The influence of clasp design on twin block appliances outcome - a prospective randomised, controlled clinical trial
| ISRCTN | ISRCTN45965219 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45965219 |
| Secondary identifying numbers | N0188119744 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr MJ Trenouth
Scientific
Scientific
Consultant Orthodontist
Royal Preston Hospital
Sharoe Green Lane North
Fulwood
Preston
PR2 9HT
United Kingdom
| Phone | +44 (0)1772 523150 |
|---|---|
| michaeltrenouth@hotmail.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| 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(s) | Added May 2008: Preston and Chorley and South Ribble Research Ethics Committee on 03/07/2003 |
| 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 |
| Primary outcome measure | 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 study start date | 01/01/2003 |
| Overall study end date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 15 Years |
| Sex | Not Specified |
| Target number of participants | 102. Corrected May 2008: 52. Added October 2009: recruitment completed and analysis ongoing. |
| 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 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
- England
- United Kingdom
Study participating centre
Consultant Orthodontist
Preston
PR2 9HT
United Kingdom
PR2 9HT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Lancashire Teaching Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2012 | Yes | No |
