Condition category
Oral Health
Date applied
01/08/2016
Date assigned
08/08/2016
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Gum disease (periodontal disease) is a long-term condition in which the gums are inflamed (swollen). It is caused by the buildup of plaque (a sticky, colorless film of bacteria and sugars) on the teeth. Treatment of the gum disease usually involves controlling plaque levels by professional teeth cleaning and improving dental hygiene in the patient. The extent to which patients follow suggested oral hygiene advice has a major impact on the long-term success of the treatment. One of the many factors that may motivate people to follow through advice they receive from the dentist, may be the extent to which they believe they are at risk of developing gum disease. The aim of this study is to look at whether giving patients information about their risk of gum disease and helping them to monitor their oral hygiene, might affect how well they feel able to follow professional advice about their oral health.
Who can participate?
Adults who have been previously assessed by a dentist as having moderate to poor oral hygiene.

What does the study involve?
Participants are randomly allocated to one of three groups. During a routine clinical examination at the first visit, patients complete some brief questionnaires about their throughts and feelings about gum disease as well as their routine brushing and flossing behaviours. Those in group one receive standard care, which involves the dentist or hygienist takes patients through an explanation of periodontal disease and what they can do to control it using the clinic’s usual guidance. Those in group two receive the same as group one with the addition of being given information about their personal risk of developing gum disease. Those in group three receive the same as group two with the addition of a brushing and flossing diary and advice on how to form a goal to improve their brushing and flossing. Participants in all groups attend a further two clinic visits, 4 and 12 weeks later, for a checkup. During the 12 week visit, patients are asked to complete the same brief questionnaires they completed at the beginning of the study.

What are the possible benefits and risks of participating?
There are no particular individual benefits in taking part in this study but participants may improve their knowledge about gum disease and could improve their oral hygiene. There are no notable risks involved with participating.

Where is the study run from?
Merivale Dental Practice (UK)

When is the study starting and how long is it expected to run for?
August 2014 to October 2016

Who is funding the study?
Oral and Dental Research Trust (UK)

Who is the main contact?
Dr Koula Asimakopoulou

Trial website

Contact information

Type

Scientific

Primary contact

Dr Koula Asimakopoulou

ORCID ID

Contact details

Kings College London
Floor 18 Guys's Tower
Guy's Hospital
Great Maze Pond
London
SE1 9RW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GPS_ODRT

Study information

Scientific title

The effects of goal-setting, planning and self-monitoring (GPS) on behavioural and periodontal outcomes- a randomised controlled trial (RCT)

Acronym

Study hypothesis

A psychological intervention based on individualised risk communication goal setting and planning improves psychological and clinical outcomes in patients seeking periodontal treatment, compared to treatment as usual.

Ethics approval

King's College London Biomedical Sciences, Dentistry, Medicine and Natural & Mathematical Sciences, Research Ethics Subcommittee (BDM RESC), 14/09/2015, ref: HR-14/15-1739

Study design

Interventional randomised single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Periodontal disease

Intervention

Participants are randomised to one of three groups using a random digit generator.

Treatment as usual group: Patients receive a standard routine consultation
Risk communication group: Patients receive their standard routine consultation but they are also shown information about their gum disease risk score, that has been calculated using Previser, a software package that works out risk of periodontal disease.
GPS group: Patients receive the intervention described in Arm 2 but they are also instructed to form a goal on how they will brush and floss in the near future, along with a brushing and flossing diary that they are asked to keep until their follow up visit.

Participants in all groups are followed up after 4 and 12 weeks. Follow up involves measuring plaque and bleeding scores as well and self-reported brushing, flossing and thoughts about periodontal disease.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Plaque and bleeding are measured using standard plaque and bleeding scores at baseline, 4 and 12 weeks post intervention.

Secondary outcome measures

1. Thoughts about periodontal disease are measured using a self-report questionnaire designed for this study at baseline and 12 weeks
2. Brushing and interdental cleaning are measured using a self-report questionnaire designed for this study at baseline, 8 and 12 weeks
3. Pocket depth is measured in mm using dental probing at baseline and 12 weeks

Overall trial start date

01/08/2014

Overall trial end date

30/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Previously been assessed by their treating dentist as having moderate or poor oral hygiene

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

25 per arm

Participant exclusion criteria

1. Current smokers or those who have smoked within 30 days prior to the commencement of the study
2. Those who have a medical condition or who take medication likely to affect periodontal condition
3. Those with presence of diagnosed gingival overgrowth
4. Known psychiatric co-morbidity or physical disability judged to impair their ability to clean their teeth
5. Those who currently use antiseptic mouthwash or take antibiotics

Recruitment start date

15/10/2015

Recruitment end date

30/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Merivale Dental Practice
Merivale Dental Practice 94 Greenwich High Road
London
SE10 8JE
United Kingdom

Sponsor information

Organisation

Kings College London

Sponsor details

Floor 18 Guys's Tower
Guy's Hospital
Great Maze Pond
London
SE1 9RW
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Research organisation

Funder name

Oral and Dental Research Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

Intention to publish date

30/10/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/08/2016: Participant information sheet uploaded.