Condition category
Oral Health
Date applied
26/03/2008
Date assigned
09/05/2008
Last edited
28/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

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

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

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20953168

Publication citations

  1. 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.

Additional files

Editorial Notes