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A Randomised Clinical Trial: Conventional Ligation vs Figure of 8

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771692
First Posted: January 18, 2013
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rachel Little, University of Birmingham
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Into the Effects of Different Ligation Techniques on Orthodontic Mandibular Incisor Alignment

Resource links provided by NLM:


Further study details as provided by Rachel Little, University of Birmingham:

Primary Outcome Measures:
  • Little's irregularity index. [ Time Frame: up to12 weeks ]
    Mandibular incisor irregularity index reduction using Little's irregularity index.


Secondary Outcome Measures:
  • Intercanine width. [ Time Frame: 0, 6, 12 weeks ]
    Changes in intercanine widths between the two groups.


Other Outcome Measures:
  • Intermolar width. [ Time Frame: 0, 6, 12 weeks ]
    Changes in intermolar widths between the two groups.

  • Bracket failure rate. [ Time Frame: 0,6,12 weeks ]
    Compare orthodontic bracket failure rates between the two groups.


Enrollment: 120
Study Start Date: January 2013
Study Completion Date: May 2016
Primary Completion Date: January 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 16, 2013
First Posted: January 18, 2013
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Rachel Little, University of Birmingham:
Orthodontics

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases