Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436165542
Study information
Scientific title
Acronym
Study hypothesis
To find out if there is a difference in pain sensation using conventional dental injection an dental practice and using a computer controlled local anaesthetic device (the Wand computer controlled anaesthetic delivery system).
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
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Signs and Symptoms: Pain
Intervention
Randomised controlled trial
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain sensation measured in mm.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2004
Overall trial end date
01/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. The sample will be drawn from children between 3-10 yrs attending the children's clinic in the department of child dental health, Leeds Dental Institute
2. All children will have no previous dental experience and will be in need of at least one restoration in the maxilla requiring local anaesthesia
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/11/2004
Recruitment end date
01/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Paediatric Dentistry
Leeds
LS2 9LU
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 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
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding (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
1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/19627671
Publication citations
-
Results
Tahmassebi JF, Nikolaou M, Duggal MS, A comparison of pain and anxiety associated with the administration of maxillary local analgesia with Wand and conventional technique., Eur Arch Paediatr Dent, 2009, 10, 2, 77-82.