NCT02290158

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 8, 2015

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

October 26, 2014

Last Update Submit

December 7, 2015

Conditions

Keywords

treatment outcomesMalocclusion/therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Line Smile

    Until 7 days after orthodontic appliances are removed

  • Arch Smile

    Until 7 days after orthodontic appliances are re

Study Arms (2)

Orthodontic finishing

ACTIVE COMPARATOR

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

Other: Finishing Protocol

No orthodontic finishing

NO INTERVENTION

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

Interventions

Students education, cast models and Panoramic X-ray assessment, brackets reposition and frequent clinical evaluation.

Orthodontic finishing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniersidad de Antioquia

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asociated Pofessor

Study Record Dates

First Submitted

October 26, 2014

First Posted

November 13, 2014

Study Start

June 1, 2013

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

December 8, 2015

Record last verified: 2014-11

Locations