An investigation into a measure of oral cleanliness and its usefulness in motivating children towards improved oral hygiene

ISRCTN ISRCTN10044161
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

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
Email R&E@ubht.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study hypothesisOur 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
ConditionOral Health: Oral hygiene
InterventionThe 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 typeOther
Primary outcome measureChanges in oral debris (cleanliness).
Secondary outcome measuresInter- and intra-examiner variability.
Overall study start date01/10/2006
Overall study end date01/10/2007

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit5 Years
Upper age limit6 Years
SexNot Specified
Target number of participantsApprox 80 patients
Participant inclusion criteria1. 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 criteria1. 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 date01/10/2006
Recruitment end date01/10/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

C/O Research and Effectiveness Department
Bristol
BS2 8HW
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan