Condition category
Oral Health
Date applied
07/12/2006
Date assigned
29/12/2006
Last edited
12/05/2011
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

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

http://www.gla.ac.uk/

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

  1. 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.

Additional files

Editorial Notes