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Effects of a Finishing Protocol Implementation in Orthodontic Patients

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Finishing Protocol
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring treatment outcomes, Malocclusion/therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who finish orthodontic treatment by orthodontic criteria
  • Receive finishing protocol
  • Accept and sign inform consent
  • Records ( Panoramic Xray and cast models) taken immediately or 7 days after orthodontic appliances are remove

Exclusion Criteria:

  • Patients who don't accept being at the study
  • Bad quality records
  • Prosthodontic, periodontic and surgical needs treatment after orthodontic treatment

Sites / Locations

  • Uniersidad de Antioquia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Orthodontic finishing

No orthodontic finishing

Arm Description

Patients receiving a complete orthodontic finishing protocol according to the ABO-OGS

Patients receiving orthodontic treatment without the finishing protocol according to the ABO-OGS

Outcomes

Primary Outcome Measures

ABO-OGS Total Score
Sum of 8 variables scores ( alignment, marginal ridge height, buccolingual inclination, overjet, interproximal contact, occlusal contacts, occlusal relationships, and root angulation ) 1: difference less than 1 mm, 2: difference between 1 and 2 mm, 3: difference bigger than 2 mm . Total score less than 20: Excellent , Total score between 20-30: Acceptable and Total Score: > 30 No acceptable

Secondary Outcome Measures

Line Smile
Gingival exposure in smiling photo: High: More than 2 mm of gingival exposure, Media: between 2 and O mm of gingival exposure , Low: Less than clinical crown
Arch Smile
Relationship between incisor borders and upper lower lip border in an smiling photo

Full Information

First Posted
October 26, 2014
Last Updated
December 7, 2015
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT02290158
Brief Title
Effects of a Finishing Protocol Implementation in Orthodontic Patients
Official Title
Effects of a Finishing Protocol Implementation on the American Board of Orthodontics - Objective Grading System Score in Patients of Orthodontic Postgraduate Program: A Quasiexperimental Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effects of a finishing protocol in orthodontic outcomes using ABO-OGS scores. Patients who finish orthodontic treatment and fulfill the inclusion and exclusion criteria receive a treatment using a finishing protocol and their scores are compare with 40 patients who don't receive a finishing protocol
Detailed Description
The phase of finishing is the most demanding and detailed of all phases of the orthodontic treatment. American Board of Orthodontics- Objective Grading system is a detailed and objective method that evaluates the quality of the final outcome of orthodontic treatment. In order to evaluate and compare the effects of a protocol implementation on the ABO-OGS scores, standardize cast models and Pan X-Ray from by convenience patients of Orthodontic Postgraduate Program of University of Antioquia who finish orthodontic treatment and receive the protocol are digitized, eight variables are evaluate and ABO-OGS score is calculate. A comparison with 40 no-protocol ABO-OGS scores by convenience-selected patients is done. The protocol includes an educate residents program about finishing problems , an standardized clinical and X-ray assessment , brackets reposition and frequent clinical evaluation. The percentage of the protocol implementation is calculate in every patient and reliability test is make . The descriptive analysis and the ABO-OGS score comparison is done by Pearson or Spearman correlation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
treatment outcomes, Malocclusion/therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orthodontic finishing
Arm Type
Active Comparator
Arm Description
Patients receiving a complete orthodontic finishing protocol according to the ABO-OGS
Arm Title
No orthodontic finishing
Arm Type
No Intervention
Arm Description
Patients receiving orthodontic treatment without the finishing protocol according to the ABO-OGS
Intervention Type
Other
Intervention Name(s)
Finishing Protocol
Intervention Description
Students education, cast models and Panoramic X-ray assessment, brackets reposition and frequent clinical evaluation.
Primary Outcome Measure Information:
Title
ABO-OGS Total Score
Description
Sum of 8 variables scores ( alignment, marginal ridge height, buccolingual inclination, overjet, interproximal contact, occlusal contacts, occlusal relationships, and root angulation ) 1: difference less than 1 mm, 2: difference between 1 and 2 mm, 3: difference bigger than 2 mm . Total score less than 20: Excellent , Total score between 20-30: Acceptable and Total Score: > 30 No acceptable
Time Frame
Until 7 days after orthodontic appliances are removed
Secondary Outcome Measure Information:
Title
Line Smile
Description
Gingival exposure in smiling photo: High: More than 2 mm of gingival exposure, Media: between 2 and O mm of gingival exposure , Low: Less than clinical crown
Time Frame
Until 7 days after orthodontic appliances are removed
Title
Arch Smile
Description
Relationship between incisor borders and upper lower lip border in an smiling photo
Time Frame
Until 7 days after orthodontic appliances are re

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who finish orthodontic treatment by orthodontic criteria Receive finishing protocol Accept and sign inform consent Records ( Panoramic Xray and cast models) taken immediately or 7 days after orthodontic appliances are remove Exclusion Criteria: Patients who don't accept being at the study Bad quality records Prosthodontic, periodontic and surgical needs treatment after orthodontic treatment
Facility Information:
Facility Name
Uniersidad de Antioquia
City
Medellin
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

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Effects of a Finishing Protocol Implementation in Orthodontic Patients

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