Condition category
Oral Health
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
14/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Peter Crawford

ORCID ID

Contact details

C/O Research and Effectiveness Department
Level 1
Old Building
Bristol Royal Infirmary
Marborough Street
Bristol
BS2 8HW
United Kingdom
+44 0117 928 3473
R&E@ubht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0264192972

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

Changes in oral debris (cleanliness).

Secondary outcome measures

Inter- and intra-examiner variability.

Overall trial start date

01/10/2006

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Approx 80 patients

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

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

United Bristol Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

No publication intended as of 14/06/2011. Published only as a Master's Degree dissertation.

Publication citations

Additional files

Editorial Notes