Occlusal Outcomes by OGS After a Finishing Protocol

NCT03714087 | Completed

• 1 other identifier: Finishing2
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Malocclusion; Orthodontics

Keywords

Finishing protocol; Aligner

Outcome Measures

Primary Outcomes (1)

• OGS score

  Calculation of the score of the Objective Grading System

  Through study completion, an average of 2 year

Study Arms (3)

T1 Conventional treatment before aligner

EXPERIMENTAL

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

Device: T1 before aligner

T2 After essix aligner

EXPERIMENTAL

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

Other: T2 after the aligner

Historic control group

ACTIVE COMPARATOR

Conventional orthodontic treatment without finishing protocol UdeA2

Other: Historic control group

Interventions

T1 before aligner DEVICE

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

T1 Conventional treatment before aligner

T2 after the aligner OTHER

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

Historic control group OTHER

Historic control group

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients that require prosthetic, periodontal and / or surgical treatments or with systemic compromise that may influence the outcome of orthodontic treatment

Sponsors & Collaborators

• Universidad de Antioquia: lead

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One historic control group (UDEA1)comparing with intervention group (UDEA2) ( before and after)

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: October 22, 2018
• Study Start: July 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 22, 2018

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share