| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN10044161 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0264192972 |
| Public title | An investigation into a measure of oral cleanliness and its usefulness in motivating children towards improved oral hygiene |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Oral Health: Oral hygiene |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/10/2006 |
| Anticipated end date | 01/10/2007 |
| Status of trial | Completed |
| Target number of participants | Approx 80 patients |
| Interventions | 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. |
| Primary outcome measure(s) | Changes in oral debris (cleanliness). |
| Secondary outcome measure(s) | Inter- and intra-examiner variability. |
| Sources of funding | United Bristol Healthcare NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Peter Crawford |
| Contact details | C/O Research and Effectiveness Department
Level 1, Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
United Kingdom
BS2 8HW |
| Contact telephone | +44 0117 928 3473 |
| Contact fax | +44 |
| Contact email | R&E@ubht.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN10044161 |
| Date last extracted from ISRCTN register | 17/04/2008 |
