Arch Dimension and Inclination of the Upper and Lower Incisors Changes

Study Overview
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Brief Summary
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It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. For this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. The parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA ridge analysis

Official Title
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Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets

Conditions
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Malocclusion, Angle Class I

Intervention / Treatment
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* Device: Carriere SLX® (Passive self-ligating braces)
* Device: Empower® (Interactive self-ligating braces)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete permanent dentition, except third molars. Class I malocclusion, determined by Angle ANB 2 plus or minus 2 Visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the WALA Ridge clinically presented by the patient. Little index with minimum Irregularity 4-6 mm. Patients with x-rays of initial profile and at the end of alignment and leveling in good condition. Exclusion Criteria: Models in poor condition that do not allow measurements. Patients who do not wish to participate in the study Patients with cleft lip and palate Patients with craniofacial anomalies Patients with previous orthodontic treatment

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 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: Orthodontic patients treated with brackets Carriere SLX®<br>Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX® | Device: Carriere SLX® (Passive self-ligating braces)<br>* Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment<br>|
| Active Comparator: Orthodontic patients treated with brackets Empower®<br>Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower® | Device: Empower® (Interactive self-ligating braces)<br>* Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisomaxillary angle | Angle formed by the palatal plane and the upper incisor | At the end of the alignment and leveling phase, an average of 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transverse development of the upper and lower jaws | Cuspal and basal intercanine distance | Each time wire is changed in the sequence suggested by the author, an average of 3 months | 
| Inclination of the lower incisor | Incisal mandibular plane angle | At the end of the alignment and leveling phase, an average of 8 months |