NCT01654419

Brief Summary

THE PURPOSE OF THE STUDY IS COMPARE THE QUANTITY OF DISTAL MOVEMENT OF THE UPPER CANINE AND MOLAR USING CLASS II ELASTICS WITH AND WITHOUT SLIDING JIG IN A PERIOD OF 3 MONTHS

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

July 12, 2012

Last Update Submit

July 30, 2012

Conditions

Malocclusion

Keywords

sliding jigClass II malocclusionDistalization mechanicsIntermaxillary elastics

Outcome Measures

Primary Outcomes (1)

  • CT analysis for comparison of distal movement of upper canine and molar using class II elastics

    CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics alone.

    3 months

Secondary Outcomes (1)

  • CT analysis for comparison of distal movement of upper canine and molar using class II with Sliding Jig

    3 months

Study Arms (2)

Class II elastics alone

ACTIVE COMPARATOR

Use of class II elastics alone to correct class II dental malocclusions

Device: Class II elastic alone

Class II elastics with Sliding Jig

EXPERIMENTAL

Class II elastics with Sliding Jig for correction of dental class II malocclusion

Device: Class II elastics and Sliding Jig

Interventions

Class II elastics and Sliding JigDEVICE

Class II elastics, 3/16 6 oz, used daily for 3 months 24 hours per day and sliding jig orthodontic device

Also known as: Archwire SS 16X22, Sliding Jig made in SS 17X25, Elastics 3/16 Heavy (6oz) Impala (Ormco)
Class II elastics with Sliding Jig
Class II elastic aloneDEVICE

Elastics Class II alone, used 24 hours per day for 3 months from the hook of the upper canine to the first lower molar hook

Also known as: Elastics 3/16 heavy, 6oz. Impala (Ormco)
Class II elastics alone

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Class II dental malocclusion with alignment and leveling phase ended.
  • Root completed not trauma
  • Second molar erupted
  • Third molar absent
  • Dental and periodontal health

You may not qualify if:

  • Root uncompleted
  • Dental Trauma
  • Dental Pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Medellín, Antioquia, 00000, Colombia

Location

MeSH Terms

Conditions

MalocclusionOverbite

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesMalocclusion, Angle Class II

Study Officials

  • Luis A Sanchez, Professor

    Universidad de Antioquia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PARTIAL TIME PROFESSOR IN ORTHODONTICS

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 31, 2012

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

May 1, 2012

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

CO(1)