| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN38542397 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0043189395 |
| Public title | Is photographic evidence a valuable aide to oral hygiene advice in 9-16 year olds? |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Oral Health: Oral hygiene |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 01/12/2006 |
| Anticipated end date | 01/07/2007 |
| Status of trial | Completed |
| 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
Own account
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Zahra Syed |
| Contact details | Upminster Dental Clinic
230 St Mary's Lane
Upminster
Upminster
United Kingdom
RM14 3DH |
| Contact telephone | +44 01708 796786 |
| Contact fax | +44 01708 796150 |
| Contact email | zsyed@nhs.net |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38542397 |
| Date last extracted from ISRCTN register | 17/04/2008 |
