Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
02/05/2012
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

Miss Matina Nikolaou

ORCID ID

Contact details

Paediatric Dentistry
Division of Child Dental Health
The Worsley Building
Clarendon Way
Leeds
LS2 9LU
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes