NIC-PIPNIC-PIP logo

Trial Acronym NIC-PIP
Clinical Area Dentistry
Description A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.
Status Closed
RECRUITMENT
Date Opened to Recruitment April 2011
Target Recruitment 1200
Recruitment to date 1248 (Completed)
TRIAL DESIGN
Trial Design Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) is an individually randomised, two-compartment, parallel group phase IV pragmatic trial. Children will be randomised 1:1 into two groups.
Study Aim To measure the costs and effects of a ‘preventive package’ in keeping young children who regularly attend primary care service free of dental caries, compared with standard health education alone. The preventive package comprised of:

  • Fluoride varnish containing 22,600 ppm fluoride applied twice a year
  • A toothbrush provided twice a year
  • Standardised, evidence based, dental health education provided twice a year.

 

Objective 1: To compare over a 3 year period the effectiveness of 22.600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste, toothbrush and standardized health education, provided twice a year, as a preventive package, with standardised health education alone provided twice a year in:

  • Preventing the conversion of children from caries-free to caries-active states in the primary dentition
  • Reducing the number of carious surfaces (caries into dentine) in the primary dentition in children who convert from caries free to caries active states
  • Preventing episodes of pain and extraction of primary teeth in 2 and 3 year old children who are caries free at baseline and who attend primary care dentalservices
Objective 2: To compare over a 3 year period the costs of dental care in a group receiving 22,600 ppm fluoride vcarnish, 1,450 ppm fluoride toothpaste, toothbrush and standardised health education, provided twice a year as a preventive package with a group receiving standardised heatlh education alone provided twice a year, in 2 and 3 year old children who are caries free at baseline and who attend primary care dental services.
CHIEF INVESTIGATOR (CI)
Chief Investigator Professor Martin Tickle
SPONSOR(s) & FUNDER(s)
Sponsor Belfast Health and Social Care Trust and University of Manchester
Funder NIHR_Health Technology Assessment (HTA)