How do dental injections make your lower teeth go numb?
| ISRCTN | ISRCTN15594715 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15594715 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/02/2012
- Registration date
- 11/04/2012
- Last edited
- 20/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Oral Surgery
School of Dental Sciences
Newcastle University
Framlington Place
Newcastle Upon Tyne
NE2 4BW
United Kingdom
Study information
| Study design | Double-blind placebo-controlled cross-over single-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | NRES Committee North East - Newcastle and North Tyneside 1, 18/07/2011, ref: 11/NE/0050 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Response to electronic pulp testing indicating pulpal anaesthesia |
| Secondary outcome measures | Injection discomfort using a Visual Analogue Scale |
| Overall study start date | 06/02/2012 |
| Completion date | 31/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Both |
| Target number of participants | 22 |
| Key inclusion criteria | Volunteers that are aged 18-30 years, with vital molar, first and second premolar, canine and incisor teeth that are not restored. |
| Key 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 |
| Date of first enrolment | 06/02/2012 |
| Date of final enrolment | 31/07/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4BW
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office
Level 6, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2013 | Yes | No |
