Condition category
Oral Health
Date applied
13/09/2005
Date assigned
11/11/2005
Last edited
06/08/2007
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 Gerard Meechan

ORCID ID

Contact details

Newcastle University
School of Dental Sciences
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
+44 (0)191 222 82 92
j.g.meechan@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/Q0905/12

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

28/06/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant 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)

Recruitment start date

28/06/2005

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle upon Tyne
NE2 4BW
United Kingdom

Sponsor information

Organisation

The Newcastle Upon Tyne Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
Room 3.037
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 232 5131
jane.varey@nuth.northy.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Student fees

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Support services from NHS

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

Kanaa MD, Whitworth JM, Corbett IP, Meechan JG, Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomised double-blind cross-over study. Journal of Endodontics; In Press.

Publication citations

Additional files

Editorial Notes