Occlusal Outcomes by OGS After a Finishing Protocol

Not Applicable

Completed

• Conditions: Orthodontics; Malocclusion
• Interventions: Other: T2 after the aligner; Device: T1 before aligner; Other: Historic control group

• Registration Number: NCT03714087
• Lead Sponsor: Universidad de Antioquia

Brief Summary

Evaluation of the effects of the implementation of a new finishing protocol in orthodontics patients

Detailed Description

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

Study Timeline

• Study Start: 2014-07
• Status Verified: 2017-06
• Primary Completion: 2018-03
• Study Completion: 2018-05
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2 After essix aligner	T2 after the aligner	T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time
T1 Conventional treatment before aligner	T1 before aligner	T1 before aligner: Conventional orthodontic treatment patients before the essix aligner
Historic control group	Historic control group	Conventional orthodontic treatment without finishing protocol UdeA2

Primary Outcome Measures

Name	Time	Method
OGS score	Through study completion, an average of 2 year	Calculation of the score of the Objective Grading System