Condition category
Oral Health
Date applied
27/04/2017
Date assigned
10/05/2017
Last edited
11/09/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 11/09/2018:
Background and study aims
Tooth decay is very common, affecting nearly half of young people aged 12-15 years in deprived areas. Regular tooth brushing with fluoride toothpaste can prevent it. In New Zealand a study found that sending unemployed young adults a text message on their mobile phone every week increased how often they brushed their teeth. The aim of this study is to find out whether an intervention which involves a school lesson about dental health followed by a series of text messages reduces tooth decay, increases how often (and how well) young people brush their teeth, and is cost effective.

Who can participate?
Young people aged 11-13 years old (Year 7 and Year 8, 1st Year and 2nd Year in Scotland) in participating schools in deprived areas in England (South Yorkshire and West Yorkshire), Scotland and Wales (South Wales).

What does the study involve?
A pilot study is being conducted in 10 schools with approximately 1200 young people to check whether it is possible to run the main study and to find the best ways of doing so. The main study would involve a total of 48 (updated to 38 on 05/09/2017) schools and 5760 (updated to approximately 4560 on 05/09/2017) young people. In each school one year group is randomly allocated to receive the intervention and another year group does not receive the intervention. Over the following 3 years dentists go into the schools to conduct dental examinations and young people and parents/carers are asked to fill out questionnaires to collect information about tooth decay, how often they brush their teeth and how much tooth decay affects their lives. This shows whether there is a difference between those who receive the intervention and those who do not. The researchers also find out how well the intervention is working from school staff, young people and parents/carers.

What are the possible benefits and risks of participating?
Although taking part may not directly benefit schools and young people/parents/carers, it is hoped that the results will help other schools and young people in the future to have healthy teeth. Schools are offered £1000 to cover the extra administrative tasks associated with taking part in this study. All young people who agree to take part are entered into a prize draw with the chance of winning £100 in vouchers. Furthermore, all young people who complete the first questionnaire and dental assessment given a £10 shopping voucher to say thank you for their time. Young people are also given a £5 shopping voucher after they have completed the final questionnaire and dental assessment to say thank you. Finally, all parents/carers who complete the final parents/carer questionnaire are entered into a prize draw with the change of winning £100 in vouches There are no known risks from taking part in the study. The burden of participation for young people/parents/carers is minimal, limited to the time taken to complete questionnaires and be seen for dental assessments (young people only). It is hoped that young people will enjoy taking part and benefit from engaging with the study.

Where is the study run from?
1. Tayside Medical Science Centre & University of Dundee (UK)
2. University of Sheffield (UK)
3. University of Leeds (UK)
4. Cardiff University & Cardiff & Vale UHB (UK)

When is the study starting and how long is it expected to run for?
January 2017 to October 2021

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

Who is the main contact?
1. Dr Zoe Marshman (scientific)
Z.Marshman@sheffield.ac.uk
2. Prof. Nicola Innes (scientific)
n.p.innes@dundee.ac.uk
3. Mrs Hannah Ainsworth (public)
hannah.ainsworth@york.ac.uk


Previous plain English summary:
Background and study aims
Tooth decay is very common, affecting nearly half of young people aged 12-15 years in deprived areas. Regular tooth brushing with fluoride toothpaste can prevent it. In New Zealand a study found that sending unemployed young adults a text message on their mobile phone every week increased how often they brushed their teeth. The aim of this study is to find out whether an intervention which involves a school lesson about dental health followed by a series of text messages reduces tooth decay, increases how often (and how well) young people brush their teeth, and is cost effective.

Who can participate?
Young people aged 11-13 years old (Year 7 and Year 8, 1st Year and 2nd Year in Scotland) in participating schools in deprived areas in England (South Yorkshire and West Yorkshire), Scotland and Wales (South Wales).

What does the study involve?
A pilot study is being conducted in 10 schools with approximately 1200 young people to check whether it is possible to run the main study and to find the best ways of doing so. During the pilot 1073 young people will be randomised into the trial. The main trial aims to recruit a further 32 schools and 3967 young people. Including the pilot, in total the trial aims to recruit 42 schools and 5040 young people in total. In each school one year group is randomly allocated to receive the intervention and another year group does not receive the intervention. Over the following 3 years dentists go into the schools to conduct dental examinations and young people and parents/carers are asked to fill out questionnaires to collect information about tooth decay, how often they brush their teeth and how much tooth decay affects their lives. This shows whether there is a difference between those who receive the intervention and those who do not. The researchers also find out how well the intervention is working from school staff, young people and parents/carers.

What are the possible benefits and risks of participating?
Although taking part may not directly benefit schools and young people/parents/carers, it is hoped that the results will help other schools and young people in the future to have healthy teeth. All young people who complete the first questionnaire and dental assessment given a £10 shopping voucher to say thank you for their time. Young people are also given a £5 shopping voucher after they have completed the final questionnaire and dental assessment to say thank you. Finally, all parents/carers who complete the final parents/carer questionnaire are entered into an annual prize draw with the change of winning £300 in vouchers There are no known risks from taking part in the study. The burden of participation for young people/parents/carers is minimal, limited to the time taken to complete questionnaires and be seen for dental assessments (young people only). It is hoped that young people will enjoy taking part and benefit from engaging with the study.

Where is the study run from?
1. Tayside Medical Science Centre & University of Dundee (UK)
2. University of Sheffield (UK)
3. University of Leeds (UK)
4. Cardiff University & Cardiff & Vale UHB (UK)

When is the study starting and how long is it expected to run for?
January 2017 to October 2021

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

Who is the main contact?
1. Dr Zoe Marshman (scientific)
Z.Marshman@sheffield.ac.uk
2. Prof. Nicola Innes (scientific)
n.p.innes@dundee.ac.uk
3. Mrs Hannah Ainsworth (public)
hannah.ainsworth@york.ac.uk

Trial website

bit.ly/bright-trial

Contact information

Type

Scientific

Primary contact

Prof Zoe Marshman

ORCID ID

http://orcid.org/0000-0003-0943-9637

Contact details

School of Clinical Dentistry
The University of Sheffield
Claremont Crescent
Sheffield
S10 2TA
United Kingdom
+44 (0)114 215 9398
Z.Marshman@sheffield.ac.uk

Type

Scientific

Additional contact

Prof Nicola Innes

ORCID ID

http://orcid.org/0000-0002-9984-0012

Contact details

School of Dentistry
University of Dundee
Dundee Dental Hospital & School
Park Place
Dundee
DD1 4HN
United Kingdom
+44 (0)1382381 631
n.p.innes@dundee.ac.uk

Type

Public

Additional contact

Mrs Hannah Ainsworth

ORCID ID

http://orcid.org/0000-0001-8461-2183

Contact details

York Trials Unit
Department of Health Sciences
ARRC Building
University of York
York
YO10 5DD
United Kingdom
+44 (0)1904 328158
hannah.ainsworth@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 15/166/08; Protocol Version 2.0

Study information

Scientific title

BRIGHT Trial: Brushing RemInder 4 Good oral HealTh: the clinical and cost-effectiveness of a Short Messaging Service behaviour change programme to improve the oral health of young people living in deprived areas

Acronym

BRIGHT

Study hypothesis

Does a Short Messaging Service (SMS) behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas?

Ethics approval

East of Scotland Research Ethics Service REC 1, 14/08/2017, ref: 17/ES/0096

Study design

Multi-centre school-based assessor-blinded two-arm cluster-randomised controlled trial with an internal pilot trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Available on the BRIGHT website: bit.ly/bright-trial

Condition

Dental health

Intervention

Current interventions as of 11/09/2018:
The BRIGHT project will use a cluster randomised controlled trial (RCT) to test whether an intervention which involves a short classroom-based session embedded in the curriculum about dental health followed by a series of text messages reduces tooth decay, increases how often (and how well) young people brush their teeth and how cost effective it is.
The trial will run in schools in deprived areas in England, Scotland and Wales. First, an internal pilot study will be conducted, to check whether it is possible to run the main trial and the best ways of doing so. The pilot will ruin in 10 schools, with approximately 1200 young people. The feasibility of allocating within schools will be tested by randomising these schools 1:1 into one of two regimes:
1. Pupils of 11-12 years (Year 7, 1st Year in Scotland) will receive the intervention and pupils of 12-13 years (Year 8, 2nd Year in Scotland) will act as the control group
2. Pupils of 12-13 years (Year 8, 2nd Year in Scotland) will receive the intervention and pupils of 11-12 years (Year 7, 1st Year in Scotland) will act as the control group
An allocation sequence, stratified by school using blocks of size two, will be generated by an independent YTU statistician. If the pilot study suggests this method is not feasible and there proves to be excessive contamination between school years, then in the main trial, the unit of randomisation will switch to the school. Schools will be randomised 1:1 to receive the intervention or control. Randomisation by school will be undertaken by an independent YTUs statistician using minimisation.
If the pilot shows that the main trial is possible, the trial will recruit 42 schools (10 in the pilot and 32 in the main trial), and 5040 young people aged between 11-13 years of age. Please note that the pilot has been completed, and the main trial is now underway. The intervention will be allocated within each participating school 1:1 to one of two regimes:
1. Pupils of 11-12 years (Year 7, 1st Year in Scotland) will receive the intervention and pupils of 12-13 years (Year 8, 2nd Year in Scotland) will act as the control group
2. Pupils of 12-13 years (Year 8, 2nd Year in Scotland) will receive the intervention and pupils of 11-12 years (Year 7, 1st Year in Scotland) will act as the control group
Again, an allocation sequence, stratified by school using blocks of size two, will be generated by an independent YTU statistician.
Outcome information will be collected for 3 years; dentists will go into schools to conduct dental examinations and young people and parents/carers will be asked to fill out questionnaires to collect information about tooth decay, how often they brush their teeth and how much tooth decay affects their lives. This will allow the trialists to investigate whether there is a difference between those who receive the intervention and those who do not. The trialists will also find out how well the intervention is working from school staff, young people and parents/carers.

Current interventions as of 05/09/2017:
The BRIGHT project will use a cluster randomised controlled trial (RCT) to test whether an intervention which involves a short classroom-based session embedded in the curriculum about dental health followed by a series of text messages reduces tooth decay, increases how often (and how well) young people brush their teeth and how cost effective it is.

The trial will run in schools in deprived areas in England, Scotland and Wales. A pilot trial will be conducted to check whether it is possible to run the main trial and the best ways of doing so. The pilot will run in 10 schools with approximately 1200 young people. If the pilot shows the main trial is possible we will involve a total of 48 schools and approximately 5760 young people.

In the pilot trial, the feasibility of allocating within schools will be tested by randomising schools 1:1 to one of two regimes:
1. Pupils of 11-12 years (Year 7, 1st Year in Scotland) will receive the intervention and pupils of 12-13 years (Year 8, 2nd Year in Scotland) will act as the control group
2. Pupils of 12-13 years (Year 8, 2nd Year in Scotland) will receive the intervention and pupils of 11-12 years (Year 7, 1st Year in Scotland) will act as the control group
An allocation sequence, stratified by school using blocks of size two, will be generated by an independent YTU statistician. If the pilot study suggests this method is not feasible and there proves to be excessive contamination between school years, then in the main trial, the unit of randomisation will switch to the school. Schools will be randomised 1:1 to receive the intervention or control. Randomisation by school will be undertaken by an independent YTU statistician using minimisation.

Outcome information will be collected for 3 years; dentists will go into schools to conduct dental examinations and young people and parents/carers will be asked to fill out questionnaires to collect information about tooth decay, how often they brush their teeth and how much tooth decay affects their lives. This will allow the trialists to investigate whether there is a difference between those who receive the intervention and those who do not. The trialists will also find out how well the intervention is working from school staff, young people and parents/carers.

Previous interventions:
The BRIGHT project will use a cluster randomised controlled trial (RCT) to test whether an intervention which involves a short classroom-based session embedded in the curriculum about dental health followed by a series of text messages reduces tooth decay, increases how often (and how well) young people brush their teeth and how cost effective it is.

The trial will run in schools in deprived areas in England, Scotland and Wales. A pilot trial will be conducted to check whether it is possible to run the main trial and the best ways of doing so. The pilot will run in 10 schools with 1200 young people. If the pilot shows the main trial is possible we will involve a total of 48 schools and 5760 young people.

In the pilot trial, the feasibility of allocating within schools will be tested by randomising schools 1:1 to one of two regimes:
1. Pupils of 11-12 years (Year 7, 1st Year on Scotland) will receive the intervention and pupils of 12-13 years (Year 8) will act as the control group
2. Pupils of 12-13 years (Year 8) will receive the intervention and pupils of 11-12 years (Year 7, 2nd Year in Scotland) will act as the control group
An allocation sequence, stratified by school using blocks of size two, will be generated by an independent YTU statistician. If the pilot study suggests this method is not feasible and there proves to be excessive contamination between school years, then in the main trial, the unit of randomisation will switch to the school. Schools will be randomised 1:1 to receive the intervention or control. Randomisation by school will be undertaken by an independent YTUs statistician using minimisation.

Outcome information will be collected for 3 years; dentists will go into schools to conduct dental examinations and young people and parents/carers will be asked to fill out questionnaires to collect information about tooth decay, how often they brush their teeth and how much tooth decay affects their lives. This will allow the trialists to investigate whether there is a difference between those who receive the intervention and those who do not. The trialists will also find out how well the intervention is working from school staff, young people and parents/carers.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Incidence of carious lesions in permanent teeth, measured using decayed, missing, and filled teeth (DMFT) index, where decay is measured as caries into dentine - International Caries Detection and Assessment System [ICDAS] levels 4-6, at 3 years follow up

Secondary outcome measures

1. Frequency of twice-daily tooth brushing, measured using self-report: 0, at time of CBS (pilot only), 3 months (pilot only), 6 months, 1, 2 and 3 years, confirmed by clinically assessed plaque levels and gingival bleeding scores recorded at 0, 2 and 3 years
2. Incidence of carious lesions in permanent teeth at 2 years, measured using DMFT where decay is measured as caries into dentine - International Caries Detection and Assessment System [ICDAS] levels 4-6, at 2 years follow up
3. Child health-related quality of life and oral health-related quality of life, measured using Child Health Utility-9D and CARIES-QC at 0, 1, 2, 3 years
4. Oral health behaviours, measured using self-report: 0, at time of CBS (pilot only), 3 months (pilot only), 6 months, 1, 2, 3 years
5. Cost effectiveness, measured using parent self-report resource use at 0, 1, 2, 3 years
6. School attendance, measured using school records at 0, 1, 2, 3 years
7. Intervention compliance, measured using school self report at the time of classroom based session and SMS records at the end of intervention period (TBC)

Overall trial start date

01/01/2017

Overall trial end date

01/10/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 05/09/2017:
1. Attend a participating school
2. Aged 11-12 years (in Year 7 in England/Wales and 1st Year in Scotland) or 12-13 years (in Year 8 in England/Wales and 2nd Year in Scotland)

Previous inclusion criteria:
1. Attend a participating school
2. Aged 11-12 years (in Year 7, England/Wales and S1 year in Scotland) or 12-13 years (in Year 8 in England/Wales and S2 Year in Scotland)

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

42 secondary schools: 120 pupils per school. Total of 5040 young people

Participant exclusion criteria

No functioning mobile telephone

Recruitment start date

01/07/2017

Recruitment end date

31/03/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tayside Medical Science Centre & University of Dundee
George Pirie Way
Dundee
DD1 9SY
United Kingdom

Trial participating centre

University of Sheffield
School of Clinical Denistry Claremont Cresent
Sheffield
S10 3PE
United Kingdom

Trial participating centre

University of Leeds
Leeds Dental School
Leeds
LS2 9JT
United Kingdom

Trial participating centre

Cardiff University & Cardiff & Vale UHB
Cardiff University Dental School College of Biomedical and Life Sciences
Cardiff
CF12 4XY
United Kingdom

Sponsor information

Organisation

University of Dundee

Sponsor details

TASC
Ninewells Hospital & Medical School
Research Development Office
Residency Block
Level 3
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383890
c.forde@dundee.ac.uk

Sponsor type

University/education

Website

Organisation

Tayside Medical Science Centre

Sponsor details

TASC
Ninewells Hospital & Medical School
Research Development Office
Residency Block
Level 3
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383890
c.forde@dundee.ac.uk

Sponsor type

Hospital/treatment centre

Website

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

The results will be published in an HTA monograph and high impact, peer reviewed dental journals and in education academic journals and newsletters. The intent to publish date is October 2022. The results will be presented at the International Association for Dental Research, British Association for Study of Community Dentistry and Secondary Education conference. The findings will also be disseminated to the wider public health community via the Public Health England annual conference and secondary school education communities.

IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/09/2018: The following changes have been made to the trial record: 1. The primary contact title has been changed from "Dr" to "Prof" and the telephone number has been corrected 2. The protocol/serial number was changed from "HTA 15/166/08; Protocol Version 2.0" to "HTA 15/166/08; Protocol Version 5.0" 3. The interventions have been updated 4. The trial website has been added 5. The patient information sheet was changed from "Not available in web format, please use the contact details to request a patient information sheet" to "Available on the BRIGHT website: bit.ly/bright-trial" 6. The target number of participants has been changed from "48 secondary schools: 120 pupils per school. Total of 5760 young people" to "42 secondary schools: 120 pupils per school. Total of 5040 young people" 7. The recruitment end date has been changed from 01/07/2018 to 31/03/2019 8. The plain English summary has been updated 05/09/2017: Ethics approval has been added. ORCID has been added. Interventions have been updated. Plain English summary has been updated. Dr Marshman's email has been updated from +44 (0)114 2717896 to +44 (0)114 215 9319.