Contact information
Type
Scientific
Primary contact
Dr Viv Binnie
ORCID ID
Contact details
Level 8
Glasgow Dental School
378 Sauchiehall Street
Glasgow
G2 3JZ
United Kingdom
+44 (0)141 211 9802
v.binnie@dental.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
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)
Study design
Randomised, controlled, two armed trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
03/03/2004
Overall trial end date
03/03/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who smoke, and have been referred with suspicious oral lesion.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
120-150
Participant exclusion criteria
Patients who have been diagnosed with oral cancer.
Recruitment start date
03/03/2004
Recruitment end date
03/03/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Level 8
Glasgow
G2 3JZ
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
University Avenue
Glasgow
G12 8QQ
United Kingdom
+44 (0)141 339 8855
p.ellis@gla.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Action on Smoking and Health (ASH) Scotland (UK) (ref: S1-32/S2-18) - website: www.ashscotland.org.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
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17475005
Publication citations
-
Results
Binnie VI, McHugh S, Jenkins W, Borland W, Macpherson LM, A randomised controlled trial of a smoking cessation intervention delivered by dental hygienists: a feasibility study., BMC Oral Health, 2007, 7, 5, doi: 10.1186/1472-6831-7-5.