Effects of a Finishing Protocol Implementation in Orthodontic Patients

December 7, 2015 updated by: Alvaro Carvajal, Universidad de Antioquia

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Uniersidad de Antioquia

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Orthodontic finishing
Patients receiving a complete orthodontic finishing protocol according to the ABO-OGS
Other: Finishing Protocol
Students education, cast models and Panoramic X-ray assessment, brackets reposition and frequent clinical evaluation.
No Intervention: No orthodontic finishing
Patients receiving orthodontic treatment without the finishing protocol according to the ABO-OGS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ABO-OGS Total Score
Time Frame: Until 7 days after orthodontic appliances are removed
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
Until 7 days after orthodontic appliances are removed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Line Smile
Time Frame: Until 7 days after orthodontic appliances are removed
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
Until 7 days after orthodontic appliances are removed
Arch Smile
Time Frame: Until 7 days after orthodontic appliances are re
Relationship between incisor borders and upper lower lip border in an smiling photo
Until 7 days after orthodontic appliances are re

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

June 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 26, 2014

First Submitted That Met QC Criteria

November 8, 2014

First Posted (Estimate)

November 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2015

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BACAZA1

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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