Goal-setting, planning and self-monitoring (GPS) for gum disease
| ISRCTN | ISRCTN59696243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59696243 |
| Secondary identifying numbers | GPS_ODRT |
- Submission date
- 01/08/2016
- Registration date
- 08/08/2016
- Last edited
- 24/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Kings College London
Floor 18 Guys's Tower
Guy's Hospital
Great Maze Pond
London
SE1 9RW
United Kingdom
Study information
| Study design | Interventional randomised single-blind randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | ISRCTN59696243_PIS_25Sep15_V3.docx |
| Scientific title | The effects of goal-setting, planning and self-monitoring (GPS) on behavioural and periodontal outcomes- a randomised controlled trial (RCT) |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2014 |
| Completion date | 30/10/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 25 per arm |
| Total final enrolment | 97 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Previously been assessed by their treating dentist as having moderate or poor oral hygiene |
| Key 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 |
| Date of first enrolment | 15/10/2015 |
| Date of final enrolment | 30/04/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
94 Greenwich High Road
London
SE10 8JE
United Kingdom
Sponsor information
Other
Floor 18 Guys's Tower
Guy's Hospital
Great Maze Pond
London
SE1 9RW
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/10/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V3 | 25/09/2015 | 08/08/2016 | No | Yes |
| Results article | results | 01/09/2019 | Yes | No |
Additional files
- ISRCTN59696243_PIS_25Sep15_V3.docx
- Uploaded 08/08/2016
Editorial Notes
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
08/08/2016: Participant information sheet uploaded.
