Plain English Summary
Background and study aims
In this study we would like determine the mode of action of a local anaesthetic technique used to make the lower molar teeth numb. The local anaesthetic medicine to be used is articaine with adrenaline, a medicine commonly used by dentists.
Who can participate?
Healthy adult volunteers aged 18-30.
What does the study involve?
The volunteers must attend for three visits, at least 1 week apart. At each visit they will receive two injections, one of which will contain the medicine and the other a needle penetration only with no injection of medicine. This is so they cannot guess what anaesthetic treatment they are receiving. No more than 2 ml of medicine will be injected at each visit, which is a typical amount injected during routine dental treatment and is extremely safe. The medicine will be injected into the gum next to three teeth - the canine, first molar and second molar teeth in the lower jaw, using a standard dental syringe. After each needle penetration they will be asked to rate their discomfort. To test how numb each of five teeth in the lower jaw have become they will be tested with an ‘electronic pulp tester’, a standard device for assessing numbness of teeth. Each test will be repeated every 4 minutes for 47 minutes following the injections. We will also test some of their unaffected teeth to make sure the testing device is working properly.
What are the possible benefits and risks of participating?
Some discomfort may be experienced during the injections, the volunteers may find the feeling of numbness unpleasant and they may experience some minor bleeding into their mouth from the injection sites. They should also take care following the injection whilst the numbness is present to avoid any self-inflicted injury. Adverse reactions to the local anaesthetic are very rare but may include headache, swelling or a ‘pins and needles’ sensation once the numbness has worn off, but these are short lived and will resolve without any treatment.
Where is the study run from?
Newcastle Dental Hospital (UK).
When is the study starting and how long is it expected to run for?
February to July 2012.
Who is funding the study?
The study is funded by 3M ESPE.
Who is the main contact?
Dr JG Meechan
john.meechan@newcastle.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A double-blind cross-over trial with healthy adult volunteers comparing molar buccal infiltrations to canine buccal infiltrations for anaesthesia of mandibular teeth
Acronym
Study hypothesis
Mandibular molar infiltrations with articiane have the same mode of action as deposition of local anaesthetic solution at the mental foramen, so therefore a modified mental and incisive nerve block.
Ethics approval
NRES Committee North East - Newcastle and North Tyneside 1, 18/07/2011, ref: 11/NE/0050
Study design
Double-blind placebo-controlled cross-over single-centre study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dental local anaesthesia
Intervention
1.8ml 4% articaine hydrochloride with 1:100000 adrenaline injected in the mucobuccal fold opposite either the lower 1st molar, 2nd molar or canine tooth.
Placebo is needle penetration only.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Response to electronic pulp testing indicating pulpal anaesthesia
Secondary outcome measures
Injection discomfort using a Visual Analogue Scale
Overall trial start date
06/02/2012
Overall trial end date
31/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Volunteers that are aged 18-30 years, with vital molar, first and second premolar, canine and incisor teeth that are not restored.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
22
Participant exclusion criteria
1. Volunteers that are under 18 or over 30 years of age
2. Those unable to give consent
3. Those with self reported bleeding disorders, orofacial anaesthesia or paraesthesia, allergies to local anaesthetic drugs, preganancy at time of study or with teeth that respond negatively to baseline pulp testing or key test teeth missing
Recruitment start date
06/02/2012
Recruitment end date
31/07/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Newcastle Upon Tyne
NE2 4BW
United Kingdom
Sponsor information
Organisation
Newcastle Hospitals NHS Foundation Trust (UK)
Sponsor details
Joint Research Office
Level 6
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
M ESPE (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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23522532