The efficacy of different local anaesthetic solutions/techniques in patients suffering 'hot' maxillary tooth pulps

ISRCTN	ISRCTN51784460
DOI	https://doi.org/10.1186/ISRCTN51784460
Secondary identifying numbers	05/Q0905/12

Submission date: 13/09/2005
Registration date: 11/11/2005
Last edited: 05/07/2018

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 Gerard Meechan
Scientific

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

Phone	+44 (0)191 222 82 92
Email	j.g.meechan@ncl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	The efficacy of different local anaesthetic solutions/techniques in patients suffering 'hot' maxillary tooth pulps
Study objectives	The null hypothesis: Pulpal anaesthesia in a maxillary permanent tooth with irreversible pulpitis is no more effective or pain-free following infiltrations of lidocaine or articaine.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Irreversible and reversible pulpitis teeth
Intervention	The power calculation revealed that a sample size using 50 volunteer patients in each supplementary technique (three 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 a buccal infiltration and/or a palatine injection fail to secure pulp anaesthesia, patients will be randomised to receive one of three supplementary injections (three arms) as follows: 1. Repeat infiltration injection 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
Intervention type	Other
Primary outcome measure	To evaluate the efficacy of maxillary infiltration anaesthesia with articaine and lidocaine (both with epinephrine) in patients suffering from irreversible pulpitis in a maxillary permanent tooth.
Secondary outcome measures	To evaluate the efficacy of supplementary injections such as palatine injections, repeat infiltration, intraligamentary, or intraosseous anaesthesia for securing pain control in patients suffering from maxillary irreversible pulpitis tooth.
Overall study start date	28/06/2005
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	800
Key inclusion criteria	1. 16 years of age and over 2. Good medical health 3. Any maxillary 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. Allergies or sensitivities to amide-type local anaesthetics or other ingredients in the anaesthetic solutions 2. Inability 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	28/06/2005
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Newcastle University

Newcastle upon Tyne
NE2 4BW
United Kingdom

Sponsor information

The Newcastle Upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
Room 3.037
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Phone	+44 (0)191 232 5131
Email	jane.varey@nuth.northy.nhs.uk
"ROR"	https://ror.org/05p40t847

Funders

Funder type

Government

Student fees

No information available

Support services from NHS

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	01/04/2006		Yes	No

Editorial Notes

CV 05/07/2018: Publication reference added.