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
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
-
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.