Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9410454
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Dental and skeletal change, self esteem and patient preference
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/1997
Overall trial end date
01/04/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Children with an overjet of greater than 7 mm
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
480
Added 20/08/09: 2 years follow-up
Participant exclusion criteria
Craniofacial syndrome
Recruitment start date
01/04/1997
Recruitment end date
01/04/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dental Medicine and Surgery
Manchester
M15 6FH
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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