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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LUIS ALEJANDRO SANCHEZ URIBE, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01654419
First received: July 12, 2012
Last updated: July 30, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Malocclusion
Device: Class II elastics and Sliding Jig
Device: Class II elastic alone

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

Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • CT analysis for comparison of distal movement of upper canine and molar using class II elastics [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    CT were taken to compare the quantity of distal movement of the upper canine and molar using class II elastics with sliding jig


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: May 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Class II elastics alone
Use of class II elastics alone to correct class II dental malocclusions
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
Other Name: Elastics 3/16 heavy, 6oz. Impala (Ormco)
Experimental: Class II elastics with Sliding Jig
Class II elastics with Sliding Jig for correction of dental class II malocclusion
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
Other Names:
  • Archwire SS 16X22
  • Sliding Jig made in SS 17X25
  • Elastics 3/16 Heavy (6oz) Impala (Ormco)

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.

  Eligibility

Ages Eligible for Study:   13 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654419

Locations
Colombia
Faculty of Dentistry
Medellin, Antioquia, Colombia, 00000
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Principal Investigator: Luis A Sanchez, Professor Universidad de Antioquia
  More Information

Additional Information:
No publications provided

Responsible Party: LUIS ALEJANDRO SANCHEZ URIBE, PARTIAL TIME PROFESSOR IN ORTHODONTICS, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01654419     History of Changes
Other Study ID Numbers: 006-2010
Study First Received: July 12, 2012
Last Updated: July 30, 2012
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
sliding jig
Class II malocclusion
Distalization mechanics
Intermaxillary elastics

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 19, 2014