Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/12/2009
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

Prof Kevin O’Brien

ORCID ID

Contact details

Orthodontic Department
University Dental Hospital of Manchester
Higher Cambridge Street
Manchester
M15 6FH
United Kingdom
+44 (0)161 275 6793
kevin.obrien@man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI02-20

Study information

Scientific title

Acronym

Study hypothesis

This study was designed to discover whether it is possible to develop guidelines which are acceptable General Dental Practitioners (GDPs), for the referral of patients for orthodontic treatment and whether the guidelines have an effect on the number of appropriate referrals made. The guidelines were drawn up by a panel of clinicians providing secondary care, and GDPs from the Local Dental Committees using evidence derived from a literature search.

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

Other

Trial type

Other

Patient information sheet

Condition

Oral health/stomatognathic diseases

Intervention

General dental practices in Manchester and Stockport were allocated to one of two groups. One group received guidelines for the referral of patients to secondary orthodontic care, and the other did not receive any guidelines. Dissemination of the guidelines was intended to be carried out at a series of meetings with GDPs but acceptance for these was very low. Dissemination was carried out by post with follow up correspondence.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The main outcome measure was whether the referral was appropriate according to the guidelines that had been developed. This information came from a form completed by the clinician at the initial visit by the referred patient, and gave detailed information on the reason for the referral being appropriate or inappropriate. Questionnaires were also given to all GPs receiving the guidelines to ascertain their opinions about the content, usefulness etc of the guidelines.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1995

Overall trial end date

31/03/1998

Reason abandoned

Eligibility

Participant inclusion criteria

All referrals by GDPs in the two groups were included in the study. Information on these was collected from five hospitals in Manchester and Stockport, and from three specialist orthodontic practitioners and one community orthodontist.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/1995

Recruitment end date

31/03/1998

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthodontic Department
Manchester
M15 6FH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10816930

Publication citations

  1. Results

    O'Brien K, Wright J, Conboy F, Bagley L, Lewis D, Read M, Thompson R, Bogues W, Lentin S, Parr G, Aron B, The effect of orthodontic referral guidelines: a randomised controlled trial., Br Dent J, 2000, 188, 7, 392-397.

Additional files

Editorial Notes