Condition category
Oral Health
Date applied
23/09/2019
Date assigned
25/09/2019
Last edited
25/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The University of Portsmouth Dental Academy (UPDA) serves a broad range of patients for complex care, prevention, receipt of dental treatment and dental advice through a NHS contract. UPDA has previously shown that patient appointment attendance can be improved through text messaging reminders. Studies show older patients may experience a variety of barriers in accessing dental services and maintaining good oral health; including challenges complying with daily tooth-brushing behaviours. The aim of this study is to investigate the impact of extended, regular oral health advice communicated via text messages for older patients attending UPDA.

Who can participate?
Dental patients aged 65 and over from the existing pool of patients at UPDA

What does the study involve?
Participants are randomly allocated to receive dental health information via a sole leaflet or text messages over 10 weeks. All receive a dental examination and complete quality of life questionnaires at the start of the study. The text message group receive three messages per week for 10 weeks and after 6 months from the initial text, three additional text messages are sent. Also at this time, a two-way evaluation message regarding the intervention is sent to evaluate how useful they found the service. The control group only receive a single leaflet at the start of the study. After 12 months from the initial text, all participants complete quality of life questionnaires again and their dental records are examined to establish changes in dental health outcomes and dental attendance.

What are the possible benefits and risks of participating?
The findings will be submitted to the funders of the study (the NHS) to support decisions to extend services for older patients to improve oral health.

Where is the study run from?
University of Portsmouth Dental Academy (UK)

When is the study starting and how long is it expected to run for?
December 2018 to October 2020

Who is funding the study?
NHS England

Who is the main contact?
Dr Kristina Wanyonyi
kristina.wanyonyi@port.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kristina Wanyonyi

ORCID ID

http://orcid.org/0000-0003-2320-6805

Contact details

Research Lead/Senior Lecturer in Dental Public Health
Departmental Research Degrees Coordinator
NIHR CRN Wessex Oral and Dental Specialty Lead
University of Portsmouth Dental Academy
William Beatty Building
Hampshire Terrace
Portsmouth
PO1 2QG
United Kingdom
+44 (0)23 9284 5746
kristina.wanyonyi@port.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 41501

Study information

Scientific title

A pilot project to research extending dental services through the use of a text messaging intervention to improve the oral health of older patients

Acronym

OHP-TOP

Study hypothesis

The University of Portsmouth Dental Academy (UPDA) serves a broad range of patients for complex care, prevention, receipt of dental treatment and dental advice through an NHS contract. UPDA has previously shown that patient appointment attendance can be improved through text messaging reminders. Studies show older patients may experience a variety of barriers in accessing dental services and maintaining good oral health; including challenges complying with daily tooth-brushing behaviours (Borreani et al., 2008). The aim of this study is to investigate the impact of extended, regular oral health advice communicated via text messages for older patients attending UPDA.

Ethics approval

Approved 30/03/2019, East Midlands - Nottingham 1 Research Ethics Committee (The Old Chapel Royal Standard Place Nottingham NG1 6FS, UK, Tel: +44 (0)207 104 8101, +44 (0)207 104 8056; Email: NRESCommittee.EastMidlands-Nottingham1@nhs.net), ref: 19/EM/0092

Study design

Randomised; Both; Design type: Prevention, Process of Care, Education or Self-Management, Management of Care, Cross-sectional

Primary study design

Interventional

Secondary study design

Randomised controlled 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

Oral health of older patients

Intervention

UPDA sees approximately 400 patients over 65 years old. They will be recruited into this extended intervention service by a research nurse to explain the study and undertake consenting protocols. Participants will receive dental health information via a sole leaflet or text messages over 10 weeks. All will receive a dental examination and undertake quality of life questionnaires at the start of the study.

The text message intervention (TMI) group (n=101) will receive three messages per week for 10 weeks and after 6 months from the initial text, three additional text messages will be provided. Also at this time, a two-way evaluation message regarding the intervention will be sent to evaluate how useful they found the service. The control group (n=101) will only receive a single leaflet at the start of the study.

After 12 months from the initial text, all participants will complete quality of life questionnaires again and their dental records will be examined to establish changes in dental health outcomes and dental attendance.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Oral health status (clinical outcomes) measured using plaque score, bleeding index, BPE, DMFT, number of sound teeth, RAG (red, amber and green disease risk) rating at baseline and after 12 months
2. Attitude and behaviour of patients assessed using two-evaluation text message at 6 months after the intervention

Secondary outcome measures

1. Perceived oral health-related quality of life and general health measured using OHIP 14 validated questionnaire at baseline at 12 months
2. The acceptability of the text messaging interventions for this age bracket assessed using two-way evaluation text-messages at 6 months

Overall trial start date

01/12/2018

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Dental patients aged 65 and over from the existing pool of patients at UPDA
2. Dentate
3. Able to consent to this project
4. Own a mobile device capable of receiving text messages
5. Possess an acceptable level of the English language

The latter two requirements will be assessed by whether they are currently in receipt of appointment reminders. The assessment of patient capability will be on the onus of the consenting participant and the dental care team.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 202; UK Sample Size: 202

Participant exclusion criteria

1. Dental patients below 65 years old who attend UPDA
2. Dental patients who do not currently attend UPDA
3. Patients who are edentulous and patients who do not or have been deemed to not have the capacity to consent to the text messaging intervention, either by themselves or the dental care team
4. Patients who do not own a mobile phone and are therefore unable to receive text messages
5. Patients who do not possess an acceptable level of the English language

Recruitment start date

01/05/2019

Recruitment end date

31/10/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Portsmouth Dental Academy
William Beatty Building Hampshire Terrace
Portsmouth
PO1 2QG
United Kingdom

Sponsor information

Organisation

University of Portsmouth

Sponsor details

c/o Dr Simon Kolstoe
James Watson West
2 King Richard I Road
Portsmouth
PO1 2RF
United Kingdom
+44 (0)2392846206
simon.kolstoe@port.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

NHS England

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings disseminated through peer-reviewed articles, reports and the UPDA website.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/10/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/09/2019: Uploaded protocol Version 2, 12 March 2019 (not peer reviewed). 23/09/2019: Trial's existence confirmed by the NIHR.