Evaluation of a school-based brushing programme using a smart toothbrush
| ISRCTN | ISRCTN77803149 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77803149 |
| IRAS number | 326880 |
| Secondary identifying numbers | 2023-15413-27815, IRAS 326880, CPMS 55635 |
- Submission date
- 10/08/2023
- Registration date
- 28/12/2023
- Last edited
- 13/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Dental caries (tooth cavities) in children remain an important public health issue, especially in areas of North West England and Greater Manchester. Dental caries are a preventable disease through adequate and frequent oral hygiene practices. School brushing programmes supporting optimal oral hygiene practices face barriers to implementation. Connected technologies and toothbrushes can overcome some of those barriers and support children to achieve optimal oral hygiene.
The main aim of this study is to explore the acceptability of a smart, connected brush with primary school age children living in underserved areas of Greater Manchester.
Who can participate?
Children aged 8-11 and their caregivers in primary schools across Greater Manchester
What does the study involve?
Teachers will provide students with the brushes and show them how to use them (after teachers receive training from the research team). Parents in the text message intervention group will be signed up to receive text messages too. Parents will complete a series of baseline measurements as outlined in our data collection document. Children will start using the product after they complete the baseline measurements for a 3-month period. Children will use the brush with parental support each morning and night. Teachers will receive a weekly dashboard showing how each class/school is doing to encourage children to brush more if necessary. At the end of the study, teachers and parents will receive a brief feedback form.
What are the possible benefits and risks of participating?
There are very few risks of taking part in the study. The brush is approved and used across the US with very little risk posed to children taking part. The app complies with all relevant data protection and safety laws. All data will be anonymised and safely stored to avoid any issues during and after the study.
Participants will be helping the researchers to better understand how to support children to create better oral hygiene routines and the role schools can play in this process. Children will be allowed to keep the brush at the end of the study and each participating family will receive a voucher for their participation in the study.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
September 2022 to August 2023
Who is funding the study?
Colgate-Palmolive (USA)
Who is the main contact?
1. Dr Michaela Goodwin, michaela.goodwin@manchester.ac.uk
2. Dr George Kitsaras, georgios.kitsaras@manchester.ac.uk
Contact information
Principal Investigator
Dental Health Unit
Williams House
Manchester Science Park
Manchester
M15 6SE
United Kingdom
 ORCID ID |
0000-0002-1631-1730 |
|---|---|
| Phone | +44 (0)161 226 1211 |
| georgios.kitsaras@manchester.ac.uk |
Principal Investigator
Dental Health Unit
Williams House
Manchester Science Park
Manchester
M15 6SE
United Kingdom
| ORCID ID |
0000-0002-0375-3118 |
|---|---|
| Phone | +44 (0)161 226 1211 |
| michaela.goodwin@manchester.ac.uk |
Study information
| Study design | Feasibility cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Quality of life |
| Participant information sheet | Not applicable in web format, please use contact details to request a participant information sheet |
| Scientific title | Exploring the feasibility of a school-based connected-brushing programme and its acceptability to teachers, children and caregivers |
| Study acronym | Leapfrog |
| Study hypothesis | Feasibility study to explore the acceptability of a smart, electric brush in primary school age children in underserved areas of Greater Manchester |
| Ethics approval(s) |
Approved 05/12/2022, University of Manchester Proportionate UREC (Oxford Road, Manchester, M13 9PL, United Kingdom; +44 (0)1613066000; propUREC@manchester.ac.uk), ref: 2023-15413-27815 |
| Condition | Improving oral hygiene practices in primary school children in underserved areas of Manchester |
| Intervention | All participating children will receive a smart, electric toothbrush to use each day at home (morning and bedtime). The smart, electric brush captures information on coverage, duration and frequency of brushing commuting these data to children while they brush via an accompanying app. Apart from the brush, teachers will have access to a brief, class-level dashboard where they can see how their class is doing (in comparison with other classes) and set challenges for the children to help them achieve better goals (or maintain good practices if they do well). Finally, a subset of children will be assigned text message support (delivered to their parents' mobile phones). Text messages will contain messages directed at parents and children to emphasize key messages and to motivate them to continue using the brush. All intervention elements will be delivered for 3 months (follow-up period). Brushes will be used at home directly by children with parental supervision. Teachers will receive access to the weekly dashboard on Monday each week. On school closures (Easter, Summer break, half-term etc) no dashboard will be provided. In the text message subgroup, parents will receive messages in a tapered approach with more text messages at the start and less towards the end of the study. In total, each parent will receive nine text messages over the course of the study. Allocation on treatment arms will be at the school level (simple randomisation [flipping a coin]) with participating schools receiving either the connected brush and text messages or receiving only the connected brush. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hum by Colgate Smart toothbrush |
| Primary outcome measure | Feasibility of using a smart, electric brush by children, assessed using: 1. Consent rate recorded as the number of participants consented at 2 weeks following the initial approach by the study team 2. Recruitment rate recorded as the number of participants who completed at least one of the study surveys post-consent (post-baseline) 3. Recruitment pathways for future studies recorded as the number of new sites (first time involved in research studies) taking part in the study 4. Acceptability of the interventions on schools and parents recorded at follow-up through surveys and brief feedback interviews |
| Secondary outcome measures | 1. Knowledge, attitudes and practices regarding oral health measures by a KAPs questionnaire at baseline and end of follow-up 2. Oral hygiene practices measured by a brief oral hygiene survey at baseline, 1-week, 1-month, 2-month and 3-month follow-up |
| Overall study start date | 06/09/2022 |
| Overall study end date | 05/08/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 11 Years |
| Sex | Both |
| Target number of participants | 600 |
| Total final enrolment | 400 |
| Participant inclusion criteria | 1. Children enrolled and attending primary schools in Greater Manchester aged 8 to 11 years 2. Participants must have WIFI in their home and a smart device that is compatible with the toothbrush and app. Access to Apple iPhone (newer than 8) or iPad (newer than 5th generation) or Android users (running Android 6.0 and up) with access to an Internet connection 3. Not having previously used the smart, electric brush that is distributed during the study |
| Participant exclusion criteria | 1. Concurrent participation in another oral health clinical study 2. Any oral or general health condition which may preclude the participation of the child in the study, as determined by the parent/caregiver 3. Current or previous use of the Hum by Colgate Toothbrush by the child |
| Recruitment start date | 01/03/2023 |
| Recruitment end date | 01/05/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Harpurhey
Manchester
M9 5XR
United Kingdom
Longsight
Manchester
M13 0QX
United Kingdom
Manchester
M22 0WW
United Kingdom
Manchester
M9 8QP
United Kingdom
Manchester
M14 6HW
United Kingdom
Wythenshawe
M22 0NT
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Phone | +44 (0)161 306 6000 |
|---|---|
| fbmhethics@manchester.ac.uk | |
| Website | http://www.manchester.ac.uk/ |
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Following completion of the study, the results may be published in peer-reviewed scientific journals, as an internal report or publications on websites. A brief, user-friendly summary of data will be provided to all participating schools. Participants can request a copy of the study results using the contact details provided on the participant information sheet. |
| IPD sharing plan | Datasets generated during and/or analysed during the current study will be available upon request from Dr George Kitsaras (georgios.kitsaras@manchester.ac.uk). Data will be shared depending on the nature of the request, only anonymised data will be shared. Data relating to the smart toothbrush will not be shared as they might involve IP not publicly available. Data can be requested at any point once analyses are completed (start of 2024). All participants have provided written consent. Data to be shared will be fully anonymised. Legal restrictions apply to IP-related data which will not be shared publicly. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/02/2025 | 13/02/2025 | Yes | No |
Editorial Notes
13/02/2025: Publication reference added.
09/01/2024: Internal review.
24/08/2023: Study's existence confirmed by the University of Manchester Proportionate UREC.
