Condition category
Digestive System
Date applied
30/11/2015
Date assigned
11/01/2016
Last edited
15/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Tooth decay in children is a serious health problem, causing pain, poor sleep and missed time from school. At worst, tooth decay means that children have several or all of their time extracted, typically under general anaesthetic, where they are unconscious during the operation. Children and their families may have to wait for this operation and feel worried about it. This can be prevented with good oral health care. Beyond dental care, child welfare and oral health are both public health issues. The aim of this study is to test the benefits of supplying free toothpaste, brushes and guidance information (by post) to all people in a family.

Who can participate?
All children 3-10 years or under, in at risk families within the North West UK, specifically from hospitals at Bolton, Stockport, Manchester, Salford and Trafford. Families are identified as 'at risk' when a child in the family has had extractions under anaesthetic.

What does the study involve?
Families are randomly allocated to either receive free toothpaste, brushes and guidance information (with 3 monthly supplies), or to receive standard oral health advice, to see whether this reduces the need for further extractions under anaesthetic. Samples of families who received the brushing materials are interviewed to help us understand their experiences and factors which could help with this scheme in the future. A small number who receive the packs also receive text message reminders and are interviewed by a researcher in their home. This is done with one group near the beginning and another group towards the end of the study.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
1. Central Manchester Foundation Trust (UK)
2. Salford Royal Foundation Trust (UK)
3. Stepping Hill Hospital (UK)
4. Royal Bolton Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2015 to February 2018

Who is funding the study?
Colgate-Palmolive Company (USA)

Who is the main contact?
Charlotte Wilson
charlotte.wilson-4@postgrad.manchester.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Charlotte Wilson

ORCID ID

Contact details

Dental Health Unit
Williams House
Manchester Science Park
Lloyd St North
Manchester
M15 6SE
United Kingdom
+44 (0)161 232 4711
charlotte.wilson-4@postgrad.manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial of a targeted distributed toothpaste and toothbrushing programme to reduce paediatric general anaesthetic operations for dental procedures in young children from at-risk families

Acronym

DTBP 'Tiger Teeth'

Study hypothesis

A regular postal distribution of toothpaste and toothbrushes to high-risk families over 24 months will reduce child referrals for Dental General Anaesthetic operations (for extractions as a result of caries) and be cost effective.

Ethics approval

Northwest Preston REC, 09/02/2016, ref: 16/NW/0057

Study design

Single-blind parallel randomised controlled (clustered) clinical trial combined with qualitative research

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tooth decay/dental caries in young children

Intervention

The DTBP intervention is a simple, structured and potentially cost effective programme for young children within high risk families. It aims to supply parents with the materials to improve oral health routines in line with Public Health England’s evidence based tool-kit for prevention (2014). This includes 1450ppm (50 ml) toothpaste free of charge for all families and an information leaflet, with regular (3 monthly) prompts and supplies. There is substantial evidence that the Sugar Acid Neutraliser product is effective in preventing caries. In delivering the programme over 24 months it aims to promote longer term behavioural change i.e regular, twice daily brushing with a pea size amount of paste (smear for the youngest children <5 years), combined with simple public health messages. This begins the habituation process associated with effective adult oral health behaviour. Postal administration has been chosen in order to maximise the convenience for families with young children. ‘Tiger Teeth’ imagery and packaging is also used to appeal to children and improve uptake of the programme. The control group will have access to treatment as usual and standard public health advice. In recognition of their participation they will receive a free dental health care pack at the end of the trial.

Text messaging is also convenient and widely used; with recent evidence to suggest beneficial and acceptable use for parents in children’s dental health care. As such, this role of text message prompts along with the standard intervention will be tested in two small samples of families.

Added 09/02/2016:
The intervention will include a simple timer to the initial toothpaste and toothbrush mailing pack to provide a reminder and aid that toothbrushing should be undertaken for 2 minutes.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Referral of any child age 3-10 (within eligible ‘at risk’ families) for routine dental extraction under general anaesthesia (DGA) as a result of caries in the follow up period of 24 months and within 6 to 24 months of the intervention.

Secondary outcome measures

Intervention cost effectiveness will be determined by a simple cost benefit analysis i.e. the cost of the intervention against benefits to the NHS in preventing referrals for DGA extractions.

Overall trial start date

01/02/2015

Overall trial end date

01/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Families with young children aged 3-10 years at time of recruitment (including siblings of children who have recently attended for a DGA)
2. Families attending clinic for a routine extraction of one or more of their children’s teeth under general anaesthetic, with cause attributed to dental caries
3. Families with English literacy sufficient to provide informed consent and understand brief DTBP health prevention information sheet

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

Trial only: 834 families; Qualitative: 32 families; 16 professionals

Participant exclusion criteria

1. Families attending clinic for a routine extraction of one or more of their children’s teeth under general anaesthetic, with complex causality (other than dental caries alone)
2. Families with definite plans to move out of the area within 2 years (Greater Manchester)
3. Families highlighted as raising safeguarding issues on clinic notes or by clinical staff
4. Children who are in receipt of a prescribed high fluoride toothpaste such as Duraphat 2800, Duraphat 5000 or another fluoride product

Recruitment start date

10/02/2015

Recruitment end date

10/09/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central Manchester Foundation Trust
M13 9PL
United Kingdom

Trial participating centre

Salford Royal Foundation Trust
M6 8HD
United Kingdom

Trial participating centre

Stepping Hill Hosptial
SK2 7JE
United Kingdom

Trial participating centre

Royal Bolton Hospital
BL4 0HX
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Colgate-Palmolive Company

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/02/2016: Added ethics approval details 09/02/2016: Added additional information to intervention field