A Randomised Clinical Trial: Conventional Ligation vs Figure of 8

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rachel Little, University of Birmingham
ClinicalTrials.gov Identifier:
NCT01771692
First received: January 16, 2013
Last updated: January 25, 2016
Last verified: January 2016
  Purpose

Fixed braces (appliances) are used to straighten the malalignment of teeth. There has been a lot of research into the factors that can affect the speed of alignment of teeth but there has been very little research on how different techniques of wire attachment to the brace (ligation) can affect this.

The randomised clinical trial of 100 patients aims to compare the speed of alignment of the lower (mandibular) front teeth (incisors) using two different techniques over a period of 12 weeks. Both techniques use the conventional small elastic rings (modules) that are placed over each metal square (bracket) but they will be tied in a different configuration for each group. We will also observe any differences in the distances between the corresponding teeth either side of the lower jaw for each group and the bracket failure rates.


Condition Intervention
Malocclusion
Other: Extraction
Other: Non extraction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Into the Effects of Different Ligation Techniques on Orthodontic Mandibular Incisor Alignment

Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • Little's irregularity index. [ Time Frame: up to12 weeks ] [ Designated as safety issue: No ]
    Mandibular incisor irregularity index reduction using Little's irregularity index.


Secondary Outcome Measures:
  • Intercanine width. [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
    Changes in intercanine widths between the two groups.


Other Outcome Measures:
  • Intermolar width. [ Time Frame: 0, 6, 12 weeks ] [ Designated as safety issue: No ]
    Changes in intermolar widths between the two groups.

  • Bracket failure rate. [ Time Frame: 0,6,12 weeks ] [ Designated as safety issue: No ]
    Compare orthodontic bracket failure rates between the two groups.


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional ligation
Modules ligated in a conventional manner (figure of 0)
Other: Extraction
Extraction of teeth in the lower arch as part of the orthodontic treatment plan
Other: Non extraction
Non extraction in the lower arch as part of the orthodontic treatment plan
Active Comparator: Figure of 8 ligation
Modules ligated in a figure of 8 configuration
Other: Extraction
Extraction of teeth in the lower arch as part of the orthodontic treatment plan
Other: Non extraction
Non extraction in the lower arch as part of the orthodontic treatment plan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients at Burton Hospital
  • 12-15 years of age at the start of treatment
  • No medical contraindications
  • Permanent dentition
  • Mandibular incisor irregularity of 5-10mm (using Little's irregularity index)
  • No other therapeutic intervention e.g. elastics, coils
  • Informed consent gained

Exclusion Criteria:

  • Presence of a craniofacial syndrome
  • Patients already participating in a research study
  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: NCT01771692

Locations
United Kingdom
Queen's Hospital, Burton Hospitals NHS Foundation Trust
Burton upon Trent, Staffordshire, United Kingdom, DE13 0RB
Sponsors and Collaborators
Rachel Little
Investigators
Study Director: David J Spary, BDS LDS FDS DOrth FDS Orth Burton Hospitals Foundation Trust
  More Information

Responsible Party: Rachel Little, Specialty Registrar in Orthodontics, University of Birmingham
ClinicalTrials.gov Identifier: NCT01771692     History of Changes
Other Study ID Numbers: LIT001 
Study First Received: January 16, 2013
Last Updated: January 25, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Birmingham:
Orthodontics

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 28, 2016