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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list