Condition category
Oral Health
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/05/2013
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

Dr MJ Trenouth

ORCID ID

Contact details

Consultant Orthodontist
Royal Preston Hospital
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
+44 (0)1772 523150
michaeltrenouth@hotmail.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0188119744

Study information

Scientific title

Acronym

Study hypothesis

To discover if incorporating a Southend Clasp on the upper central incisors in the design of the Twin Block Appliance will eliminate or greatly reduce incisor retraction thereby enhancing mandibular advancement.

Ethics approval

Added May 2008: Preston and Chorley and South Ribble Research Ethics Committee on 03/07/2003

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

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

Random allocation of two alternative designs of twin block appliance, one with a Southend clasp on the upper central incisors and one without. The appliances are identical in all other aspects.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Added May 2008:
Angulation of the long axis of the upper incisor to the maxillary plane, as measured from a lateral cephalometric radiograph.

Secondary outcome measures

Added May 2008:
1. Angulation of the long axis of the lower incisor to the mandibular plane
2. Skeletal relationship as measured by angle ANB

Overall trial start date

01/01/2003

Overall trial end date

01/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 11-15 years
2. Added May 2008: with Class II division 1 malocclusion suitable for functional appliance therapy. The overjet had to be greater than 6mm and ANB angle greater than 4°.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

102. Corrected May 2008: 52. Added October 2009: recruitment completed and analysis ongoing.

Participant exclusion criteria

Added May 2008:
Patients with congenital syndromes, obvious asymmetry and prior appliance therapy were excluded.

Recruitment start date

01/01/2003

Recruitment end date

01/04/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Orthodontist
Preston
PR2 9HT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Lancashire Teaching Hospitals NHS Trust (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

1. 2010 conference proceedings: Trenouth MJ, et al. The influence of clasp design on twin block appliances outcome - a prospective randomised, controlled clinical trial. IFUNA 2010, 13th-16th October.
2. 2012 results in www.ncbi.nlm.nih.gov/pubmed/22433323

Publication citations

  1. Results

    Trenouth MJ, Desmond S, A randomized clinical trial of two alternative designs of Twin-block appliance., J Orthod, 2012, 39, 1, 17-24, doi: 10.1179/14653121226788.

Additional files

Editorial Notes