The efficacy of infiltration anaesthesia for adult mandibular incisor teeth

ISRCTN	ISRCTN21993885
DOI	https://doi.org/10.1186/ISRCTN21993885
Secondary identifying numbers	2812 version 1

Submission date: 26/03/2008
Registration date: 09/05/2008
Last edited: 28/03/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John Whitworth
Scientific

School of Dental Sciences
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom

Phone	+44 (0)1912 227825
Email	J.M.Whitworth@ncl.ac.uk

Study information

Study design	Randomised, double-blind, cross-over trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
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
Study objectives	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(s)	Newcastle & North Tyneside 1 Research Ethics Committee. Date of approval: 29/06/2004. Substantial amendments approved on 27/05/2005 (ref: 04/Q0905/27)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lidocaine, articaine and epinephrine.
Primary outcome measure	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 study start date	29/10/2007
Completion date	29/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	31
Key inclusion criteria	1. Healthy adult volunteers, both men and women 2. Staff or students at the Newcastle University
Key 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
Date of first enrolment	29/10/2007
Date of final enrolment	29/10/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Dental Sciences

Newcastle upon Tyne
NE2 4BW
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Ms Amanda Tortice
Research and Developments Office
Fourth floor
Leazes Wing
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
England
United Kingdom

Phone	+44 (0)1912 825959
Email	Amanda.Tortice@nuth.nhs.uk
Website	http://www.newcastle-hospitals.org.uk
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Government

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

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	01/11/2010		Yes	No