NCT01771692

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

January 16, 2013

Last Update Submit

October 25, 2016

Conditions

Malocclusion

Keywords

Orthodontics

Outcome Measures

Primary Outcomes (1)

  • Little's irregularity index.

    Mandibular incisor irregularity index reduction using Little's irregularity index.

    up to12 weeks

Secondary Outcomes (1)

  • Intercanine width.

    0, 6, 12 weeks

Other Outcomes (2)

  • Intermolar width.

    0, 6, 12 weeks

  • Bracket failure rate.

    0,6,12 weeks

Study Arms (2)

Conventional ligation

ACTIVE COMPARATOR

Modules ligated in a conventional manner (figure of 0)

Other: ExtractionOther: Non extraction

Figure of 8 ligation

ACTIVE COMPARATOR

Modules ligated in a figure of 8 configuration

Other: ExtractionOther: Non extraction

Interventions

ExtractionOTHER

Extraction of teeth in the lower arch as part of the orthodontic treatment plan

Conventional ligationFigure of 8 ligation
Non extractionOTHER

Non extraction in the lower arch as part of the orthodontic treatment plan

Conventional ligationFigure of 8 ligation

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients at Burton Hospital
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's Hospital, Burton Hospitals NHS Foundation Trust

Burton-on-Trent, Staffordshire, DE13 0RB, United Kingdom

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • David J Spary, BDS LDS FDS DOrth FDS Orth

    Burton Hospitals Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialty Registrar in Orthodontics

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2016

Study Completion

May 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

GB(1)