Condition category
Oral Health
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
15/10/2014
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

Dr Zahra Syed

ORCID ID

Contact details

Upminster Dental Clinic
230 St Mary's Lane
Upminster
Upminster
RM14 3DH
United Kingdom
+44 01708 796786

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0043189395

Study information

Scientific title

Acronym

Study hypothesis

To find out whether giving patients photographic evidence of their own poor oral hygiene/appearance of teeth when they smile motivates 9-16 year olds to improve their tooth brushing and oral health behaviour.

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

Other

Trial type

Prevention

Patient information sheet

Condition

Oral Health: Oral hygiene

Intervention

A randomised controlled trial with two study groups:
1. Group 1: standard intervention (control) including manual toothbrush and standardised oral and written tooth brushing instruction based on the bass technique
2. Group 2: as with standard intervention with the addition of standardised photographic evidence of the subjects oral health status and instructions how best to use this.

All paperwork to be used by subjects reviewed by focus group through PPI for B&D service.

Procedure:
1. Define whether patient fits inclusion criteria
2. Gain written photographic consent for inclusion in trial
3. Assign to group 1 or 2 in random fashion
4. Initial appointment: initial questionnaire (demographic data, i.e. age, sex, is appearance important to you, etc.); measure modified plaque and bleeding indices (how much tartar and bleeding from teeth and gums). If assigned to group 2 take initial standard set of photos and give set plus instructions (to put them on bathroom mirror) to subject. If group 1 a single photograph of anterior view showing incisors, to both groups give written oral hygiene instructions.
5. Review at 6 weeks - measure plaque and bleeding indices and take new set of photos appropriate to group, and if group 2 give set to patient
6. Review at 12 weeks - measure plaque and bleeding indices and take final photos and give final questionnaire (how did they use the information given, what was most helpful)

Analysis:
1. For each subject analyse any changes in plaque and bleeding scores and for group 2 compare the standardised initial and review photos for both groups by measuring the change in gingival height from a fixed point on the lower central incisors (i.e., has there been any reduction in swelling to the gums) to give an accurate measure of actional improvements (rather than the kids just brushing hard before coming to the clinic) in oral hygiene. This latter measure will give significance to the results.
2. Maintain record of photographic costs and find information for similar volumes using alternatives, e.g. digital photography, i.e. is it financially viable to use photos for this purpose in clinics.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2006

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with visible plaque (tartar) levels on three or more tooth surfaces (i.e., a minimum plaque score of 3)
2. Attending Barking and Dagenham Special Needs and Community Dental Service
3. Aged between 9 - 16 years
4. Who have the ability to brush their own teeth unsupervised
5. Have no conditions that would contraindicate measuring the bleeding from the gums

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Both groups up to 30

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/12/2006

Recruitment end date

01/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Upminster Dental Clinic
Upminster
RM14 3DH
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

Barking and Dagenham Primary Care Trust and Havering Primary Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

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

Publication citations

Additional files

Editorial Notes