Condition category
Mental and Behavioural Disorders
Date applied
16/11/2008
Date assigned
30/03/2009
Last edited
16/06/2016
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

Mrs Susi Caldwell

ORCID ID

Contact details

Department of Orthodontics & Oral Surgery
University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sponsor/protocol No.: 20080D001

Study information

Scientific title

A randomised controlled trial of smoking cessation instruction in teenage orthodontic patients

Acronym

Study hypothesis

Null hypothesis:
Smoking cessation instruction provided to teenage orthodontic patients will have no impact on quit rates of smoking patients, nor smoking uptake rates of non-smoking patients.

Ethics approval

Oldham Research Ethics Committee, 18/02/2009, ref: 09/H1011/1

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Smoking, malocclusion

Intervention

The smoking cessation instruction will be verbal from the orthodontist along with pictorial information. The orthodontist will discuss with the patient an information sheet containing facts regarding the effects of smoking on the mouth, face and teeth, as well pictures of such effects.

The control group of participants will receive their orthodontic treatment only (no interventions).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Smoking status is measured at 6 and 12 months.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/02/2009

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Orthodontic patients (both males and females) 11-18 years at start of study
2. About to start or undergoing orthodontic treatment with fixed or removable orthodontic appliances
3. Parental agreement to the child's participation in the study and that the child has full confidentiality regarding their smoking status (if child under 16)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

Lack of consent - parental or child

Recruitment start date

01/02/2009

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Orthodontics & Oral Surgery
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester NHS Foundation Trust (UK)

Sponsor details

c/o Dr Andrew Maines
R & D Directorate
Education & Research Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Sponsor type

Government

Website

http://www.uhsm.nhs.uk

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital of South Manchester NHS Foundation Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Burnley General Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Trafford General Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Tameside General Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Salford Royal Hospital

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

16/06/2016: No publications found, verifying study status with principal investigator.