| Source of record | UK Trials |
| ISRCTN | ISRCTN18143187 |
| Date ISRCTN assigned | 11/11/2005 |
| Local reference number(s) | 05/Q0906/21 |
| Public title | The efficacy of different local anaesthetic solutions/techniques in producing painless sensation in patients suffering 'hot' mandibular tooth pulps |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Irreversible pulpitis teeth |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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) |
| Patient information material |
|
| Anticipated start date | 27/06/2005 |
| Anticipated end date | 30/06/2007 |
| Status of trial | Completed |
| Target number of participants | 500 |
| Interventions | 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 |
| Primary outcome measure(s) | To evaluate the effectiveness of initial IANB in profoundly anaesthetising irreversibly pulpitic and adjacent non-pulpitic. |
| Secondary outcome measure(s) | To evaluate the effect of supplementary local anaesthetic techniques after failure of pulp anaesthesia by IANB in patients suffering mandibular irreversible pulpitis. |
| Publications | 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. |
| Sources of funding | 1. Student fees
2. Support services from NHS |
| Sponsor name | 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
United Kingdom
NE1 4LP |
| Sponsor telephone | +44 (0)191 232 5131 |
| Sponsor fax | +44 (0)191 201 0155 |
| Sponsor email | jane.varey@nuth.northy.nhs.uk |
| Contact name | Dr John Martin Whitworth |
| Contact details | School of Dental Sciences
Newcastle University
Newcastle
United Kingdom
NE2 4BW |
| Contact telephone | +44 (0)191 222 78 25 |
| Contact fax | +44 (0)191 222 61 37 |
| Contact email | j.m.whitworth@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN18143187 |
| Date last extracted from ISRCTN register | 17/04/2008 |
