Condition category
Oral Health
Date applied
13/09/2005
Date assigned
11/11/2005
Last edited
28/10/2010
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 Martin Whitworth

ORCID ID

Contact details

School of Dental Sciences
Newcastle University
Newcastle
NE2 4BW
United Kingdom
+44 (0)191 222 78 25
j.m.whitworth@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/Q0906/21

Study information

Scientific title

Acronym

Study hypothesis

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

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 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

Phase

Not Specified

Drug names

Primary outcome measures

To evaluate the effectiveness of initial IANB in profoundly anaesthetising irreversibly pulpitic and adjacent non-pulpitic.

Secondary outcome measures

To evaluate the effect of supplementary local anaesthetic techniques after failure of pulp anaesthesia by IANB in patients suffering mandibular irreversible pulpitis.

Overall trial start date

27/06/2005

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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)

Recruitment start date

27/06/2005

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Dental Sciences
Newcastle
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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16554198

Publication citations

  1. Results

    Kanaa MD, Whitworth JM, Corbett IP, Meechan JG, Articaine and lidocaine mandibular buccal infiltration anesthesia: a prospective randomized double-blind cross-over study., J Endod, 2006, 32, 4, 296-298, doi: 10.1016/j.joen.2005.09.016.

Additional files

Editorial Notes