Condition category
Oral Health
Date applied
19/01/2001
Date assigned
19/01/2001
Last edited
07/09/2009
Prospective/Retrospective
Prospectively 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

G9901331

Study information

Scientific title

Acronym

Study hypothesis

The proposed study is a follow-up to an existing MRC funded study into orthodontic growth modification treatment for Class II skeletal malocclusion, which:
1. Investigated early orthodontic intervention compared to a control group
2. Compared two orthodontic appliances in later intervention

The proposed study aims to
1. Compare early treatment patients and controls after any subsequent treatment received, to evaluate the long-term benefits/drawbacks of treatment timing
2. Evaluate the long-term effects of the appliances in the existing study
3. Start a new trial to compare the effect of two types of post-treatment retention on Class II patients who have finished orthodontic growth modification treatment

ISRCTN61138858 - grant G9410454 preceded this trial.

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

Study 1: Early orthodontic treatment with Twin Block or untreated control
Study 2: Orthodontic treatment with a Twin Block or a Herbst appliance
Study 3: Orthodontic treatment with a Twin Block appliance randomised to fixed or removable orthodontic retention

ISRCTN61138858 - grant G9410454 preceded this trial.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Study 1
Children in the early group, already randomised to treatment or control, will be treated where necessary according to the protocol of the consultant. Records will be taken at the end of all treatment or after 5 years if there has been no treatment. The outcomes will be:
- Whether further treatment was needed.
- If treatment was needed.
- Duration of treatment.
- Did the treatment involve jaw surgery?
- The number of visits required to complete treatment.
- Dental change, recorded from study model analysis with the PAR index.
- Skeletal and Dental change, measured with cephalometric analysis.
- Change in patient perceptions with Piers Harris self-esteem measure.
- The cost of the treatment
- Trauma to the incisors?

Study 2
Patients already randomised to treatment with a Herbst or a Twin Block appliance (treatment now completed) will be followed up for a period of 5 years and the following outcome measures will be collected:
- Skeletal and dental change, measured with cephalometric analysis.
- Dental change, recorded from study model analysis with the PAR index.
- Change in patient perceptions with Piers Harris self-esteem measure.

Study 3
Patients finishing growth modification treatment with a Twin Block appliance will be randomised to two groups. One group will be given upper and lower removable retaining appliances, the other will have fixed retaining appliances fitted to the inside of their anterior teeth. Outcomes:
- Skeletal and dental change, measured with cephalometric analysis.
- Dental change, recorded from study model analysis with the PAR index.
- Change in patient perceptions with Piers Harris self-esteem measure.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/04/2001

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Studies 1 and 2 : Initial Dental overjet of greater than 7 mm; enrolment in the original Class II study.

Study 3: The patient has received Twin Block treatment followed by upper and lower fixed appliances; the original overjet was greater than or equal to 7 mm; any operator in the department provided treatment.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Study 1=160, Study 2=166, Study 3=160, Total=486

Participant exclusion criteria

Studies 1 and 2: Initial dental overjet of less than 7 mm; enrolment in the original Class II Study.

Study 3: Individuals with clefts of the lip and/or palate or any other suspected identifiable syndromes; people with midline diastema not caused by incisor proclination; people with hypodontia; treatment discontinued early/poor oral hygiene.

Recruitment start date

01/04/2001

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Dental Medicine and Surgery
Manchester
M15 6FH
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 6000

Sponsor type

University/education

Website

http://www.manchester.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

1. 2003 results of Study 1 in http://www.ncbi.nlm.nih.gov/pubmed/12970656
2. No publications for Study 2 and Study 3

Publication citations

  1. O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I, Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects., Am J Orthod Dentofacial Orthop, 2003, 124, 3, 234-43; quiz 339, doi: 10.1016/S0889540603003524.

Additional files

Editorial Notes