A randomised controlled trial of smoking cessation advice and nicotene replacement therapy delivered by dental hygienists in a dental setting

ISRCTN	ISRCTN32222677
DOI	https://doi.org/10.1186/ISRCTN32222677
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 trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	To determine the feasibility and efficacy of a smoking cessation intervention, delivered by dental hygienists in a cohort of periodontal patients attending an outpatient hospital department.
Ethics approval(s)	Ethics approval received from the Glasgow Dental Hospital and School Area Dental Ethics Committee in January 2001.
Health condition(s) or problem(s) studied	Smoking addiction
Intervention	Intervention arm: smoking cessation advice based on the 5As (Ask, Advise, Assess, Assist, Arrange) and Nicotene Replacement Therapy (NRT) Control arm: usual care (very brief advice)
Intervention type	Other
Primary outcome measure	Self -reported quit rates validated by Carbon Monoxide (CO) and salivary cotinine
Secondary outcome measures	1. Changes in smoking behaviour including reduction in number of cigarettes (and change in cotinine levels), and increase in numbers of quit attempts
Overall study start date	01/04/2001
Completion date	01/04/2004

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	120
Key inclusion criteria	1. Adult (more than 16 years) smokers of at least ten cigarettes 2. Informed consent
Key exclusion criteria	1. Adult (more than 16 years) smokers of less than ten cigarettes 2. Currently receiving smoking cessation therapy elsewhere
Date of first enrolment	01/04/2001
Date of final enrolment	01/04/2004

Level 8

Glasgow
G2 3JZ
United Kingdom

University of Glasgow (UK)
University/education

University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

University/education

The University of Glasgow (UK) - covering the cost of cotinine analysis

No information available

Smoking Concerns (UK) - local NHS Stop smoking body, donating NRT

No information available

All other costs were covered internally by NHS departments taking part in the trial

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