Condition category
Oral Health
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Robert T Lee

ORCID ID

Contact details

Orthodontics
Dental Institute
New Road
Whitechapel
London
E1 1BB
United Kingdom
+44 020 7377 7397
r.t.lee@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205186777

Study information

Scientific title

Acronym

Study hypothesis

In the UK most orthodontic treatment is carried out using fixed appliances or 'braces'. The first phase of fixed appliance orthodontic treatment is concerned principally with tooth alignment. Conventional fixed orthodontic brackets are cemented onto the teeth and attached to an arch wire using elastic ligatures. The teeth are then aligned using forces generated by the arch wire itself. Recently a ligature-free bracket system has been introduced. It has been suggested that reduced friction associated with this system can provide considerable benefits to the patient, principally because the teeth align more rapidly. We propose to investigate the nature of alignment of two fixed orthodontic bracket systems: Smart-Clip self ligating and Ormco Synthesis conventional siamese.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oral Health: Orthodontics

Intervention

Smart-Clip® ligature free brackets vs conventional pre-adjusted edgewise brackets (3M Unitek).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The ability of two fixed appliance orthodontic bracket systems to align crowded lower incisors. In particular lower incisor inclination and arch form changes will be compared.
Null hypothesis: there is no difference in lower incisor inclination, and angulation, and lower arch dimensions using self-ligating and conventional pre-adjusted edgewise brackets.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

22/09/2006

Overall trial end date

21/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients should be fit and well and not currently on any medication or suffering from any craniofacial syndrome. Medication could theoretically affect the connective tissues that remodel during orthodontic treatment
2. Children under 18 years
3. Lower incisor tooth crowding of up to 5mm as part of their malocclusion
4. A requirement for fixed orthodontic treatment on a non-extraction basis
5. More severely crowded dentitions often require the loss of premolar teeth to provide the necessary space for alignment of the dental arch

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. A complete overbite. Complete overbite might be expected to reduce rates of tooth alignment due to bracket interferences.
2. No incisor teeth completely excluded from the dental arch

Recruitment start date

22/09/2006

Recruitment end date

21/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthodontics
London
E1 1BB
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19409342
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19732667

Publication citations

  1. Results

    Fleming PS, DiBiase AT, Sarri G, Lee RT, Efficiency of mandibular arch alignment with 2 preadjusted edgewise appliances., Am J Orthod Dentofacial Orthop, 2009, 135, 5, 597-602, doi: 10.1016/j.ajodo.2007.06.014.

  2. Results

    Fleming PS, DiBiase AT, Sarri G, Lee RT, Comparison of mandibular arch changes during alignment and leveling with 2 preadjusted edgewise appliances., Am J Orthod Dentofacial Orthop, 2009, 136, 3, 340-347, doi: 10.1016/j.ajodo.2007.08.030.

Additional files

Editorial Notes