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 |
| Secondary identifying numbers | 05/Q0906/21 |
- 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
Scientific
School of Dental Sciences
Newcastle University
Newcastle
NE2 4BW
United Kingdom
| Phone | +44 (0)191 222 78 25 |
|---|---|
| j.m.whitworth@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 | |
| 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 | 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 study start date | 27/06/2005 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
School of Dental Sciences
Newcastle
NE2 4BW
United Kingdom
NE2 4BW
United Kingdom
Sponsor information
The Newcastle Upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
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 |
|---|---|
| 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 |
