Occlusal Outcomes by OGS After a Finishing Protocol

Study Overview
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Brief Summary
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Evaluation of the effects of the implementation of a new finishing protocol in orthodontics patients

Detailed Description
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Patients who are being treated in the postgraduate orthodontic clinics and who meet the inclusion and exclusion criteria, will be subject to a detailed evaluation according to the OGS criteria and upon meeting the treatment completion criteria they will be placed an aligner with setup for 3 weeks. The scores obtained before and after the aligner will be compared with a historical control group The OGS score obtained for each group, will be compared and the impact of the protocol and the aligner will be evaluated

Official Title
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OGS Scores After the Use of a New Finishing Protocol

Conditions
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Malocclusion, Orthodontics

Intervention / Treatment
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* Device: T1 before aligner
* Other: T2 after the aligner
* Other: Historic control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who completed the active phase of the bimaxillary orthodontic treatment in the Orthodontics Postgraduate Program of the UdeA by criteria of the treating clinician, during 2014 - 2018 period were included. Patients treated by using the UDEA1 finishing protocol (GC) and the UDEA 2 (GE) finishing protocol, which included aligners. All patients must have standardized diagnostic records at the end of the finishing phase (cast models and panoramic X-Rays) and must accepted to participate in the study voluntarily Exclusion Criteria: Patients that require prosthetic, periodontal and / or surgical treatments or with systemic compromise that may influence the outcome of orthodontic treatment

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One historic control group (UDEA1)comparing with intervention group (UDEA2) ( before and after)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T1 Conventional treatment before aligner<br>T1 before aligner: Conventional orthodontic treatment patients before the essix aligner | Device: T1 before aligner<br>* The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)<br>|
| Experimental: T2 After essix aligner<br>T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time | Other: T2 after the aligner<br>* The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)<br>|
| Active Comparator: Historic control group<br>Conventional orthodontic treatment without finishing protocol UdeA2 | Other: Historic control group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OGS score | Calculation of the score of the Objective Grading System | Through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Finishing protocol, Aligner