Extended dental services to provide oral health promotion text messages for older patients - OHP-TOP study

ISRCTN ISRCTN17331229
DOI https://doi.org/10.1186/ISRCTN17331229
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number CPMS: 41501
Sponsor University of Portsmouth
Funder NHS England
Submission date
23/09/2019
Registration date
25/09/2019
Last edited
17/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 September 2021

Who is funding the study?
NHS England

Who is the main contact?
Dr Kristina Wanyonyi
k.wanyonyi@qmul.ac.uk

Contact information

Dr Kristina Wanyonyi
Scientific

Clinical Senior Lecturer in Dental Public Health
Queen Mary University of London
Institute of Dentistry
Barts and The London School of Medicine and Dentistry
4th Floor Dental Hospital
Turner Street
London
E1 2AD
United Kingdom

ORCiD logoORCID ID 0000-0003-2320-6805
Phone +447957718679
Email k.wanyonyi@qmul.ac.uk

Study information

Primary study designInterventional
Study designRandomised; Both; Design type: Prevention, Process of Care, Education or Self-Management, Management of Care, Cross-sectional
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA pilot project to research extending dental services through the use of a text messaging intervention to improve the oral health of older patients
Study acronymOHP-TOP
Study objectivesThe 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(s)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
Health condition(s) or problem(s) studiedOral health of older patients
InterventionUPDA 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date30/09/2021

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration202
Total final enrolment150
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/05/2019
Date of final enrolment19/12/2019

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
IPD sharing planThe datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 20/05/2021 02/08/2021 Yes No
Abstract results 20/06/2022 17/01/2023 No No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Protocol file version v2 12/03/2019 25/09/2019 No No

Additional files

ISRCTN17331229_PROTOCOL_v2_12Mar2019.pdf
Uploaded 25/09/2019
37221 Abstract 2022.pdf
Abstract results

Editorial Notes

17/01/2023: Publication reference added.
02/08/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/07/2021 to 30/09/2021.
2. Publication reference added.
3. The total final enrolment number was added.
14/10/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/10/2020 to 31/07/2021.
2. The intention to publish date was changed from 31/10/2021 to 31/07/2022.
29/04/2020: The following changes have been made:
1. The scientific contact has been updated and the plain English summary has been updated to reflect this.
2. The recruitment end date has been changed from 31/10/2020 to 19/12/2019.
25/09/2019: Uploaded protocol Version 2, 12 March 2019 (not peer reviewed).
23/09/2019: Trial's existence confirmed by the NIHR.