Salford Bright Smiles Baby Study
| ISRCTN | ISRCTN67452094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67452094 |
| Protocol serial number | 8483 |
| Sponsor | University of Salford (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) |
- Submission date
- 21/10/2010
- Registration date
- 21/10/2010
- Last edited
- 29/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
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
Ms Rosy Armstrong
Scientific
Scientific
College of Health and Social Care
AD101 Allerton Building
University of Salford
Salford
M6 6PU
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised interventional prevention trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A comparison of community based preventive services to improve child dental health: a single centre randomised interventional prevention trial |
| Study objectives | The primary hypotheses are that: 1. There is no difference in the proportions of children with dental caries at age 3 years between test group 1 (behavioural intervention) and the control group 2. There is no difference in the proportions of children with dental caries at 3 years between test group 2 (fluoride varnishing) and the control group The test interventions will be four semi-annual applications of a fluoride varnish from approximately age 12 months to 30 months, or a ten session group-based behavioural intervention targeting two dental health-related behaviours: establishing twice daily tooth-brushing and a sugar-free bedtime routine, compared to a new standard dental service offered to families with babies aged 9 - 12 months. There will be no specific criteria for excluding any child in the trial except with reference to the provision of fluoride varnish which is contraindicated with previous hospitalisation because of hypersensitivity reactions including asthma. |
| Ethics approval(s) | North West 8 REC Greater Manchester East, 26/03/2010, ref: 10/H1013/8 |
| Health condition(s) or problem(s) studied | Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases |
| Intervention | 1. A group-based behavioural intervention targeting two dental health related behaviours: Establishing twice daily tooth-brushing and a sugar-free bedtime routine, The behavioural interventions will be delivered as group sessions of 8 - 10 parents facilitated by a healthcare professional and an 'expert parent'. The intervention will be delivered in blocks of two or three weekly sessions over 10 to 12 sessions as the child's age increases from 12 to 30 months. 2. A clinical intervention of semi annual applications of fluoride varnish (up to 0.4 ml of 0.9% difluorosilane in a polyurethane varnish base). Four doses of topically applied fluoride varnish will be delivered to the deciduous teeth of infants commencing at a minimum age of 12 months and repeated at approximately 18, 24 and 30 months. Duration of both interventions: 18 months Follow up length: 24 months Study entry: single randomisation only |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Improvement in dental health, measured by the standard dental index (d1mft) number of decayed, extracted and filled teeth. Measured at age 2 years and age 3 years (12 and 24 months from enrolment respectively). |
| Key secondary outcome measure(s) |
Enhancement of parental efficacy to undertake two key dental health-related behaviours, measured twice daily at baseline, age 2 and age 3 (enrolment,12 and 24 months). |
| Completion date | 30/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 732 |
| Key inclusion criteria | 1. Parents or principal carers of a child between 8 and 12 months of age at recruitment 2. Residing in the City of Salford 3. Able to read and understand the study literature with/out a translator/interpreter and provide written informed consent |
| Key exclusion criteria | There will be no specific criteria for excluding any child in the trial except with reference to the provision of fluoride varnish which is contra-indicated with previous hospitalisation because of hypersensitivity reactions including asthma. |
| Date of first enrolment | 30/04/2010 |
| Date of final enrolment | 30/10/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Salford
Salford
M6 6PU
United Kingdom
M6 6PU
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
29/03/2018: No publications found, verifying study status with principal investigator.
05/02/2016: No publications found, study status unverified.
