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Effects of a Finishing Protocol Implementation in Orthodontic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290158
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : December 8, 2015
Sponsor:
Information provided by (Responsible Party):
Alvaro Carvajal, Universidad de Antioquia

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

Condition or disease Intervention/treatment Phase
Malocclusion Other: Finishing Protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290158


Locations
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Colombia
Uniersidad de Antioquia
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
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Responsible Party: Alvaro Carvajal, Asociated Pofessor, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT02290158    
Other Study ID Numbers: BACAZA1
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: November 2014
Keywords provided by Alvaro Carvajal, Universidad de Antioquia:
treatment outcomes
Malocclusion/therapy
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases