|
ISRCTN
|
ISRCTN38542397
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Is photographic evidence a valuable aide to oral hygiene advice in 9-16 year olds?
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0043189395
|
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Oral Health: Oral hygiene
|
|
Participants - inclusion criteria
|
1. Patients with visible plaque (tartar) levels on three or more tooth surfaces (ie 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/12/2006
|
|
Anticipated end date
|
01/07/2007
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Both groups up to 30
|
|
Interventions
|
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, ie is it financially viable to use photos for this purpose in clinics.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Barking and Dagenham Primary Care Trust and Havering Primary Care Trust (UK)
Own account
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Zahra
Syed
|
|
Address
|
Upminster Dental Clinic
230 St Mary's Lane
Upminster
|
|
City/town
|
Upminster
|
|
Zip/Postcode
|
RM14 3DH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01708 796786
|
|
Fax
|
+44 01708 796150
|
|
Email
|
zsyed@nhs.net
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
21/05/2008
|
|
Date ISRCTN assigned
|
28/09/2007
|
