A randomised controlled trial to assess whether smoking cessation instruction provided by orthodontists to teenage orthodontic patients is beneficial

ISRCTN ISRCTN79526387
DOI https://doi.org/10.1186/ISRCTN79526387
Secondary identifying numbers Sponsor/protocol No.: 20080D001
Submission date
16/11/2008
Registration date
30/03/2009
Last edited
16/06/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Susi Caldwell
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial of smoking cessation instruction in teenage orthodontic patients
Study objectivesNull 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(s)Oldham Research Ethics Committee, 18/02/2009, ref: 09/H1011/1
Health condition(s) or problem(s) studiedSmoking, malocclusion
InterventionThe 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 typeOther
Primary outcome measureSmoking status is measured at 6 and 12 months.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/02/2009
Completion date30/06/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit11 Years
Upper age limit18 Years
SexBoth
Target number of participants200
Key inclusion criteria1. 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)
Key exclusion criteriaLack of consent - parental or child
Date of first enrolment01/02/2009
Date of final enrolment30/06/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University Hospital of South Manchester NHS Foundation Trust (UK)
Hospital/treatment centre

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

Website http://www.uhsm.nhs.uk
ROR logo "ROR" https://ror.org/00he80998

Funders

Funder type

Hospital/treatment centre

University Hospital of South Manchester NHS Foundation Trust

No information available

Burnley General Hospital

No information available

Trafford General Hospital

No information available

Tameside General Hospital

No information available

Salford Royal Hospital

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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