Back to resultsOcclusal Outcomes by OGS After a Finishing Protocol
Primary Purpose
Malocclusion, Orthodontics
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
T1 before aligner
T2 after the aligner
Historic control group
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Finishing protocol, Aligner
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
T1 Conventional treatment before aligner
T2 After essix aligner
Historic control group
Arm Description
T1 before aligner: Conventional orthodontic treatment patients before the essix aligner
T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time
Conventional orthodontic treatment without finishing protocol UdeA2
Outcomes
Primary Outcome Measures
OGS score
Calculation of the score of the Objective Grading System
Secondary Outcome Measures
Full Information
NCT ID
NCT03714087
First Posted
June 4, 2018
Last Updated
October 17, 2018
Sponsor
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT03714087
Brief Title
Occlusal Outcomes by OGS After a Finishing Protocol
Official Title
OGS Scores After the Use of a New Finishing Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Orthodontics
Keywords
Finishing protocol, Aligner
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One historic control group (UDEA1)comparing with intervention group (UDEA2) ( before and after)
Masking
Investigator
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T1 Conventional treatment before aligner
Arm Type
Experimental
Arm Description
T1 before aligner: Conventional orthodontic treatment patients before the essix aligner
Arm Title
T2 After essix aligner
Arm Type
Experimental
Arm Description
T2 after the aligner: Essix aligner appliance with setup for 3 weeks full time
Arm Title
Historic control group
Arm Type
Active Comparator
Arm Description
Conventional orthodontic treatment without finishing protocol UdeA2
Intervention Type
Device
Intervention Name(s)
T1 before aligner
Intervention Description
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
Intervention Name(s)
T2 after the aligner
Intervention Description
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
Intervention Name(s)
Historic control group
Primary Outcome Measure Information:
Title
OGS score
Description
Calculation of the score of the Objective Grading System
Time Frame
Through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Occlusal Outcomes by OGS After a Finishing Protocol
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