Occlusal Outcomes by OGS After a Finishing Protocol

NCT ID: NCT03714087

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2018-05-31

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

Conditions

Malocclusion; Orthodontics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

T1 Conventional treatment before aligner

T1 before aligner: Conventional orthodontic treatment patients before the essix aligner

Group Type: EXPERIMENTAL

T1 before aligner

Intervention Type: DEVICE

The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)

T2 After essix aligner

T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time

Group Type: EXPERIMENTAL

T2 after the aligner

Intervention Type: OTHER

The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)

Historic control group

Conventional orthodontic treatment without finishing protocol UdeA2

Group Type: ACTIVE_COMPARATOR

Historic control group

Intervention Type: OTHER

Interventions

T1 before aligner

The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)

Intervention Type: DEVICE

T2 after the aligner

The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)

Intervention Type: OTHER

Historic control group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

Alvaro Carvajal

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Finishing2

Identifier Type: -

Identifier Source: org_study_id