The efficacy of different local anaesthetic solutions/techniques in producing painless sensation in patients suffering 'hot' mandibular tooth pulps

ISRCTN	ISRCTN18143187
DOI	https://doi.org/10.1186/ISRCTN18143187
Protocol serial number	05/Q0906/21
Sponsor	The Newcastle Upon Tyne Hospitals NHS Trust (UK)
Funders	Student fees, Support services from NHS

Submission date: 13/09/2005
Registration date: 11/11/2005
Last edited: 28/10/2010

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 Martin Whitworth
Scientific

School of Dental Sciences
Newcastle University
Newcastle
NE2 4BW
United Kingdom

Phone	+44 (0)191 222 78 25
Email	j.m.whitworth@ncl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The null hypothesis: Supplementary repeat inferior alveolar nerve block (IANB), local infiltration, intraligamentary injection and intraosseous injection after failed IANB are equally effective and pain free in securing anaesthesia for the pulps of irreversibly pulpitic mandibular teeth.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Irreversible pulpitis teeth
Intervention	The power calculation revealed that a sample size using 50 volunteer patients in each supplementary technique (four arms) will have 80% power to detect an effect size of 0.57 in a continuous outcome measure assuming a significance level of 5%. When an initial inferior alveolar nerve block injection (IANB) fails to secure pulp anaesthesia, patients will be randomised to receive one of four supplementary injections (four arms), namely: 1. Repeat IANB with 2% lidocaine with 1:80,000 epinephrine 2. Intraligamentary injection with 2% lidocaine with 1:80,000 epinephrine 3. Intraosseous injection with 2% lidocaine with 1:80,000 epinephrine 4. Local infiltration with 4% articaine with 1:100,000 epinephrine
Intervention type	Other
Primary outcome measure(s)	To evaluate the effectiveness of initial IANB in profoundly anaesthetising irreversibly pulpitic and adjacent non-pulpitic.
Key secondary outcome measure(s)	To evaluate the effect of supplementary local anaesthetic techniques after failure of pulp anaesthesia by IANB in patients suffering mandibular irreversible pulpitis.
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Patients of 16 years of age and over 2. Any mandibular tooth with irreversible pulpitis and an asymptomatic vital tooth on the opposite site of the arch to act as an internal control of pulp tester function
Key exclusion criteria	1. Patients with allergies or sensitivities to lidocaine/articaine or other ingredients in the anaesthetic solution 2. Patients who are unable to provide informed consent 3. Relevant medical history, which may compromise the welfare of the patient (e.g. unstable angina) or which may compromise data collection (e.g. facial paraesthesia)
Date of first enrolment	27/06/2005
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

School of Dental Sciences

Newcastle
NE2 4BW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/04/2006		Yes	No