Motivational techniques to improve oral hygiene for patients in general dental practice
| ISRCTN | ISRCTN10536130 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10536130 |
| IRAS number | 235629 |
| Secondary identifying numbers | 2855, IRAS 235629 |
- Submission date
- 08/02/2018
- Registration date
- 26/02/2018
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
School of Oral & Dental Science
Bristol Dental School & Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
 ORCID ID |
0000-0002-9127-5530 |
|---|
Study information
| Study design | Cluster randomised 8-treatment parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Behavioural motivation to enhance adherence to oral hygiene recommendations for patients in general dental practice |
| Study objectives | 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(s) | South Central - Hampshire B Research Ethics Committee, 12/12/2017, IRAS: 235629 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 25/09/2017 |
| Completion date | 30/09/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 |
| Total final enrolment | 733 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/02/2019 |
| Date of final enrolment | 30/04/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Whetherby
LS22 6SL
United Kingdom
Rotherham
S65 1AP
United Kingdom
Hull
HU4 6SB
United Kingdom
Sheffield
S9 1UF
United Kingdom
Haxby
York
YO32 2HX
United Kingdom
St George Square
Huddersfield
HD1 1LG
United Kingdom
H17 9BZ
United Kingdom
Queen Street
Horbury
Wakefield
WF4 6LP
United Kingdom
Rotherham
S61 3JN
United Kingdom
Sheffield
S5 9JH
United Kingdom
Batley
WF17 5SB
United Kingdom
Eccleshill Village
Bradford
BD2 2HY
United Kingdom
Stokesley
TS9 5AD
United Kingdom
Bradford
BD2 2AR
United Kingdom
Rotherham
S65 1DY
United Kingdom
Retford
DN22 6PL
United Kingdom
Huddersfield
HD3 3NF
United Kingdom
Sheffield
S11 8TG
United Kingdom
Yeovi
BA20 1SF
United Kingdom
Portishead
BS20 6JY
United Kingdom
Ashburton
TQ13 7DT
United Kingdom
North Petherton
TA6 6PZ
United Kingdom
Braunton
EX33 2EU
United Kingdom
Exeter
EX5 2UX
United Kingdom
Chumleigh
EX18 7BW
United Kingdom
Yeoford Way
Marsh Barton Business Centre
Exeter
EX2 8LB
United Kingdom
Fore Street
Ivybridge
PL21 9AE
United Kingdom
Devonport
Plymouth
PL1 4DX
United Kingdom
Truro
TR1 2NS
United Kingdom
Wotton Under Edge
GL12 7ER
United Kingdom
Sherborne
DT9 3EH
United Kingdom
Wincanton
BA9 9AA
United Kingdom
Oldland Common
Bristol
BS30 9QW
United Kingdom
Winterbourne
Bristol
BS36 1RD
United Kingdom
Bishopson
Bristol
BS7 8AE
United Kingdom
Olympus Way
Quedgeley
GL2 4AL
United Kingdom
Poole
BH14 9ET
United Kingdom
Warminster
BA12 9BR
United Kingdom
Bournemouth
BH2 5RY
United Kingdom
Marlborough
SN8 4FD
United Kingdom
Guiseley
LS20 8AL
United Kingdom
Sponsor information
University/education
Senate House
Tyndall Ave
Bristol
BS8 1TH
England
United Kingdom
"ROR" |
https://ror.org/0524sp257 |
|---|
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Procter & Gamble, PandG, The Procter & Gamble Company, P&G
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/11/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| 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 plan | The anonymised participant data (clinical scores and questionnaire) generated during the current study will be shared once the data has been published and will be stored in the publicly available University of Bristol Research Data Repository (https://data.bris.ac.uk/data/) with a DOI maintained for a minimum of 20 years. Data will be made available as restricted access to bonafide researchers who provide a methodologically sound proposal and evidence of ethical approval (if required), subject to the agreement of the University of Bristol Data Access Committee for analysis to achieve aims in the approved proposal. Proposals will also be subject to the prior written consent of the funder (P&G). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/10/2021 | 02/11/2021 | Yes | No | |
| Dataset | 07/12/2021 | 19/10/2022 | No | No | |
| Protocol file | version 2.0 | 10/12/2017 | 25/10/2022 | No | No |
Additional files
Editorial Notes
25/10/2022: Protocol file uploaded.
19/10/2022: Dataset added.
02/11/2021: Publication reference added.
19/10/2021: The intention to publish date was changed from 30/09/2021 to 30/11/2021.
17/03/2021: The intention to publish date was changed from 31/03/2021 to 30/09/2021.
16/11/2020: IPD sharing statement added.
19/10/2020: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2020 to 31/03/2021.
2. Total final enrolment number added.
05/05/2020: The intention to publish date was changed from 03/08/2020 to 31/12/2020.
11/02/2019: The following changes were made:
1. The recruitment start date was changed from 05/02/2018 to 05/02/2019.
2. The recruitment end date was changed from 31/03/2018 to 30/04/2019.
3. The overall trial end date was changed from 03/08/2018 to 30/09/2019.
4. The intention to publish date was changed from 03/08/2019 to 03/08/2020.
