Condition category
Oral Health
Date applied
09/02/2012
Date assigned
11/04/2012
Last edited
20/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr John Meechan

ORCID ID

Contact details

Oral Surgery
School of Dental Sciences
Newcastle University
Framlington Place
Newcastle Upon Tyne
NE2 4BW
United Kingdom

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 measures

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

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

http://www.newcastle-hospitals.org.uk/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23522532

Publication citations

Additional files

Editorial Notes