Preventing oral cancer: a smoking cessation intervention in a dental setting for patients with potentially malignant lesions

ISRCTN	ISRCTN79674187
DOI	https://doi.org/10.1186/ISRCTN79674187
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Viv Binnie
Scientific

Level 8
Glasgow Dental School
378 Sauchiehall Street
Glasgow
G2 3JZ
United Kingdom

Phone	+44 (0)141 211 9802
Email	v.binnie@dental.gla.ac.uk

Study design	Randomised, controlled, two armed trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To detemine the feasibity of delivering two smoking cessation methodologies 5As (Ask, Advise, Assess, Assist, Arrange) and behavioural change counselling, to a cohort of patients who smoke and have been referred to an oral medicine department.
Ethics approval(s)	Ethics approval received from: 1. The Glasgow Area Dental Ethics Committee on the 23/12/2003 2. The West Glasgow Ethics Committee 2 on the 20/09/2005 (protocol amendment)
Health condition(s) or problem(s) studied	Potentially malignant oral lesions
Intervention	Interventions group received advice based on the 5As (Ask, Advise, Assess, Assist, Arrange) and Nicotene Replacement Therapy (NRT) and behaviour change counselling. Control group received treatment as usual.
Intervention type	Other
Primary outcome measure	1. Self reported quit rates 2. Validated by Carbon Monoxide (CO) and salivary cotinine
Secondary outcome measures	Self-reported changes in smoking behaviour, including reduction in cigarettes and increase in number and length of quit attempts.
Overall study start date	03/03/2004
Completion date	03/03/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	120-150
Key inclusion criteria	Patients who smoke, and have been referred with suspicious oral lesion.
Key exclusion criteria	Patients who have been diagnosed with oral cancer.
Date of first enrolment	03/03/2004
Date of final enrolment	03/03/2004

Level 8

Glasgow
G2 3JZ
United Kingdom

University of Glasgow (UK)
University/education

University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Research organisation

Action on Smoking and Health (ASH) Scotland (UK) (ref: S1-32/S2-18) - website: www.ashscotland.org.uk

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/05/2007		Yes	No