| Source of record | UK Trials |
| ISRCTN | ISRCTN51784460 |
| Date ISRCTN assigned | 11/11/2005 |
| Local reference number(s) | 05/Q0905/12 |
| Public title | The efficacy of different local anaesthetic solutions/techniques in patients suffering 'hot' maxillary tooth pulps |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Irreversible and reversible pulpitis teeth |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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) |
| Patient information material |
|
| Anticipated start date | 28/06/2005 |
| Anticipated end date | 30/06/2007 |
| Status of trial | Completed |
| Target number of participants | 800 |
| Interventions | 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 |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| 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 Gerard Meechan |
| Contact details | Newcastle University
School of Dental Sciences
Framlington Place
Newcastle upon Tyne
United Kingdom
NE2 4BW |
| Contact telephone | +44 (0)191 222 82 92 |
| Contact fax | +44 (0)191 222 61 37 |
| Contact email | j.g.meechan@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN51784460 |
| Date last extracted from ISRCTN register | 17/04/2008 |
