Hygiene-therapists undertaking the RDE of low-risk NHS dental patients (pilot)

ISRCTN ISRCTN70032696
DOI https://doi.org/10.1186/ISRCTN70032696
Secondary identifying numbers 36996
Submission date
23/04/2018
Registration date
30/04/2018
Last edited
13/08/2021
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
Over one half of all dental 'check-ups' result in no further treatment. The patient is examined by a General Dental Practitioner (GDP) and returned to the recall list for a further 'check-up' in another 6 or 12 months’ time. As the oral health of regular dental attenders improves further, it is likely that increasingly more patients will be 'low-risk' and will only require a simple 'check-up' in the future, with no further treatment. The use of the GDP to undertake the routine dental 'check-up' is becoming a costly way of providing care. Research has shown that other less expensive members of the dental team, known as Hygiene-Therapists (H-Ts), are just as good at detecting dental decay, gum disease and oral cancer. Using H-Ts in this way could help free up the GDPs’ time to concentrate on more complex cases. It could also free up resources to treat patients who currently don’t access care and meet the future challenges for NHS dentistry, like the growing number of house-bound elderly. The aim of this study is to explore this over a 15-month period to inform the design of a larger study.

Who can participate?
NHS patients aged over 18 who have presented with no more than one active lesion in the last year or required no more than one dental filling due to dental caries within the previous year (as of 04/10/2018)

What does the study involve?
Participants are randomly allocated to have a check-up with either a dentist or a H-T. At the end of the study their oral health is assessed (gum disease, oral cleanliness and tooth decay). At the same time, interviews explore GDPs', H-Ts’ and patients’ views to improve understanding about what could work well, how and under which conditions.

What are the possible benefits and risks of participating?
The results will be used to plan for a full-scale study. Participants receive a £25 (as of 04/10/2018) voucher from the study team for participating in the study.

Where is the study run from?
1. Cheshire & Merseyside Area Team (UK)
2. Greater Manchester Area Team (UK)

When is the study starting and how long is it expected to run for?
October 2017 to July 2019

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Paul Brocklehurst

Contact information

Prof Paul Brocklehurst
Scientific

NWORTH Clinical Trials Unit
Bangor
LL57 2PZ
United Kingdom

ORCiD logoORCID ID 0000-0003-1878-9030

Study information

Study designRandomised; Interventional; Design type: Treatment, Diagnosis, Prevention, Process of Care, Management of Care
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet ISRCTN70032696_PIS_HEA_V2_30Sep2017.docx
Scientific titleCan Hygiene-Therapists maintain the oral health of routine low-risk dental recall patients in "high-street" dental practices: a pilot study
Study objectivesOver one half of all dental 'check-ups' result in no further treatment. The patient is examined by a General Dental Practitioner (GDP) and returned to the recall list for a further 'check-up' in another six or twelve months’ time. As the oral health of regular dental attenders improves further, it is likely that increasingly more patients will be 'low-risk' and will only require a simple 'check-up' in the future, with no further treatment. The use of the GDP to undertake the routine dental 'check-up' is becoming a costly way of providing care.

Research undertaken by the same team has shown that other less expensive members of the dental team, known as Hygiene-Therapists (H-Ts), are just as good at detecting dental decay, gum disease and oral cancer. Using H-Ts in this way could help free up the GDPs’ time to concentrate on more complex cases, pursuant to their skill-set. It could also be a model of care that could be used to free up resources to treat patients who currently don’t access care and meet the future challenges for NHS dentistry, like the growing number of house-bound elderly.

To explore this, a pilot study is proposed over a 15-month period. This will inform the design of a definitive trial.
Ethics approval(s)East Midlands REC, 09/11/2017, REC ref: 17/EM/0365, IRAS: 226296
Health condition(s) or problem(s) studiedSpecialty: Oral and Dental Health, Primary sub-specialty: Oral and dental public health; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oral cavity, salivary glands and jaws
InterventionThe current practice of using dentists to provide 'check-ups' will form the control arm and will be compared to the new model, where dental 'check-ups' and any subsequent treatment will be provided by H-Ts. At the end of the study, differences in oral health will be assessed using accepted measures of 'gum' disease, oral cleanliness and tooth decay. At the same time as the trial, parallel interviews will explore GDPs', H-Ts’ and patients’ views to improve understanding about what could work well, how and under which conditions.
Intervention typeOther
Primary outcome measureProportion of sites that bleed on probing (measured at six sites per tooth) at 15 months
Secondary outcome measuresMeasured at 15 months:
1. Proportion of sites that have visible plaque present (measure of oral cleanliness)
2. Proportion of sites with a probing depth that exceeds Code 2 of the Basic Periodontal Examination periodontal probe
3. Number of new decayed and filled teeth
4. Unplanned visits between RDEs
5. Oral health related quality of life (Oral Health Impact Profile)
6. Patient-centred outcomes to explore behaviour change and dental anxiety through the use of validated questionnaires
Overall study start date01/10/2017
Completion date31/07/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 216; UK Sample Size: 216
Total final enrolment217
Key inclusion criteriaCurrent participant inclusion criteria as of 04/10/2018:
1. NHS adult patient (aged at least 18 years of age) on the recall list of the practice
2. Has presented with no more than one active lesion in the last year or required no more than one dental filling due to dental caries within the previous year (defined as "low-risk”)
3. Asymptomatic at time of the ‘check-up’
4. Have no predisposing medical history that elevates risk status
5. Were seen for their routine recall at least six months ago
6. Dentate or partially dentate


Previous participant inclusion criteria:
1. NHS adult patient (> 18 years of age) on the recall list of the practice
2. Have not presented with any active dental decay or required any dental fillings due to dental caries within the previous two years (defined as "low-risk")
3. Asymptomatic at time of the RDE
4. Dentate or partially dentate
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/03/2018
Date of final enrolment31/07/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Cheshire & Merseyside Area Team
Chester
CH2 1BQ
United Kingdom
Greater Manchester Area Team
Manchester
M1 3BN
United Kingdom

Sponsor information

Bangor University
Hospital/treatment centre

c/o Prof. Christopher Burton
School of Healthcare Sciences
Fron Heulog
Bangor
LL57 2EF
Wales
United Kingdom

ROR logo "ROR" https://ror.org/006jb1a24

Funders

Funder type

Government

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/01/79

No information available

Results and Publications

Intention to publish date31/07/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planJournals and presentations to national and international academic conferences, including the International Association of Dental Research and the British Association for the Study of Community Dentistry. The research team also has strong links with policy makers in Europe and they aim to present their findings at a meeting of EU Chief Dental Officers (CDO) (PRB has a direct link with the CDO from Wales, England, Scotland and The Netherlands). The research team will work with dental professional groups including the British Dental Association, British Society of Dental Hygiene-Therapists and the British Association of Dental Therapists. They will also disseminate the results within the commissioning networks in Public Health England, NHS England and to Consultants in Dental Public Health.

Given the strength of the programme in relation to important policy initiatives in England and Wales (Five Years Forward and Prudent Healthcare), direct links will be made with Ministers for Health, through the respective CDOs. The trialists will host a seminar to present the results and discuss their implications.

They will also produce lay summaries of the outputs of the project for presentation on the University website and issue press releases in agreement with NIHR. In addition they want to develop new and novel methods to support dissemination in a more accessible way for a lay audience. One approach will be to record a ‘virtual abstract’ video to post on University and NHS websites and promulgate via patient networks. The patient group for the study will be directly involved with this and will also create public-friendly summaries of the research.
IPD sharing planAnonymised data will be stored according to Bangor regulations (Bangor server). See https://www.bangor.ac.uk/planning/InfSecGuid.php.en

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V2 30/09/2017 30/04/2018 No Yes
Participant information sheet version V1 02/03/2018 30/04/2018 No Yes
Participant information sheet version V3 07/11/2017 30/04/2018 No Yes
Protocol file version V4 02/03/2018 30/04/2018 No No
Results article 01/02/2021 13/08/2021 Yes No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN70032696_PIS_HEA_V2_30Sep2017.docx
Uploaded 30/04/2018
ISRCTN70032696_PIS_HEAQ_V1_02Mar2018.docx
Uploaded 30/04/2018
ISRCTN70032696_PIS_patient_V3_07Nov2017.docx
Uploaded 30/04/2018
ISRCTN70032696_PROTOCOL_V4_02Mar2018.docx
Uploaded 30/04/2018

Editorial Notes

13/08/2021: Internal review.
26/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
04/10/2018: The following changes have been made to the trial record:
1. The participant inclusion criteria have been updated
2. The recruitment end date has been changed from 31/08/2018 to 31/07/2018
3. Two changes have been made to the plain English summary:
3.1. For "Who can participate?", "NHS patients aged over 18 who have had no tooth decay or fillings within the previous two years (defined as "low-risk")" has been changed to "NHS patients aged over 18 who have presented with no more than one active lesion in the last year or required no more than one dental filling due to dental caries within the previous year"
3.2. For "what are the possible benefits and risks of participating?", "Participants receive a £20 voucher" has been changed to "Participants receive a £25 voucher"
30/04/2018: Uploaded protocol Version 4, 2 March 2018 (not peer-reviewed)