Condition category
Oral Health
Date applied
09/03/2020
Date assigned
14/04/2020
Last edited
14/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Twice daily toothbrushing is recommended to prevent gum disease and tooth decay. However, it has been reported by dentists that many people fail to brush for two minutes, twice a day. Researchers are interested in other ways to improve toothbrushing outside of the dental practice setting. From other research, it is clear that connected toothbrushes are a way to engage users in improving their oral health and have the ability to produce data that has never been captured before. For example, connected toothbrushes can report how often someone brushes their teeth whereas previously this would have been reported by the individual themselves which is often not accurate. Furthermore, connected brushes and their apps can offer different brushing modes – such as coaching – which are available with instructions and challenges designed to improved brushing habits even more.
The aim of this study is to evaluate the data that is produced by the brush (how often a user brushes, how long and how well) by comparing groups that brush with and without a connected brushing app. This data will also be compared to levels of plaque and gingivitis as assessed by a dentist.

Who can participate?
Healthy adults aged 18 to 65 years old (inclusive) will be eligible for this study. Participants need to be in good dental health, with no signs of advanced gum disease or dental decay. Participants must also own a smartphone with access to Wi-Fi.

What does the study involve?
The study will last for 6 weeks, with a total of three visits. Participants will be randomly divided into two groups – offline brushing and connected brushing. Both groups will receive a study toothbrush which is to be used throughout the course of the study. One group will be expected to brush with the connected brushing app for the duration of the study (in Coach+ mode). All participants will undergo a dental assessment at two out of the three visits (plaque, gingivitis and 3D scanning) and complete a questionnaire at all three visits.

What are the possible benefits and risks of participating?
There are minimal risks to taking part. There may be some inconvenience with the three visits but the examiners are experienced clinicians and visits will be booked using the practice appointment system to ensure timing is on track and amount of time needed is minimised. Participants will be reimbursed for their time. Participants may enjoy using the connected toothbrush and will be able to keep the brush at the end of study.

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

When is the study starting and how long is it expected to run for?
December 2019 to June 2020

Who is funding the study?
The University of Manchester (UK)

Who is the main contact?
Kate McKenzie
kate.mckenzie@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate McKenzie

ORCID ID

http://orcid.org/0000-0002-8364-7381

Contact details

Dental Health Unit
Williams House
Lloyd Street North
Manchester Science Park
Manchester
M15 6SE
United Kingdom
+44 (0)161 226 1211
kate.mckenzie@manchester.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NHS001656, IRAS 268892

Study information

Scientific title

A randomised controlled trial to assess changes in oral hygiene resulting from the use of a connected manual toothbrush and smartphone application

Acronym

Study hypothesis

Use of a connected toothbrush and associated smartphone application (providing both coaching and feedback) improves oral health over a 6-week period.

Ethics approval

Approved 04/03/2020, Wales REC 7 (Public Health Wales, Building 1, Jobswell Road, St David’s Park, Carmarthen, SA31 3HB; +44 (0)1267 611164, +44 (0)1874 615949; Wales.REC7@wales.nhs.uk), ref: 20/WA/0074

Study design

Single-centre single-blind two-cell parallel-group randomized controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Plaque and gingivitis

Intervention

The study utilises a randomised, parallel, two-group design.

Advertisements, in the form of posters, will be placed at the dental practice one month before the start of the study. If participants would like to participate in the study they can speak to a member of the research team at the research site (local dental nurse or local dentist). The member of the research team (local dental nurse) will provide potential participants with an information sheet with further detail on the study. Potential participants interested in taking part will be provided with an appointment to return for screening and recruitment.

All potential subjects will undergo a screening visit prior to the study date. Upon successful recruitment, subjects will participate in this clinical trial for 6 weeks, compromising of a baseline visit, an interim visit (at week 3) and a final examination visit (at week 6). We would expect each visit to last no more than 40 min per participant with the exception of the interim study visit which may take less time (15-20 min) due to no clinical indices being measured.

At the screening visit (Day 0 Visit), the participant will have the opportunity to discuss the study in detail with a member of the research team (local dentist). Should the participant indicate a willingness to take part, they will be asked to sign an informed consent form. The examiner (local dentist) will carry out a brief dental exam to assess if the participant meets the inclusion criteria, this examination involves the use of an overhead operating light, a dental mirror and a dental probe.

Screening and Enrollment (V0), Day -21 to -7 - Selection criteria applied, informed consent procedure, Medical History, Oral Soft Tissue Assessment. Participants who are successfully recruited will be provided with toothpaste for use throughout the study (Colgate Cavity Protection, 1450 ppm Fluoride Toothpaste, provided by local dental nurse). This toothpaste is available commercially without a prescription.

Baseline visit (V1), Day 0 - Medical History, Oral Soft Tissue Assessment, Gingivitis Scoring, Plaque Scoring, Intra-oral scan (for a sub-set), Randomised into control or test group, provision of M1 toothbrush, carry out first brushing session in clinic, ensure brushing sessions have synced to smartphone application and patient-reported experience questionnaire completed.

Second visit (V2), Week 3 - Medical History, Oral Soft Tissue Assessment, ensure brushing sessions have synced to smartphone application and patient-reported experience questionnaire completed.

Final visit (V3), Week 6 - Medical History, Oral Soft Tissue Assessment, Gingivitis Scoring, Plaque Scoring, Intra-oral scan (for a sub-set), ensure brushing sessions have synced to smartphone application, patient-reported experience questionnaire completed and undergo dental polish (optional).

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

1. Plaque levels assessed using Rustogi Modified Plaque Index at baseline and 6 weeks
2. Gingivitis level assessed visually using Modified Gingival Index (MGI) at baseline and 6 weeks

Secondary outcome measures

1. Brushing duration assessed using the app at baseline visit, 3 weeks and 6 weeks
2. Surface coverage assessed using the app at baseline visit, 3 weeks and 6 weeks
3. Brushing frequency assessed using the app at 3 weeks and 6 weeks
4. Perceived value at the individual level through collection of patient-reported experience measures (PREMS) using a previously validated 15-point oral health and brushing questionnaire at baseline, 3 weeks and 6 weeks
5. Diagnostic utility of the 3D intraoral scans for the measurement of plaque and gingivitis levels intraorally assessed using a TRIOS intraoral scanner at baseline and 6 weeks

Overall trial start date

05/12/2019

Overall trial end date

26/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female subjects aged 18 to 65 years inclusive
2. Available for the 6-week study duration
3. Have a smartphone and are familiar with using smartphone applications
4. Access to Wi-Fi where they are performing oral hygiene
5. Minimum of 20 natural teeth, including 1 molar in each quadrant, with no extensive restorations present i.e. no crowns, no fillings covering multiple surfaces (excluding 3rd molars)
6. Initial gingival assessment with at least 4 bleeding sites
7. Able to read, understand and agree to the informed consent procedure
8. Able to tolerate an oral examination by a dental professional
9. Good general health

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

120 participants to be included; 60 participants recruited to allow for drop out

Participant exclusion criteria

1. Fixed orthodontic appliances, including orthodontic bands that interfere with any clinical assessment (plaque scoring)
2. Presence of partial removable dentures
3. Five or more decayed, untreated dental sites (cavities)
4. Advanced periodontal disease, with oral lesions or periodontal pockets >5.5 mm (gum disease)
5. Medical condition which requires pre-medication prior to dental visits/procedures
6. Use of drugs that can affect salivary flow
7. Use of antibiotics 1 month prior to or during this study
8. Allergy to common dentifrice ingredients
9. Pregnant or breastfeeding
10. Unable to attend all 3 visits
11. Have a cognitive impairment that prevents participation in the informed consent procedure
12. Have participated in any other oral care study or consumer/panel test within the last 3 months

Recruitment start date

21/04/2020

Recruitment end date

07/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Windsor Dental
Denhill House Denhill Road Hulme
Manchester
M15 5NR
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Faculty Research Practice Governance Coordinator
Faculty of Biology
Medicine and Health
Room 5.012
Carys Bannister Building
University of Manchester
Oxford Rd
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 5436
fbmhethics@manchester.ac.uk

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

University of Manchester

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Following completion of the study, the results will be published in peer-reviewed scientific journals, as an internal report, publications on websites and at suitable conferences as appropriate. Participants can request a copy of the study results using the contact details provided on the participant information sheet. A copy of the results will also be provided to the study site.

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

Intention to publish date

01/07/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/03/2020: Trial's existence confirmed by HRA and Health and Care Research Wales.