Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8483
Study information
Scientific title
A comparison of community based preventive services to improve child dental health: a single centre randomised interventional prevention trial
Acronym
Study hypothesis
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
North West 8 REC Greater Manchester East, 26/03/2010, ref: 10/H1013/8
Study design
Single-centre randomised interventional prevention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
30/04/2010
Overall trial end date
30/10/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
Planned sample size: 732; UK sample size: 732
Participant 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.
Recruitment start date
30/04/2010
Recruitment end date
30/10/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Salford
Salford
M6 6PU
United Kingdom
Sponsor information
Organisation
University of Salford (UK)
Sponsor details
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
United Kingdom
+44 (0)161 295 2779
a.r.warne@salford.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK)
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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