Salford Bright Smiles Baby Study

ISRCTN	ISRCTN67452094
DOI	https://doi.org/10.1186/ISRCTN67452094
Secondary identifying numbers	8483

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

College of Health and Social Care
AD101 Allerton Building
University of Salford
Salford
M6 6PU
United Kingdom

Study information

Study design	Single-centre randomised interventional prevention trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a 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	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).
Secondary outcome measures	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).
Overall study start date	30/04/2010
Completion date	30/10/2013

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	Planned sample size: 732; UK sample size: 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

England
United Kingdom

Study participating centre

University of Salford

Salford
M6 6PU
United Kingdom

Sponsor information

University of Salford (UK)
University/education

c/o Tony Warne
Professor in Mental Health Care
Associate Dean (Research)
Head of School
School of Nursing & Midwifery
Mary Seacole Building
Salford
M6 6PU
England
United Kingdom

Phone	+44 (0)161 295 2779
Email	a.r.warne@salford.ac.uk
Website	http://www.salford.ac.uk
"ROR"	https://ror.org/01tmqtf75

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

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

Editorial Notes

29/03/2018: No publications found, verifying study status with principal investigator.
05/02/2016: No publications found, study status unverified.