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
Protocol serial number N/A
Sponsor University of Glasgow (UK)
Funders The University of Glasgow (UK) - covering the cost of cotinine analysis, Smoking Concerns (UK) - local NHS Stop smoking body, donating NRT, All other costs were covered internally by NHS departments taking part in the trial
Submission date
07/12/2006
Registration date
29/12/2006
Last edited
19/09/2007
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

Plain English summary of protocol

Not provided at time of registration

Contact information

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 information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo 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) studiedSmoking addiction
InterventionIntervention 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 typeOther
Primary outcome measure(s)

Self -reported quit rates validated by Carbon Monoxide (CO) and salivary cotinine

Key secondary outcome measure(s)

1. Changes in smoking behaviour including reduction in number of cigarettes (and change in cotinine levels), and increase in numbers of quit attempts

Completion date01/04/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target sample size at registration120
Key inclusion criteria1. Adult (more than 16 years) smokers of at least ten cigarettes
2. Informed consent
Key exclusion criteria1. Adult (more than 16 years) smokers of less than ten cigarettes
2. Currently receiving smoking cessation therapy elsewhere
Date of first enrolment01/04/2001
Date of final enrolment01/04/2004

Locations

Countries of recruitment

  • United Kingdom
  • Scotland

Study participating centre

Level 8
Glasgow
G2 3JZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

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