Condition category
Oral Health
Date applied
14/08/2009
Date assigned
19/08/2009
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tooth decay in the primary (milk) teeth is the most common disease in childhood. Once children develop tooth decay they very commonly suffer toothache and then often need to have their teeth extracted, all of which has a big effect on young children and their families. Tooth decay is preventable but recent research shows that preventative care provided by family dentists working in the NHS is unreliable and ineffective. This study will evaluate the effects and costs of a simple ‘prevention package’ provided by family dentists to children aged 2-4 who are free of decay at the beginning of the study.

Who can participate?
Children aged 2 to 4 years attending selected General Dental Service practices/Community Dental Service clinics.

What does the study involve?
Once parents have agreed to let their children take part in the study, children will randomly be allocated to one of two groups. One group will get the prevention package twice a year over a 3-year period. The prevention package we will test consists of three things: fluoride varnish painted on the teeth by the dentist, family-strength fluoride toothpaste and simple advice on how to prevent tooth decay. The other group will only receive the simple advice on how to prevent tooth decay. All children will attend their dentist at 6 monthly intervals. The study will compare the numbers of children who develop tooth decay in each group over a 3-year period. The children will receive a standardised dental examination at the start and end of the study by trained and calibrated dentists who are unconnected to the practices. The number of children who have toothache or have teeth extracted will also be counted and compared. The costs to the NHS and to parents of providing the prevention package will be measured and the costs of providing dental treatments such as fillings and extractions will be assessed in both groups.

What are the possible benefits and risks of participating?
The varnish used in the study has been widely used across the world for many years and any side-effects to the varnish are extremely unlikely to occur and would be very mild if they do. In addition to fluoride, the varnish contains ethanol and a natural resin called colophony, which is found in sticking plasters. In highly exceptional circumstances, use of colophony has resulted in allergic reactions and for this reason we are excluding all children who have been hospitalised due to severe asthma or other allergic conditions. Another possible side effect is dental fluorosis which may occur and which affects adult teeth. In its mildest form dental fluorosis appears as fine white lines or flecking on the enamel surface of the teeth, which can often only be detected by a dental expert. This is unlikely because evidence-based advice will be given to parents on use of fluoride toothpaste and the fluoride varnish is professionally applied according to guidance.

Where is the study run from?
University of Manchester (UK)

When is the study starting and how long is it expected to run for?
October 2009 to September 2015

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof. Martin Tickle
martin.tickle@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Tickle

ORCID ID

http://orcid.org/0000-0001-5348-5441

Contact details

School of Dentistry
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 6610
martin.tickle@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 08/14/19

Study information

Scientific title

A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

Acronym

NIC-PIP

Study hypothesis

Whether a preventive package supplied to young children regularly attending general dental practice will be effective in keeping them free from dental caries.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081419
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0004/52366/PRO-08-14-19.pdf

Ethics approval

Central Manchester Research Ethics Committee, 08/07/2009, ref: 09/H1008/93

Study design

Individually randomised two-compartment parallel-group phase IV pragmatic 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 patient information sheet

Condition

Dental caries

Intervention

Test Group:
The application, by a dentist, twice a year, at approximately 6-monthly intervals and for 3 years, of 22600 ppm fluoride varnish and the supply, twice a year, of 1450 ppm toothpaste plus toothbrush and standardised health education delivered by the dentist or hygienist.

Control Group:
Standardised health education delivered by the dentist or hygienist.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

The conversion of caries free children to caries active (caries into dentine) children, measured at baseline and at 36 months.

Secondary outcome measures

Assessed by parental questionnaires and site-based clinical data collection forms at 6-monthly intervals from 6 months through to 36 months:
1. The number of carious surfaces (caries into dentine in primary teeth) that develop in children who convert from caries free to caries active
2. The effect on direct and indirect costs

Overall trial start date

01/10/2009

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 2 to 4 years, either sex
2. Attending selected General Dental Service practices/Community Dental Service clinics
3. Parent or legal guardian signs a Consent Form

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Children with caries into dentine
2. A past history of fillings or extractions due to caries
3. Children with fissure sealants on primary molar teeth
4. Children with history of severe allergic reactions requiring hospitalisation
5. Children already participating in any other clinical study at recruitment

Recruitment start date

13/04/2011

Recruitment end date

29/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9PL
United Kingdom

Trial participating centre

22 dental practices in Northern Ireland
-
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 8795
research-governance@manchester.ac.uk

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

King Edward Building
Royal Victoria Hospital Site
Grosvenor Road
Belfast
BT12 6BA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.belfasttrust.hscni.net/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

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

14/10/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21985746
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27685609

Publication citations

  1. Protocol

    Tickle M, Milsom KM, Donaldson M, Killough S, O'Neill C, Crealey G, Sutton M, Noble S, Greer M, Worthington HV, 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., BMC Oral Health, 2011, 11, 27, doi: 10.1186/1472-6831-11-27.

Additional files

Editorial Notes

30/09/2016: Publication reference added. 14/07/2015: the overall trial end date was changed from 31/01/2014 to 30/09/2015.