Condition category
Oral Health
Date applied
26/03/2008
Date assigned
09/05/2008
Last edited
20/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is not much published evidence on the effectiveness of the incisive/mental nerve block (IMNB) for anaesthesia of lower premolar and incisor teeth. Anecdotal reports have suggested that soft tissue massage over the area of injection may help local anaesthetic to move into the lower jaw and improve the effectiveness of the injection. This has never been tested in a clinical trial.
The aim of this study was to assess the effect of soft tissue massage on the effectiveness and distribution of anaesthesia following IMNB. In addition, the speed of onset of anaesthesia and the discomfort associated with IMNB and soft tissue massage were investigated.

Who can participate?
Healthy adults were recruited to the study.

What does the study involve?
Participants attended on two occasions, at least 1 week apart, and received an IMNB injection on each occasion. One of the injections was followed by manual massage of the soft tissues over the place of injection, the other being followed by ‘dummy’ massage on the adjacent teeth. The order of real or dummy massage was determined randomly. Participants were asked to report how much discomfort was associated with the injection and following massage. During the next 45 minutes, teeth were tested with an electronic pulp tester to assess whether their nerves had feeling.

What are the possible benefits and risks of participating?
Benefits include contributing to the body of knowledge on dental local anaesthesia and helping to improve the comfort and care of dental patients in the future. Risks include slight bruising and discomfort at the site of injection, accidental damage to lips and gums when they are numb and unexpected adverse reactions to local anaesthetic agents.

Where is the study run from?
Newcastle Dental Hospital, Newcastle Hospitals NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
The study started in May 2008 and ran January 2009.

Who is funding the study?
Newcastle University (UK).

Who is the main contact?
Dr John Whitworth
john.whitworth@newcastle.ac.uk

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

4202 version 2

Study information

Scientific title

Acronym

Study hypothesis

This study will assess the effect of soft tissue massage on the efficacy and distribution of anaesthesia following incisive nerve block, using 2% lidocaine and 1:80,000 epinephrine. The null hypothesis is that massage of the injection site has no effect on the efficacy and distribution of pulp anaesthesia after incisive nerve block injection.

Ethics approval

The Northumberland Research Ethics Committee. Date of approval: 20/11/2007 (ref: 07/H0902/49)

Study design

Randomised, double-blind, cross-over trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anaesthesia in the mandible

Intervention

This is a randomised, double-blind, cross-over study. Each volunteer will receive 2 incisive nerve block injections in the mouth, one with and one without massage of the injection site, in random order over 2 visits (one injection per visit). All injections will be given by an experienced dentist. The digital massage of the injection site will be done after the injection for 60 seconds.

Incisive nerve block injection: 2% lidocaine + 1:80,000 epinephrine

Intervention type

Drug

Phase

Not Specified

Drug names

Lidocaine and epinephrine

Primary outcome measures

Numbness of lower teeth (back teeth) following local anaesthetic injection. This will be assessed by electric pulp testing every 2 minutes after injection for the first 10 minutes then every 5 minutes until 45 minutes.

Secondary outcome measures

1. Injection discomfort, assessed with a visual analogue scale at each visit
2. Duration of numbness after injection

Overall trial start date

01/05/2008

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy adult volunteers
2. Staff or students at the Newcastle University

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

38 volunteers

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

01/05/2008

Recruitment end date

01/01/2009

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23506279

Publication citations

  1. Results

    Jaber A, Whitworth JM, Corbett IP, Al-Baqshi B, Jauhar S, Meechan JG, Effect of massage on the efficacy of the mental and incisive nerve block., Anesth Prog, 2013, 60, 1, 15-20, doi: 10.2344/12-00024.1.

Additional files

Editorial Notes