An investigation into a measure of oral cleanliness and its usefulness in motivating children towards improved oral hygiene
ISRCTN | ISRCTN10044161 |
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DOI | https://doi.org/10.1186/ISRCTN10044161 |
Secondary identifying numbers | N0264192972 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 14/06/2011
- 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
Not provided at time of registration
Contact information
Mr Peter Crawford
Scientific
Scientific
C/O Research and Effectiveness Department
Level 1, Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom
Phone | +44 0117 928 3473 |
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R&E@ubht.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study hypothesis | Our aims in this study are to address firstly the reproducibility of the Grubby score and secondly whether it has a motivating effect on patients. |
Ethics approval(s) | Not provided at time of registration |
Condition | Oral Health: Oral hygiene |
Intervention | The proposed study will take place at the Paediatric Department of the Dental Hospital, Bristol and will include children who come to the Hospital for tooth extraction under General Anaesthesia. These children attend on an initial visit for assessment and then, usually some 5 weeks later, for extractions. Parents will be informed that the investigators are trying to assess the usefulness of oral hygiene instruction in reducing dental plaque levels. Consent will be recorded. In the first study, the grubby score of each child will be noted down twice: once before and once after they have been sent to the x-ray department, to determine reproducibility. The same assessment will be performed on the same visit by another clinician so as to compare results on the same child and to make conclusions about the inter- and intra-examiner reproducibility. Children will be randomly separated into two groups. In the first group the 'Grubby score' of the patients will be assessed by 'sweeping' the surfaces of the nominated teeth with a blunt dental instrument. The grubby score achieved will be revealed and oral hygiene instructions will be provided, tempered to their age and intellectual ability. 'Target' scores (a reduction of 50%) will be set to achieve by a subsequent visit. For the second group, the Grubby score of the patients will be assessed. The grubby score achieved will not be revealed. Oral hygiene instructions will be provided, tempered to their age and intellectual ability. Target scores will not be set. Both groups will be told that their tooth-brushing will be re-assessed at the subsequent appointment for general anaesthesia. At the appointment for general anaesthesia, the grubby score will be repeated and the 'test' (first group) told of their achievement in terms of their grubby score and the second group informed in general terms. |
Intervention type | Other |
Primary outcome measure | Changes in oral debris (cleanliness). |
Secondary outcome measures | Inter- and intra-examiner variability. |
Overall study start date | 01/10/2006 |
Overall study end date | 01/10/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 5 Years |
Upper age limit | 6 Years |
Sex | Not Specified |
Target number of participants | Approx 80 patients |
Participant inclusion criteria | 1. Children aged between five years and six years 2. Ability to co-operate with oral examination 3. Ability to comprehend instructions in English 4. The presence of teeth at the recording sites |
Participant exclusion criteria | 1. Children aged outside five years and six years, 364 days 2. Inability to co-operate with oral examination 3. Inability to comprehend instructions in English 4. The absence of teeth at the recording sites |
Recruitment start date | 01/10/2006 |
Recruitment end date | 01/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
United Bristol Healthcare NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 |