Condition category
Oral Health
Date applied
20/03/2017
Date assigned
22/06/2017
Last edited
06/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Nearly one-in-three people choose to see a dentist only when they have a dental problem, such as toothache or abscess. Urgent dental treatment is focused on addressing pain and stabilising the problem; it is usually delivered within high-street dental practices or out-of-hours dental clinics. According to clinical guidelines, optimal treatment for urgent dental problems usually involves an intervention, such as extraction of a tooth. Prescription-only treatment plans, such as for painkillers or antibiotics, are rarely indicated. Published research provides some evidence (from interviews with clinicians) to explain why provision of urgent dental care often does not comply with clinical guidelines. The aim of this study is to identify what factors in dentist-patient interactions influence treatment during actual urgent dental appointments.

Who can participate?
Adults attending an urgent NHS dental appointment (and chaperone if used) and the clinician treating them.

What does the study involve?
All patients attend their appointments as they usually would. Each appointment is audio-recorded and the clinicians are asked to complete short questionnaires after each one. In-depth study of a selection of cases involves analysis of the recordings, observation notes and questionnaires, together with follow-up interviews with patients and clinicians.

What are the possible benefits and risks of participating?
There are no direct benefits for patient or chaperone participants; clinicians will be reimbursed for the time taken delivering the study which is in excess of time spent normally treating patients. There are no direct risks involved with participating.

Where is the study run from?
Six General Dental Practices and two Unscheduled Dental Care clinics across Lancashire and West Yorkshire (UK)

When is study starting and how long is it expected to run for?
October 2015 to March 2018

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

Who is the main contact?
Ms Wendy Thompson
dnwt@leeds.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Wendy Thompson

ORCID ID

http://orcid.org/0000-0001-6799-4087

Contact details

School of Dentistry
University of Leeds
Worsley Building
Clarendon Way
Leeds
LS2 9JT
United Kingdom
+44 113 343 9214
dnwt@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32833

Study information

Scientific title

Which factors in dentist-patient interactions influence treatment in urgent dental care?

Acronym

TRUCE

Study hypothesis

The aim of this study is to assess which factors in dentist-patient interactions influence treatment in urgent dental care.

Ethics approval

Bradford/Leeds REC, 09/02/2017, ref: 16/YH/0487

Study design

Observational; Design type: Qualitative

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Other

Patient information sheet

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

Condition

Specialty: 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

Intervention

Patient participants will be recruited when they present for urgent dental care appointments. Following initial consent (from the patient and also anyone else who they bring with them into the appointment), appointments will be observed and/or audiorecorded. Urgent NHS dental appointments usually take between 10 and 20 minutes. Patients may be contacted (up to three months after their appointment) for follow-up telephone interview which will last around 30 minutes.

Clinician participants (dentists and dental nurses) will be observed/audio-recorded during 16 dental appointment. At the end of each appointment, each clinician will complete a very short questionnaire (taking less than 30 seconds). Follow-up telephone interview with a selection of the clinicians will also take place up to three months after the appointments.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Identification of factors in the dentist:patient interaction which influence urgent dental treatment, through analysis of transcripts of urgent dental appointments; observation field notes, clinician questionnaires and Interviews with patients and clinicians.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2015

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Patient Participant Inclusion Criteria:
1. Aged over 18 years
2. Attending an urgent NHS dental appointment
3. Able and willing to provide valid consent to participate in the research

Chaperone Participant Inclusion Criteria
1. Aged over18 years
2. In attendance during an urgent NHS dental appointment
3. Able and willing to provide valid consent to participate in the research

Clinician Participant Inclusion Criteria:
1. Registered with the GDC
2. Professional indemnity is in place and covers any activity undertaken during the course of this research, including any harm to participants in the conduct of the research
3. Willing to provide valid consent to participate in the research

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 192; UK Sample Size: 192

Participant exclusion criteria

Patient Participant Exclusion Criteria:
1. Currently experiencing severe or debilitating pain or distress
2. Attending for routine dental treatment
3. Attending for private dental treatment
4. Accompanied during their appointment by a chaperone who is a minor (< 18 years)
5. Accompanied during their appointment by a chaperone who is not able and willing to provide valid consent to participate in the research.

Clinician Participant Exclusion Criteria:
1. Provides only private dental treatment to adult patients
2. Currently subject to any condition on their registration (including from the NHS England Area Team and the General Dental Council). Any registrant who subsequently becomes subject to any condition during the course of the research will agree to notify the CI in a timely fashion.

Recruitment start date

30/05/2017

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford District Care NHS Foundation Trust
New Mill Victoria Road
Bradford
BD18 3LD
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

School of Dentistry
Worsley Building
Clarendon Way
Leeds
LS2 9JT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The final study report will form part of the Chief Investigator’s PhD thesis which will be made publically available through the British Library’s EThOS (e-Theses Online Service) database; it is anticipated that this will be during 2019. Publications by the CI in high-quality, peer-reviewed dental journals are also planned in a similar timeframe. A Plain English summary of research findings will be prepared at the end of the study and made available for participating practices, clinicians, patients (who have given contact details for this during the consent process) and other patient advocacy organisations interested in the research.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Research Data Leeds.

Intention to publish date

31/12/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

06/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting. 23/06/2017: Internal review.