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ISRCTN
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ISRCTN53304116
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ClinicalTrials.gov identifier
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Public title
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Efficacy of incisive nerve block for pulp anaesthesia in the mandible
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Scientific title
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Acronym
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N/A
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Serial number at source
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4202 version 2
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Study hypothesis
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This study will assess the effect of soft tissue massage on the efficacy and distribution of anaesthesia following incisive nerve block, using 2% lidocaine and 1:80,000 epinephrine. The null hypothesis is that massage of the injection site has no effect on the efficacy and distribution of pulp anaesthesia after incisive nerve block injection.
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Ethics approval
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The Northumberland Research Ethics Committee. Date of approval: 20/11/2007 (ref: 07/H0902/49)
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Study design
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Randomised, double-blind, cross-over trial.
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Anaesthesia in the mandible
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Participants - inclusion criteria
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1. Healthy adult volunteers
2. Staff or students at the Newcastle University
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Participants - exclusion criteria
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The volunteers:
1. Individuals under 18 years old
2. Systemic disorders which may place volunteers at risk from local anaesthetic injection for example bleeding disorder, history of infective endocarditis, pregnant women
3. Allergies to local anaesthetics
4. Facial anaesthesia or paraesthesia
5. In dental pain at the time of trial
6. Individuals unable to give informed consent form
The teeth:
1. Teeth which respond negatively to baseline pulp testing
2. Key test teeth missing
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Anticipated start date
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01/05/2008
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Anticipated end date
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01/01/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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38 volunteers
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Interventions
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This is a randomised, double-blind, cross-over study. Each volunteer will receive 2 incisive nerve block injections in the mouth, one with and one without massage of the injection site, in random order over 2 visits (one injection per visit). All injections will be given by an experienced dentist. The digital massage of the injection site will be done after the injection for 60 seconds.
Incisive nerve block injection: 2% lidocaine + 1:80,000 epinephrine
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Primary outcome measure(s)
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Numbness of lower teeth (back teeth) following local anaesthetic injection. This will be assessed by electric pulp testing every 2 minutes after injection for the first 10 minutes then every 5 minutes until 45 minutes.
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Secondary outcome measure(s)
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1. Injection discomfort, assessed with a visual analogue scale at each visit
2. Duration of numbness after injection
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Sources of funding
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Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
John
Whitworth
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Address
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School of Dental Sciences
Newcastle University
Framlington Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4BW
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Country
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United Kingdom
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Tel
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+44 (0)1912 227825
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Fax
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+44 (0)1912 226137
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Email
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J.M.Whitworth@ncl.ac.uk
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Sponsor
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Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
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Address
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c/o Ms Amanda Tortice
Research and Developments Office
Fourth floor
Leazes Wing
Royal Victoria Infirmary
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE1 4LP
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Country
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United Kingdom
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Tel
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+44 (0)1912 825959
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Email
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Amanda.Tortice@nuth.nhs.uk
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Sponsor website:
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http://www.newcastle-hospitals.org.uk
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Date applied
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26/03/2008
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Last edited
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09/05/2008
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Date ISRCTN assigned
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09/05/2008
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