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
-
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.