The effectiveness of non-surgical orthodontic treatment for the treatment of severe class II growth anomalies
| ISRCTN | ISRCTN61138858 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61138858 |
| Secondary identifying numbers | G9410454 |
- Submission date
- 17/10/2000
- Registration date
- 17/10/2000
- Last edited
- 17/07/2012
- 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
Professor Kevin O'Brien
Scientific
Scientific
Department of Dental Medicine and Surgery
University Dental Hospital of Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To evaluate the effectiveness of different methods of orthodontic growth modification for the treatment of mandibular deficiency. The methods that are being compared are: (1) Early treatment with a Twin Block appliance and no treatment (2) Later treatment with a Herbst appliance or a Twin Block. This trial was continued by ISRCTN26364810 - grant G9901331. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dental |
| Intervention | Early treatment with a Twin Block appliance and no treatment. Later treatment with a Herbst appliance or a Twin Block. This trial was continued by ISRCTN26364810 - grant G9901331. |
| Intervention type | Other |
| Primary outcome measure | Dental and skeletal change, self esteem and patient preference |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/1997 |
| Completion date | 01/04/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Target number of participants | 480 Added 20/08/09: 2 years follow-up |
| Key inclusion criteria | Children with an overjet of greater than 7 mm |
| Key exclusion criteria | Craniofacial syndrome |
| Date of first enrolment | 01/04/1997 |
| Date of final enrolment | 01/04/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Dental Medicine and Surgery
Manchester
M15 6FH
United Kingdom
M15 6FH
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
