Condition category
Oral Health
Date applied
08/02/2018
Date assigned
26/02/2018
Last edited
22/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of this study is to look at different ways a dentist can give information and advice to patients, to find out which methods are most helpful to patients in improving their oral hygiene. This information will be passed on to dental professionals, giving them additional tools to help their patients succeed in improving their oral health.

Who can participate?
Healthy volunteers aged 18 or over attending a general dental practice for a check-up or review appointment with a dental professional

What does the study involve?
Participants are required to attend two review appointments. These appointments are referred to as Visit 1 and Visit 2 for the study and are 3 months apart. Participants undergo a short clinical exam as part of Visit 1 that lasts about 10 minutes. The dentist begins by examining the health of the participant’s gums by placing a dental instrument used by all dentists around the gum. The dentist records whether the gums around any of the teeth are bleeding, and gives the participant an overall score known as a bleeding score. This test is routinely carried out by dentists. Next, the dentist applies some Vaseline to the lips and uses a small brush to paint a solution onto the teeth which highlights pink and blue areas in the mouth. This shows the dentist where plaque is present and allows them to determine plaque scores. The bleeding score and plaque index together can be used to determine whether participants are high risk or low risk for oral disease. Participants are randomly allocated by the dentist to receive 1 of 8 possible oral hygiene advice programs, with each program tailored to either low or high risk of oral disease. The participants are asked to complete a questionnaire relating to their current oral hygiene routine and also record if the participant is a smoker. If participants are allocated to the enhanced oral hygiene treatment group, they may be asked to complete additional questionnaires relating to their current attitudes relating to oral health and are also asked to sign a Gum Health Improvement Patient Agreement. This agreement is between the patient and the dentist to help improve the participant’s current oral health as a combined effort. Depending on which program participants are allocated to, they may also receive a power toothbrush to use which includes the downloading of an app onto a smartphone which monitors their use of the power brush. If participants are allocated to a power toothbrush, they receive full manufacturer’s instructions for use. The power brush provided is commercially available and the app works via Bluetooth with a smartphone. Participants are asked to share their toothbrushing activity with the study team directly from the app via email. Participants are asked to return to the dental practice 3 months after their initial visit where the dentist reassesses bleeding and plaque scores, and invites participants to give feedback via a questionnaire on the advice they were given and whether the participants thought it led to an improvement in their oral health.

What are the possible benefits and risks of participating?
Where patients are allocated a power toothbrush and asked to use a smartphone app, the patients need to feel confident they are able to use this. Before allocation to the power brush, all patients are asked if they have access to a power brush and are confident in the use of apps. The clinical exam is undertaken by a qualified foundation year dentist or a hygienist who has received additional training in the clinical scores that are to be recorded and the motivational behavioural intervention to be delivered to the test group patients. The conditions are scored as they would be in a standard clinical exam. All data collected is anonymised, participants being allocated a study number on enrolment, and only anonymised data will be published. The study adds some time to the appointments of patients and the patient is required to attend again in three months’ time for a second visit, but this is explained to the patient when they are approached to take part and they can decline participation if they do not have time to spare without this affecting their care in any way.

Where is the study run from?
Bristol Dental School & Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2017 to August 2018

Who is funding the study?
Procter and Gamble (USA)

Who is the main contact?
Prof. Nicola West

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nicola West

ORCID ID

http://orcid.org/0000-0002-9127-5530

Contact details

School of Oral & Dental Science
Bristol Dental School & Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2855

Study information

Scientific title

Behavioural motivation to enhance adherence to oral hygiene recommendations for patients in general dental practice

Acronym

Study hypothesis

This project will assess whether behavioural motivation to enhance adherence to oral hygiene is more effective in improving oral hygiene in patients at high or low risk of oral disease compared to standard oral health instruction where patients are provided with simple instruction alone. A further aim of this study is to assess if the young foundation dentists and hygienists have found the motivational oral hygiene advice training of benefit to them thus providing them with additional tools to help their patients succeed in maintaining oral health.

Ethics approval

South Central - Hampshire B Research Ethics Committee, 12/12/2017, IRAS: 235629

Study design

Cluster randomised 8-treatment parallel study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Improving oral hygiene with different interventions

Intervention

There will be a total of 8 treatment groups. These will be comprised of a ‘Test’ group and a ‘Control’ group, each stratified to low and high risk relating to oral disease. There will be a further subset of these groups that will receive a power toothbrush. The treatments will be allocated through a cluster randomised design in a 2:1 ratio (in favour of the test group). Since randomization will occur at the site (cluster) level, patients treated by different DFT/hygienist within each site will all be allocated to either experimental or control intervention at the site (cluster) level. All patients will be stratified as to either high or low risk relating to oral disease. The level of risk will be determined by bleeding on probing scores as part of the clinical examination.
Participants will be enrolled onto the study and allocated a unique identification number. The allocated number will be sequential.

To complete this study, participants will be required to attend two appointments with their dentist. These appointments will be referred to as Visit 1 and Visit 2 for the study and will be 3 months apart. Following Visit 2, the study will be completed for each participant. The participants will remain under the care of their dentist and normal routine and treatment appointments will continue as planned.

Test group:
Low risk: patients will receive:
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Oral Health Information Sheet - Visit 1 only
• Access to oral health instructional videos relating to patients current oral hygiene regimen (Appendix 3)
OR
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Oral Health Information Sheet - Visit 1 only
• Provision of a power toothbrush with review of manufacturers instructions for use including smartphone App and access to power brushing instructional video - Visit 1 only

High risk: patients will receive:
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Oral Health Information Sheet - Visit 1 only,
• Gum Health Improvement Patient Agreement - Visit 1 only
• Access to oral health instructional videos dependent on patients current oral hygiene regimen
• Patient attitude questionnaire - Visit 1 and 2
OR
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Oral Health Information Sheet - Visit 1 only
• Gum Health Improvement Patient Agreement - Visit 1 only
• Patient attitude questionnaire - Visit 1 and 2
• Provision of a power toothbrush with review of manufacturers instructions for use including smartphone App and access to power brushing instructional video

Control group:
Low risk: patients will receive:
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Individualised oral hygiene advice related to risk of oral disease as learnt in dental school and currently practiced - Visit 1 only
OR
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Individualised oral hygiene advice related to risk of oral disease as learnt in dental school and currently practiced - Visit 1 only
• The provision of a powered toothbrush and manufacturers instructions

High risk: patients will receive:
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Individualised oral hygiene advice related to risk of oral disease as learnt in dental school and currently practiced - Visit 1 only
OR
• Patient self reported Oral Health Questionnaire - Visit 1 and 2
• Individualised oral hygiene advice related to risk of oral disease as learnt in practice and currently practiced - Visit 1 only
• The provision of a powered toothbrush and manufacturers instructions

The primary outcome is the change from baseline to 3 months in bleeding probing expressed as a percent. This will be analysed using a mixed effects model suited to a cluster randomized design with random effects for sites and effects for subjects within sites (i.e. clusters). The 95% CI along with the mean difference in mean bleeding probing will be reported along with unadjusted p-values. The analyses will be repeated for each strata and will also include covariates for stratification and demographic (and baseline) factors. For the subgroup of subjects given a power brush, a separate analysis will be undertaken to compare effects within this group with the appropriate covariates. The primary outcome will also be summarized (using summary statistics) by intervention group, cluster, strata and where appropriate assessment points. In addition, for the subgroup, summary statistics will be reported separately.

Secondary outcomes will be analysed using models suited to a cluster randomized trials allowing for within and between cluster (subjects within cluster) effects. The intraclass correlation coefficient will be reported along with estimates of treatment effects and 95% CIs. All other outcomes will be summarized descriptively along with demographic and where appropriate clinical characteristics (by group and site within group). Treatment effects will be adjusted for covariates and stratification variables. Separate effects will be presented for pre-specified subgroups.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Bleeding on probing, measured using scores for each eligible tooth recorded during the oral examination at baseline (Visit 1) and 3 months (Visit 2)

Secondary outcome measures

1. Plaque scores obtained for each eligible tooth recorded during the oral examination at baseline (Visit 1) and 3 months (Visit 2)
2. Patient self-reported attitudes relating to improving oral hygiene, measured using a questionnaire in the test/high risk group at baseline (Visit 1) and 3 months (Visit 2)
3. Patient self-reported oral hygiene regimens, measured using a questionnaire at baseline (Visit 1) and 3 months (Visit 2)
4. DFTs' and hygienists' oral health knowledge and behaviour, measured using a questionnaire pre and post training and after the study has completed

Overall trial start date

25/09/2017

Overall trial end date

03/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Healthy volunteers of either gender who are attending a general dental practice for a check up or review appointment with a dental professional
2. Aged 18 or over
3. Understand and are willing, able and likely to comply with all study procedures and restrictions
4. Accept the form of the study and sign a declaration of informed consent
5. Have a minimum of 16 teeth not including implants or teeth with crowns or bridges excluding teeth with extra-coronal restorations

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

There are 780 in the control group vs 1620 in the experimental group. The number of clusters (sites) for the experimental group are 27 and for the control group are 13 (40 sites in a 2:1 ratio). The cluster (site) size (number of subjects) in the experimental group is approximately n=60 per site and the number of subjects per site in the control group is n=60 . A total of at least 40 practices (sites) are needed

Participant exclusion criteria

1. Persons incapable of responding to the questions
2. An employee of the general dental practice, and/or a family relative of the employee
3. Patients without a smartphone will not be eligible to receive a powered brush

Recruitment start date

05/02/2018

Recruitment end date

31/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glen Lea Dental Suite
20 York Road
Whetherby
LS22 6SL
United Kingdom

Trial participating centre

A2 Dental Studio
3 Effingham Square
Rotherham
S65 1AP
United Kingdom

Trial participating centre

MyDentist
133 Hessle High Road
Hull
HU4 6SB
United Kingdom

Trial participating centre

Azure Dental
121 Bawtry Road
Sheffield
S9 1UF
United Kingdom

Trial participating centre

Worthley House Dental
70 The Village Haxby
York
YO32 2HX
United Kingdom

Trial participating centre

Genix Dental
Britannia Building St George Square
Huddersfield
HD1 1LG
United Kingdom

Trial participating centre

Swabys Dental Practice
10-11 Walkergate
H17 9BZ
United Kingdom

Trial participating centre

Horbury Dental Care
Vincent House Queen Street Horbury
Wakefield
WF4 6LP
United Kingdom

Trial participating centre

Kimberworth Park Dental Practice
248 Kimberworth Park Road
Rotherham
S61 3JN
United Kingdom

Trial participating centre

Wheata Plave Dental Clinic
570 Wordsworth Avenue
Sheffield
S5 9JH
United Kingdom

Trial participating centre

Eclispe Dental Care
27 Branch Road
Batley
WF17 5SB
United Kingdom

Trial participating centre

Eccleshill Dental Surgery
9 Institute Road Eccleshill Village
Bradford
BD2 2HY
United Kingdom

Trial participating centre

Archway Dental Practice
15 High Street
Stokesley
TS9 5AD
United Kingdom

Trial participating centre

R Dental
460 Idle Road
Bradford
BD2 2AR
United Kingdom

Trial participating centre

Royd House Dental Surgery
Doncaster Road
Rotherham
S65 1DY
United Kingdom

Trial participating centre

Dental 22
Chapelgate
Retford
DN22 6PL
United Kingdom

Trial participating centre

Royd House Dental Practice
99 East Street
Huddersfield
HD3 3NF
United Kingdom

Trial participating centre

LWT Dental Care
719 Ecclesall Road
Sheffield
S11 8TG
United Kingdom

Trial participating centre

Penn Hill Dental Practice
1 Penn Hill
Yeovi
BA20 1SF
United Kingdom

Trial participating centre

Portishead Dental Practice
52 Nore Road
Portishead
BS20 6JY
United Kingdom

Trial participating centre

Moor Dental Care
7 West Street
Ashburton
TQ13 7DT
United Kingdom

Trial participating centre

North Petherton Dental Practice
46 Fore Street
North Petherton
TA6 6PZ
United Kingdom

Trial participating centre

Riverside Dental Practice
Butts Path
Braunton
EX33 2EU
United Kingdom

Trial participating centre

Dunedin Clinic
Silverdown Office Park
Exeter
EX5 2UX
United Kingdom

Trial participating centre

Chulmleigh Dental Practice Ltd,
South Molton Street
Chumleigh
EX18 7BW
United Kingdom

Trial participating centre

Matford Dental Clinic
1A The Venture Centre Yeoford Way Marsh Barton Business Centre
Exeter
EX2 8LB
United Kingdom

Trial participating centre

Browns Dental Practice
Cedar Rise Fore Street
Ivybridge
PL21 9AE
United Kingdom

Trial participating centre

Mount Wise Dental Practice
15A Cumberland Street Devonport
Plymouth
PL1 4DX
United Kingdom

Trial participating centre

Truro Dental Health
46 Lemon Street
Truro
TR1 2NS
United Kingdom

Trial participating centre

Chipping Manor Dental Practice
10 Long Street
Wotton Under Edge
GL12 7ER
United Kingdom

Trial participating centre

Wessex House Dental Practice
Westbury
Sherborne
DT9 3EH
United Kingdom

Trial participating centre

Church Street Dental Practice
7A Church Street
Wincanton
BA9 9AA
United Kingdom

Trial participating centre

Oldland Common Dental Practice
206 High Street Oldland Common
Bristol
BS30 9QW
United Kingdom

Trial participating centre

Apple Dental Practice
97 High Street Winterbourne
Bristol
BS36 1RD
United Kingdom

Trial participating centre

The Promenade Dental Practice
12 Gloucester Road Bishopson
Bristol
BS7 8AE
United Kingdom

Trial participating centre

Quedgeley House Dental Practice
39-42 Space Park Olympus Way
Quedgeley
GL2 4AL
United Kingdom

Trial participating centre

Oasis Dental Care
1A Madeira Road
Poole
BH14 9ET
United Kingdom

Trial participating centre

Wylye Valley Dentistry
1 Station Road
Warminster
BA12 9BR
United Kingdom

Trial participating centre

Dental Centre Bournemouth
11 The Triangle
Bournemouth
BH2 5RY
United Kingdom

Trial participating centre

Savernake Forest Dental Practice
Salisbury Road
Marlborough
SN8 4FD
United Kingdom

Trial participating centre

Springfield Dental Clinic
2 Springfield Road
Guiseley
LS20 8AL
United Kingdom

Sponsor information

Organisation

University of Bristol

Sponsor details

Senate House
Tyndall Ave
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Procter and Gamble

Alternative name(s)

Procter & Gamble, PandG, P&G

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

It is planned that the study will be written up and published in a high-impact peer reviewed journal. This will be approximately a year following data analysis following the end of the study.

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

03/08/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes