Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBF 99X23
Study information
Scientific title
Acronym
Study hypothesis
Primary research question: does the use of pre-recorded audio tapes encourage patients to complete their course of dental treatment?
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
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Oral health
Intervention
1. Exposure to audio tapes
2. Standard care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The intervention will be considered effective if it reduces the failure rate by 20-40%. To have an 80% power of detecting such a difference as statistically significant at the 5% two-sided level could required 107 children per group (214 in total). This service sees approximately 150 patients per month in this age group. Assuming 60% agree to take part, then to recruit 214 children will take approximately 3 months. The main outcome measure is the difference in the failure rate between the two groups (intervention and control); failures to attend for appointments will be compared by a Chi squared test. 95% confidence intervals for the differences in failures to attend for appointments between the two groups will also be calculated.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/09/1999
Overall trial end date
01/09/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
The age group will be 6-10
Sample size: the main outcome for determining sample size is failure rate. The current failure rate is approximately 60%.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
214
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
27/09/1999
Recruitment end date
01/09/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Community Dental Service
Sheffield
S10 3TH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
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
NHS Executive Trent (UK)
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