Contact information
Type
Scientific
Primary contact
Dr John Whitworth
ORCID ID
Contact details
School of Dental Sciences
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
+44 (0)1912 227825
J.M.Whitworth@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2812 version 1
Study information
Scientific title
Acronym
Study hypothesis
This study will compare the buccal injection alone and combination of buccal and lingual injections in lower front teeth using two local anaesthetic drugs which are routinely used in dentistry (lidocaine and articaine), both with epinephrine.
Study questions:
1. Which of the two methods under investigation most reliably makes lower front teeth numb?
2. How long does numbness last after each injection method?
3. Which injection technique is the most comfortable to receive?
Ethics approval
Newcastle & North Tyneside 1 Research Ethics Committee. Date of approval: 29/06/2004. Substantial amendments approved on 27/05/2005 (ref: 04/Q0905/27)
Study design
Randomised, double-blind, cross-over trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Local anaesthetic methods in anterior mandible
Intervention
This is a randomised, double-blind, cross-over study. Each volunteer will receive 4 local anaesthetic injections in random order in the mouth over 4 visits (one injection per visit). All injections will be given by an experienced dentist.
Injections:
1. 1.8 mL of 2% lidocaine with 1:100,000 epinephrine as a buccal injection
2. 0.9 mL of 2% lidocaine with 1:100,000 epinephrine for both buccal and lingual injections
3. 1.8 mL of 4% articaine with 1:100,000 epinephrine as a buccal injection
4. 0.9 mL of 4% articaine with 1:100,000 epinephrine for both buccal and lingual injections
Intervention type
Drug
Phase
Not Specified
Drug names
Lidocaine, articaine and epinephrine.
Primary outcome measure
Numbness of lower anterior teeth (front teeth) following local anaesthetic injection. This will be assessed by electric pulp testing every 2 minutes after injection for 30 minutes then every 5 minutes until 45 minutes.
Secondary outcome measures
1. Injection discomfort, assessed by a visual analogue scale at each visit
2. Duration of numbness after injection
3. Spreading of anaesthetic solution to adjacent teeth
Overall trial start date
29/10/2007
Overall trial end date
29/10/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy adult volunteers, both men and women
2. Staff or students at the Newcastle University
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
31
Participant exclusion criteria
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
Recruitment start date
29/10/2007
Recruitment end date
29/10/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Dental Sciences
Newcastle upon Tyne
NE2 4BW
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
c/o Ms Amanda Tortice
Research and Developments Office
Fourth floor
Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)1912 825959
Amanda.Tortice@nuth.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Newcastle upon Tyne Hospitals NHS Foundation Trust (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
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20953168
Publication citations
-
Results
Jaber A, Whitworth JM, Corbett IP, Al-Baqshi B, Kanaa MD, Meechan JG, The efficacy of infiltration anaesthesia for adult mandibular incisors: a randomised double-blind cross-over trial comparing articaine and lidocaine buccal and buccal plus lingual infiltrations., Br Dent J, 2010, 209, 9, E16, doi: 10.1038/sj.bdj.2010.974.