A randomised controlled trial to assess whether smoking cessation instruction provided by orthodontists to teenage orthodontic patients is beneficial
| ISRCTN | ISRCTN79526387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79526387 |
| Protocol serial number | Sponsor/protocol No.: 20080D001 |
| Sponsor | University Hospital of South Manchester NHS Foundation Trust (UK) |
| Funders | University Hospital of South Manchester NHS Foundation Trust, Burnley General Hospital, Trafford General Hospital, Tameside General Hospital, Salford Royal Hospital |
- Submission date
- 16/11/2008
- Registration date
- 30/03/2009
- Last edited
- 16/06/2016
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Susi Caldwell
Scientific
Scientific
Department of Orthodontics & Oral Surgery
University Hospital of South Manchester NHS Foundation Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial of smoking cessation instruction in teenage orthodontic patients |
| Study objectives | Null hypothesis: Smoking cessation instruction provided to teenage orthodontic patients will have no impact on quit rates of smoking patients, nor smoking uptake rates of non-smoking patients. |
| Ethics approval(s) | Oldham Research Ethics Committee, 18/02/2009, ref: 09/H1011/1 |
| Health condition(s) or problem(s) studied | Smoking, malocclusion |
| Intervention | The smoking cessation instruction will be verbal from the orthodontist along with pictorial information. The orthodontist will discuss with the patient an information sheet containing facts regarding the effects of smoking on the mouth, face and teeth, as well pictures of such effects. The control group of participants will receive their orthodontic treatment only (no interventions). |
| Intervention type | Other |
| Primary outcome measure(s) |
Smoking status is measured at 6 and 12 months. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Orthodontic patients (both males and females) 11-18 years at start of study 2. About to start or undergoing orthodontic treatment with fixed or removable orthodontic appliances 3. Parental agreement to the child's participation in the study and that the child has full confidentiality regarding their smoking status (if child under 16) |
| Key exclusion criteria | Lack of consent - parental or child |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Orthodontics & Oral Surgery
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/06/2016: No publications found, verifying study status with principal investigator.
