A Randomised Clinical Trial: Conventional Ligation vs Figure of 8

October 25, 2016 updated by: Rachel Little

A Study Into the Effects of Different Ligation Techniques on Orthodontic Mandibular Incisor Alignment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research protocol has been devised by Rachel Little (Specialty Registrar in Orthodontics), under the supervision of Mr David Spary (Consultant in Orthodontics) and Dr Ashish Dhopatkar (Head of Orthodontics, Birmingham Dental School).

Purpose:

In this study I intend to find out whether friction plays a part in lower incisor alignment by comparing different ligation techniques. If I can show that the speed of alignment is affected by different techniques, this will be an important finding for orthodontic treatment.

Aims:

This study aims to determine whether increased friction caused by ligation with figure of eight modules effects the speed of lower incisor alignment.

Recruitment and consent:

100 orthodontic patients (n=50 per group) who have attended a new patient clinic at Burton Hospital and who require correction for the malalignment of their teeth with a fixed appliances will be selected. Potential participants will be invited to take part in the study and will be given verbal and written information. If they agree to participate, written consent will be obtained. All patients will be competent and capable of making the decision. All patients in this study will be under 16 years of age, and so parental/legal guardian consent will be obtained. The patients will be able to withdraw from the study at any time, should they not wish to continue participating.

Method:

Participants will be randomly allocated to either the conventional module group (figure of O) or the figure of 8 module group, following consent for participation in the trial. Randomisation will use the method of block randomisation. Allocation will be undertaken by a non-clinician.

The plan is to use the study models (replica of the patient's teeth made out of plaster) from the pre treatment records as the baseline data then take an additional mould (impression) of the lower teeth only at each of the participants normal orthodontic appointments at six and twelve weeks after the appliances have been put on.

All measurements required will be taken from these study models using digital callipers, after the impressions have been cast in the laboratory.

Benefits of treatment:

• Improved appearance and function of the teeth

Risks of treatment:

  • Tooth decay and gum disease (this can be prevented with good oral hygiene and low sugar intake)
  • Discomfort
  • Breakages
  • Relapse (if retainers are not worn after the fixed appliances are removed)
  • Root shortening

Confidentiality:

The study models that will be analysed will be stored in the patient's model box along with their notes in a locked office.

At no point during this research will personal details be disclosed to any persons not directly involved with providing orthodontic care.

Conflict of interest:

No conflict of interest is known or expected to arise during this study.

At the end of the study:

A summary sheet of the findings of this study will be made available to participants on request.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Staffordshire
      • Burton upon Trent, Staffordshire, United Kingdom, DE13 0RB
        • Queen's Hospital, Burton Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Little's irregularity index.
Time Frame: up to12 weeks
Mandibular incisor irregularity index reduction using Little's irregularity index.
up to12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intercanine width.
Time Frame: 0, 6, 12 weeks
Changes in intercanine widths between the two groups.
0, 6, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intermolar width.
Time Frame: 0, 6, 12 weeks
Changes in intermolar widths between the two groups.
0, 6, 12 weeks
Bracket failure rate.
Time Frame: 0,6,12 weeks
Compare orthodontic bracket failure rates between the two groups.
0,6,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rachel Little

Investigators

  • Study Director: David J Spary, BDS LDS FDS DOrth FDS Orth, Burton Hospitals Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 17, 2013

First Posted (ESTIMATE)

January 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIT001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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