Condition category
Oral Health
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
31/03/2016
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

Miss Nikki Atack

ORCID ID

Contact details

Department of Orthodontics
Taunton & Somerset Hospital
Musgrove Park
Taunton
TA1 5DA
United Kingdom
+44 (0)1823 342136
nicola.atack@tst.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0249180873

Study information

Scientific title

A randomised controlled trial comparing conventional, active and passive self-ligating orthodontic bracket systems

Acronym

Study hypothesis

Do any of three routinely used brackets show superiority in terms of faster overall treatment time for patient and chairside time for clinicians?

Ethics approval

Somerset Research Ethics Committee (UK), REC ref: 06/Q2202/6, 08/032006.

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Oral Health: Orthodontics

Intervention

1. Standard GAC Omni bracket
2. System R GAC Omni bracket
3. Damon bracket

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Before September 2008: time to alignment, chairside time.
Modified September 2008: overall treatment time and chairside time.

Secondary outcome measures

Added September 2008: time to initial alignment and time for space closure.

Overall trial start date

01/03/2006

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant inclusion criteria

100 children under 18 requiring routine upper and lower fixed appliances following extraction.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Subjects with learning difficulties
2. Subjects who do not understand English
3. Subjects with incomplete labial segments, i.e. incisors or canines missing

Recruitment start date

01/03/2006

Recruitment end date

01/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Taunton & Somerset Hospital
Taunton
TA1 5DA
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

Taunton and Somerset Research and Development Consortium (UK)

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

Publication citations

Additional files

Editorial Notes

31/03/2016: No publications found, verifying study status with principal investigator