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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03714087
Other study ID # Finishing2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date May 2018

Study information

Verified date June 2017
Source Universidad de Antioquia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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)
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)
Historic control group


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Antioquia

Outcome

Type Measure Description Time frame Safety issue
Primary OGS score Calculation of the score of the Objective Grading System Through study completion, an average of 2 year
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