Condition category
Oral Health
Date applied
01/10/2010
Date assigned
06/12/2010
Last edited
02/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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 student’s 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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Hall

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

00000053

Study information

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

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

Fife and Forth Valley Research Ethics Committee, ref: 10/S0501/43

Study design

Randomised controlled cluster trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

31/10/2010

Overall trial end date

01/09/2011

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Dental outreach clinic patients over 16 years, with at least one natural tooth

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1500

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

United Kingdom

Trial participating centre

Department of Restorative Dentistry
Dundee
DD1 4HN
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Other

Funder name

Added 02/09/2014:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Scottish Dental Practice Based Research Network (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Tayside Academic Health Science Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes