Prospective comparative study of affects of two functional appliances
| ISRCTN | ISRCTN52655400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52655400 |
| Secondary identifying numbers | N0514153013 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 14/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew DiBiase
Scientific
Scientific
East Kent Hospitals NHS Trust
Orthodontics Department
Kent & Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
| Phone | +44 (0)1227 783191 |
|---|
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 |
| Scientific title | |
| Study objectives | To study effects of treatment of patients with Class II DW I malocclusion with modified Clarke Twin block appliance and Bass Dynamax appliance. |
| Ethics approval(s) | East Kent Local Research Ethics Committee, 06/11/2008, ref: 08/H1103/66 |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | 2 appliance systems (Twin Block and Dynamax) |
| Intervention type | Other |
| Primary outcome measure | 1. Hard tissue changes from lateral cephalo mexric radiograph taken at start and end of treatment. 2. Soft tissue changes from 3D laser scans taken during treatment |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2004 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 200 patients awaiting treatment on orthodontic waiting lists to be allocated into one of the two groups. Inclusion criteria: 1. Class II division 1 malocclusion on a skeletal II base 2. Madibular retrongnathia contributing to the skeletal II base 3. Minimum overjet of 7mm 4. Male caucasians aged 12-14 years by Jan 1st 2003 5. Female caucasians aged 10-13 years by Jan 1st 2003 6. No history of orthodontic treatment 7. No permanent tooth extractions 8. No relevant medical history |
| Key exclusion criteria | If patients don't fit in to the inclusion criteria defined above then they were not included in the study. |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
East Kent Hospitals NHS Trust
Canterbury
CT1 3NG
United Kingdom
CT1 3NG
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
East Kent Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding
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 |
