Condition category
Mental and Behavioural Disorders
Date applied
07/12/2006
Date assigned
29/12/2006
Last edited
19/09/2007
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 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

Ethics approval received from the Glasgow Dental Hospital and School Area Dental Ethics Committee in January 2001.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2001

Overall trial end date

01/04/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult (more than 16 years) smokers of at least ten cigarettes
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Adult (more than 16 years) smokers of less than ten cigarettes
2. Currently receiving smoking cessation therapy elsewhere

Recruitment start date

01/04/2001

Recruitment end date

01/04/2004

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
v.binnie@dental.gla.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

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

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=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