Patient with class II malocclusion, treated with class II elastics on fixed appliance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IMPA Mandibular incisor angle (degrees) | Angle between the mandibular plane and the lower incisor axis: position of the lower incisor in relation to the mandible | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sex | Sex | 1 month | 
| Duration of treatment | Treatment time duration in month | 24 months | 
| Change in interproximal dental size | Interproximal size in mm | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in skeletal sagittal pattern ANB angle | Cephalometric measurements : angle between A, Na (nasion) and B in degrees | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in skeletal sagittal pattern Ao-Bo | Cephalometric measurements : mesure in mm between Ao and Bo | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in skeletal vertical pattern : FMA | Cephalometric measurements : angle in degrees between franckfort plan and mandibular plan. | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in skeletal vertical pattern : Sn Gogn | Cephalometric measurements : angle in degrees between SN and GoGn | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in faciale anterior height | Cephalometric measurements of faciale anterior height | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in faciale posterior height | Cephalometric measurements of faciale posterior height | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in index Faciale height | Cephalometric measurements, index HFP (faciale posterior heigth)/ HFA (faciale anterior height) | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in nterincisal angle | Cephalometric measurements : measurement between manxillary and mandibular incisors. | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in plan of occlusion | Cephalometric measurements : angle between SN and Op | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Age at the beginning of treatment | Age | 1 month | 
| Age at the end of treatment | Age | 24 months | 
| Change in von Spee curve | Measurements on impressions : it is the average of the distance between the highest point of the deepest cusp and the occlusal plane. | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in overall crowding | Measurements on impressions : comparison of the sum of the mesiodistal diameters of 35 to 45 and the arch perimeter from the mesial face of 36 to the mesial face of 46. | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in overjet | Measurements on impressions : in mm | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in overbite | Measurements on impressions : in mm | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in arch length | Measurements on impressions : distance between inter incisal point and mesiale face of 6. | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| CHange in class II quantity | Measurements on impressions : inter canine and inter molar relations | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in space required | Measurements on impressions : sum of all mesiodistal diameter. | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in inter canine distance | Measurements on impressions : distance between the canine in mm | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in inter premolar distance | Measurements on impressions : distance between the premolars | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 
| Change in inter molar distance | Measurements on impressions : distance between the molars | First : just before the beginning of treatment; Second : just after the end of orthodontic treatment. An average of 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aligner, inter-arch elastic, orthodontic, class II malocclusion, adult, clear aligner, orthodontic appliance, Invisalign, class II elastics, angle class II malocclusion