Dental Outreach Oral Hygiene Study

ISRCTN	ISRCTN53698147
DOI	https://doi.org/10.1186/ISRCTN53698147
Secondary identifying numbers	00000053

Submission date: 01/10/2010
Registration date: 06/12/2010
Last edited: 02/09/2014

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Outreach clinics provide free dental treatment delivered by final year dental students under supervision. The clinics, which have now become widespread throughout Scotland, have been constructed in areas with low NHS dental registration levels, under the direction of the NHS Action Plan for Improving Oral Health (Scottish Executive 2005). Subsequently, these clinics provide treatment for patients with high levels of disease as a result of poor oral hygiene. Dental care providers deliver oral hygiene instruction as part of a preventive care approach. However, there currently is no clear best practice on how this instruction is best delivered. There is, however, some evidence to suggest that delivery of oral hygiene instruction using a psychological framework can improve patients oral health behaviours and therefore oral health. It has also been suggested that the inclusion of biomarker information may further increase patients oral hygiene behaviours and therefore oral health. This study aims to assess the effectiveness of oral hygiene instruction delivered within a psychological framework, with the inclusion of biomarker information, on the periodontal health of dental outreach patients.

Who can participate?
Dental outreach patients over the age of 16 with at least one natural tooth.

What does the study involve?
During routine dental outreach appointments participants will complete a short questionnaire and have their gum health examined by a final year dental student. They then will be given oral hygiene instruction; the method used will be determined by the students group allocation. Participants will return at 3 and 6 months to complete a questionnaire and have their gum health examined. Participants will be enrolled in the study for 6 months. During this time they receive normal dental care on outreach which may involve gum treatment.

What are the possible benefits and risks of participating?
Participants in the study may benefit from improving their oral health. Regular effective tooth cleaning has been proven to reduce dental disease. There are no additional risks to being involved in this study as oral hygiene instruction is something which is part of usual dental care.

Where is the study run from?
Dundee Dental Hospital and School (UK).

When is the study starting and how long is it expected to run for?
The study ran from October 2010 to September 2011.

Who is funding the study?
Scottish Dental Practice Based Research Network have funded paperwork and donated researcher time to this study. Training for the study has been donated by Tayside Academic Health Science Centre.

Who is the main contact?
Dr Andrew Hall

Contact information

Dr Andrew Hall
Scientific

Department of Restorative Dentistry
Dundee Dental Hospital and School
Park Place
Dundee
DD1 4HN
United Kingdom

Study information

Study design	Randomised controlled cluster trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised and controlled cluster trial of 1500 patients attending dental outreach facilities affiliated with the University of Dundee, investigating whether delivery of an enhanced form of oral hygiene instruction, framed using psychological theory with the inclusion of biomarker information, can influence gingival health
Study acronym	DOOHS
Study hypothesis	Providing tooth cleaning instruction enhanced by psychological theory and including biomarker information will improve the gingival health of dental outreach patients, compared to the providing the usual methods of tooth cleaning instruction.
Ethics approval(s)	Fife and Forth Valley Research Ethics Committee, ref: 10/S0501/43
Condition	Oral health
Intervention	Oral hygiene instruction delivery, enhanced by framing with a psychological framework including biomarker information (intervention), versus oral hygiene instruction delivered in the usual way (control). The treatment is a one-off intervention and patients in both control and intervention arms will be followed up for 6 months. Updated 02/09/2014: The study was stopped due to poor patient recruitment.
Intervention type	Other
Primary outcome measure	To assess the effectiveness of oral hygiene instruction delivered within a psychological framework, with the inclusion of biomarker information, on the periodontal health of primary care dental outreach patients. Measured at baseline, 3 months and 6 months.
Secondary outcome measures	Measured at baseline, 3 months and 6 months: 1. To assess the change in reported oral hygiene behaviours after this method of oral hygiene delivery 2. To investigate the acceptability of clinical research to this new group of primary care patients and the participating students
Overall study start date	31/10/2010
Overall study end date	01/09/2011
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1500
Participant inclusion criteria	Dental outreach clinic patients over 16 years, with at least one natural tooth
Participant exclusion criteria	1. Patients who are pregnant 2. Patients with completely healthy gums and no dental plaque 3. Patients who have medical disorder preventing examination of the gums
Recruitment start date	31/10/2010
Recruitment end date	01/09/2011

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Department of Restorative Dentistry

Dundee
DD1 4HN
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

c/o Dr Anne Langstone
Tayside Academic Health Sciences Centre
Ninewells Hospital Research and Development Centre
Level 2 Residency Block
Ninewells
Dundee
DD1 9SY
Scotland
United Kingdom

Website	http://www.dundee.ac.uk/
"ROR"	https://ror.org/03h2bxq36

Funders

Funder type

Other

Added 02/09/2014:

No information available

Scottish Dental Practice Based Research Network (UK)

No information available

Tayside Academic Health Science Centre (UK)

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