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
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