Condition category
Oral Health
Date applied
17/10/2000
Date assigned
17/10/2000
Last edited
17/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Kevin O'Brien

ORCID ID

Contact details

Department of Dental Medicine and Surgery
University Dental Hospital of Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Publication citations

Additional files

Editorial Notes