Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
14/03/2014
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

Dr Andrew DiBiase

ORCID ID

Contact details

East Kent Hospitals NHS Trust
Orthodontics Department
Kent & Canterbury Hospital
Ethelbert Road
Canterbury
CT1 3NG
United Kingdom
+44 (0)1227 783191

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0514153013

Study information

Scientific title

Acronym

Study hypothesis

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

East Kent Local Research Ethics Committee, 06/11/2008, ref: 08/H1103/66

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Oral Health

Intervention

2 appliance systems (Twin Block and Dynamax)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2004

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

If patients don't fit in to the inclusion criteria defined above then they were not included in the study.

Recruitment start date

01/10/2004

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Kent Hospitals NHS Trust
Canterbury
CT1 3NG
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

East Kent Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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