Effects of a Finishing Protocol Implementation in Orthodontic Patients

Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290158
• Other study ID #: BACAZA1
• Status: Completed
• Phase: N/A
• First received: October 26, 2014
• Last updated: December 7, 2015
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2014
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Other:
• Finishing Protocol
Students education, cast models and Panoramic X-ray assessment, brackets reposition and frequent clinical evaluation.

Locations

Country	Name	City	State
Colombia	Uniersidad de Antioquia	Medellin	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until 7 days after orthodontic appliances are removed	Yes
Secondary	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	Until 7 days after orthodontic appliances are removed	Yes
Secondary	Arch Smile	Relationship between incisor borders and upper lower lip border in an smiling photo	Until 7 days after orthodontic appliances are re	Yes