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

Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654419
• Other study ID #: 006-2010
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: July 30, 2012
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Class II elastics and Sliding Jig
Class II elastics, 3/16 6 oz, used daily for 3 months 24 hours per day and sliding jig orthodontic device
• Class II elastic alone
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

Locations

Country	Name	City	State
Colombia	Faculty of Dentistry	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	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	Yes
Secondary	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	3 months	Yes