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Comparison of the Quantity of Distal Movement of the Upper Canine and Molar

Primary Purpose

Malocclusion

Status

Completed

Phase

Not Applicable

Locations

Colombia

Study Type

Interventional

Intervention

Class II elastics and Sliding Jig

Class II elastic alone

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring sliding jig, Class II malocclusion, Distalization mechanics, Intermaxillary elastics

Eligibility Criteria

13 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Root uncompleted
Dental Trauma
Dental Pathology

Sites / Locations

Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Class II elastics alone

Class II elastics with Sliding Jig

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics with sliding jig

Full Information

NCT ID

NCT01654419

First Posted

July 12, 2012

Last Updated

July 30, 2012

Sponsor

Universidad de Antioquia

1. Study Identification

Unique Protocol Identification Number

NCT01654419

Brief Title

Comparison of the Quantity of Distal Movement of the Upper Canine and Molar

Official Title

Comparison of 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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Antioquia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

To achieve a Class I canine relationship at the end of the alignment and leveling phase, different intraoral devices have been used. These include intermaxillary class II elastics, which retract the upper and protract the lower arch, generating extrusive forces at the anchorage sites. Its upper distalizing action is exerted to the canine bracket and transmitted through the posterior teeth where the upper molar does not receive a direct force. The sliding jig is an auxiliary addition that exerts force to the molar by an elastic hanged in a jig between the lateral and the canine in class II; such mechanism decreases the vertical adverse effects of the elastics wearing while directing the distalizing force to the molar. A randomized, unblinded, clinical trial comparing 30 units of analysis (hemi arches) in which were placed sliding jig or stand alone elastics were perform.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion

Keywords

sliding jig, Class II malocclusion, Distalization mechanics, Intermaxillary elastics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Class II elastics alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Class II elastics with Sliding Jig

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Class II elastics and Sliding Jig

Other Intervention Name(s)

Archwire SS 16X22, Sliding Jig made in SS 17X25, Elastics 3/16 Heavy (6oz) Impala (Ormco)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Class II elastic alone

Other Intervention Name(s)

Elastics 3/16 heavy, 6oz. Impala (Ormco)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics with sliding jig

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Class II dental malocclusion with alignment and leveling phase ended. Root completed not trauma Second molar erupted Third molar absent Dental and periodontal health Exclusion Criteria: Root uncompleted Dental Trauma Dental Pathology

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis A Sanchez, Professor

Organizational Affiliation

Universidad de Antioquia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Dentistry

City

Medellin

State/Province

Antioquia

ZIP/Postal Code

00000

Country

Colombia

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Quantity of Distal Movement of the Upper Canine and Molar

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