Occlusal Outcomes by OGS After a Finishing Protocol

October 17, 2018 updated by: Alvaro Carvajal, Universidad de Antioquia

OGS Scores After the Use of a New Finishing Protocol

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T1 Conventional treatment before aligner
T1 before aligner: Conventional orthodontic treatment patients before the essix aligner
Device: 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)
Experimental: T2 After essix aligner
T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time
Other: 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)
Active Comparator: Historic control group
Conventional orthodontic treatment without finishing protocol UdeA2
Other: Historic control group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Antioquia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Finishing2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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