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ISRCTN
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ISRCTN10044161
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ClinicalTrials.gov identifier
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Public title
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An investigation into a measure of oral cleanliness and its usefulness in motivating children towards improved oral hygiene
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0264192972
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Oral Health: Oral hygiene
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2006
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Anticipated end date
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01/10/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Approx 80 patients
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Interventions
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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.
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Primary outcome measure(s)
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Changes in oral debris (cleanliness).
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Secondary outcome measure(s)
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Inter- and intra-examiner variability.
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Sources of funding
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United Bristol Healthcare NHS Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Peter
Crawford
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Address
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C/O Research and Effectiveness Department
Level 1, Old Building
Bristol Royal Infirmary
Marborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 0117 928 3473
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Fax
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+44
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Email
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R&E@ubht.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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22/10/2007
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Date ISRCTN assigned
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28/09/2007
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