Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services
Open accessAbstract
Background: Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods/Design: A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental questionnaires. Discussion: This is a pragmatic trial conducted in general dental practice. It tests a composite caries prevention intervention, which represents an evidence based approach advocated by current guidance from the English Department of Health which is feasible to deliver to all low risk (caries free) children in general dental practice. The trial will provide valuable information to policy makers and clinicians on the costs and effects of caries prevention delivered to young children in general dental practice. Trial registration: EudraCT No: 2009 - 010725 - 39 ISRCTN: ISRCTN36180119 Ethics Reference No: 09/H1008/93:
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Similar challenges have been demonstrated in primary care dental studies with targets being revised, not met and extended.
“Similar challenges have been demonstrated in primary care dental studies with targets being revised, not met and extended [11, 12, 33, 36].”
From Is it feasible to conduct a randomised controlled trial of silver diamine fluoride compared to usual care for the management of caries in children's primary teeth in UK primary dental care? A randomised feasibility study. (2026) · cites this paper as [36]
The Methods/Design sections on sample size and the NIC-PIP time plan give a planned recruitment target of 1,200 children and a planned recruitment period ending in November 2011. They do not report that the target was revised or missed, or that recruitment was extended; searches for those terms found no such passage. Page numbers were not available in our copy. (LLM, conf=0.75)
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- Authors
- Tickle, M., Milsom, K. M., Donaldson, M., Killough, S., O'Neill, C., Crealey, G., Sutton, M., Noble, S., Greer, M., & Worthington, H. V.
- Affiliations
- University of Manchester (GB)
- Health and Social Care Board (GB)
- British Dental Association (GB)
- Royal Victoria Hospital (GB)
- Northern Health and Social Care Trust (GB)
- Corresponding author
- Worthington, Helen V
- Venue
- BMC Oral Health
- Published
- 2011-10-10
- Volume
- 11
- Issue
- 1
- Pages
- 27-27
- ISSN
- 1472-6831 (ISSN-L)
- PMC
- PMC3196725
- OpenAlex
- W1989906539
- Cited by
- 20
- References
- 31
- Citations by year
- 2023: 1 · 2022: 1 · 2021: 1 · 2019: 3 · 2018: 1 · 2017: 3 · 2016: 1 · 2014: 3 · 2013: 1 · 2012: 5
- FWCI
- 3.57
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Oral Health (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ARAN (University of Galway Research Repository) (Ollscoil na Gaillimhe – University of Galway) (acceptedVersion, cc-by-nc-nd)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- ARAN (University of Galway Research Repository) (Ollscoil na Gaillimhe – University of Galway) (submittedVersion, cc-by-nc-nd)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion, cc-by)
- ARAN (University of Galway Research Repository) (Ollscoil na Gaillimhe – University of Galway) (submittedVersion, cc-by-nc)
- Lenus, The Irish Health Repository (Dr Steevens Hospital Library) (submittedVersion)
- Research Repository UCD (University College Dublin) (cc-by-nc)
- Funders
- National Institute for Health and Care Research (08/14/19, HTA/08/14/19)
- Health Technology Assessment Programme (08/14/19)
- Topics
- Health Sciences › Dentistry › Periodontics › Dental Health and Care Utilization
- Health Sciences › Dentistry › Periodontics › Oral microbiology and periodontitis research
- Health Sciences › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
- Keywords
- dental caries prevention, young children, fluoride varnish, fluoride toothpaste, toothbrushes, oral health education, primary dental care, caries incidence, primary teeth, cost-effectiveness, primary tooth extraction, low-risk children
- MeSH terms
- Cariostatic Agents, Child, Preschool, Dental Caries, Fluorides, Topical, Follow-Up Studies, Health Education, Dental, Humans, Northern Ireland, Preventive Dentistry, Primary Health Care, Toothbrushing, Toothpastes, Treatment Outcome, Dental Care for Children
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