Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
11/06/2014
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

Ms Rosemarie Khan

ORCID ID

Contact details

Community Dental Service
Community Health Sheffield NHS Trust
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom
+44 (0)114 272 8802

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes