Early intervention dental trial

ISRCTN	ISRCTN63382258
DOI	https://doi.org/10.1186/ISRCTN63382258
Secondary identifying numbers	10105

Submission date: 04/10/2011
Registration date: 09/11/2011
Last edited: 03/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and aims
People with mental illness tend to have more dental problems than people without. Oral health problems are not well recognised by mental health professionals and when treatment is accessed, people with mental illnesses generally experience barriers to treatment.
The aim of this study is to see whether a simple checklist can improve the oral health of people with serious mental illness.

Who can participate?
Anyone aged over 18 years old who is cared for by an Early intervention in Psychosis team in Nottinghamshire, Derbyshire or Lincolnshire can take part.

What does the study involve?
Early Intervention in Psychosis teams will be randomly allocated to receive either dental awareness training for care coordinators plus using a dental health checklist with standard care or to standard care alone. All service users within the same team will receive the same intervention.

What are the possible benefits and risks of participating?
If service users agree to complete the checklist, they will gain more information about how to look after their teeth. We do not think there will be any negative side effects from the checklist.
Only people who are cared for by one of the teams on the day during which we allocate participants to one of the treatments will be able to take part, but if the checklist is found to improve the oral health of the people who completed it, every person cared for by the teams will be given the opportunity to use the checklist.

Where is the study run from?
Within psychosis teams in Nottinghamshire, Derbyshire and Lincolnshire (UK). and will be delivered as part of standard care.

When is study starting and how long is it expected to run for?
The trial started in October 2011 and will run for one year.

Who is funding the study?
The study is funded by National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC).

Who is the main contact?
Ms Hannah Jones (Research Assistant)
Hannah.Jones@Nottingham.ac.uk

Contact information

Prof Clive E Adams
Scientific

Cochrane Schizophrenia Group
Sir Colin Campbell Building
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Phone	+44 (0)115 823 1274
Email	clive.adams@nottingham.ac.uk

Study information

Study design	Multicentre cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The three Shires early intervention dental trial
Study objectives	To examine whether dental awareness training plus an oral health checklist will improve the oral health of the "Early Intervention in Psychosis" population in the East Midlands, United Kingdom
Ethics approval(s)	NRES Committee East Midlands, 1 Nottingham 11/08/2011, ref: 11/EM/0205
Health condition(s) or problem(s) studied	Oral health
Intervention	Team dental awareness training plus an oral health checklist plus standard care versus standard care alone
Intervention type	Behavioural
Primary outcome measure	Visit to dentist within one year of exposure to checklist
Secondary outcome measures	1. Registration with a dentist 2. Frequency of tooth brushing 3. Reason for dental visit (routine vs for problem) 4. Quality of life 5. Economic data 6. Leaving the study
Overall study start date	01/10/2011
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	600-800
Key inclusion criteria	1. Any willing early intervention in psychosis team in Nottinghamshire, Derbyshire or Lincolnshire 2. Service users cared for by the care coordinators within these teams aged over 18 years old at randomisation
Key exclusion criteria	1. Any early intervention in psychosis team that does not wish to take part 2. Any individual care coordinator or service user within a team that does not wish to take part 3. Any service user aged less than 18 years old at randomisation
Date of first enrolment	01/10/2011
Date of final enrolment	30/09/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cochrane Schizophrenia Group

Nottingham
NG7 2TU
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

Email	paul.cartledge@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/05/2013		Yes	No

Editorial Notes

03/10/2018: No publications found, verifying study status with principal investigator.