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| Efficacy of Anterior Middle Superior Alveolar nerve block (AMSA) versus Infra Orbital Nerve Block (IONB) for dental pulp and soft tissue anaesthesia in the anterior maxilla |
| Source of record | UK Trials |
| ISRCTN | ISRCTN55062915 |
| Date ISRCTN assigned | 22/02/2008 |
| Local reference number(s) | LH- 4327 |
| Public title | Efficacy of Anterior Middle Superior Alveolar nerve block (AMSA) versus Infra Orbital Nerve Block (IONB) for dental pulp and soft tissue anaesthesia in the anterior maxilla |
| Scientific title | |
| Acronym | AMSA vs IONB in anterior maxilla |
| Disease/condition/study domain | Local anaesthetic techniques in anterior maxilla |
| Study hypothesis | 1. Which of the two techniques under investigation most reliably makes upper front teeth numb? 2. How long does numbness last after each injection method? 3. Which injection technique is the most comfortable to receive? |
| Design/methodology | Randomized double-blind cross-over study. |
| Research ethics review | Approved by the Newcastle & North Tyneside 1 Research Ethics Committee on the 13 December 2007 (ref: 07/H0906/140) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Healthy adult volunteers 2. Staff or students at Newcastle University |
| Participants - exclusion criteria | The volunteer: 1. Individuals under 18 years old 2. Systemic disorders which may place volunteers at risk from local anaesthetic injection for example bleeding disorders, history of infective endocarditis, pregnant women 3. Allergies to local anaesthetic drugs 4. Facial anaesthesia or paraesthesia 5. In dental pain at the time of the trial 6. Individuals unable to give informed consent The teeth to be included: 1. Teeth which respond negatively to baseline pulp testing 2. Key test teeth missing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 07/01/2008 |
| Anticipated end date | 07/07/2009 |
| Status of trial | Ongoing |
| Target number of participants | 28 volunteers |
| Interventions | Each participant receives 3 different local anaesthetic injections in the mouth in random order (1 injection per visit, 3 visits in total). Methods of local anaesthetic injections: 1. AMSA: 1 mL of 2% lidocaine with 1:80,000 epinephrine will be given as an AMSA, depositing solution in the palatal mucosa at a point that bisects the maxillary first and second premolars, mid-way between the crest of the gingival margin and the mid palatine suture 2. IONB: 1 mL of 2% lidocaine with 1:80,000 epinephrine will be given as an IONB, inserting the needle at the height of the mucobuccal fold between the first and second maxillary premolars and advancing to the manually-palpated infra-orbital foramen before depositing solution 3. IONB: 2 mL of 2% lidocaine with 1:80,000 epinephrine will be given as an IONB as above |
| Primary outcome measure(s) | Numbness of upper front teeth following local anaesthetic injection, assessed by electric pulp testing at each visit (Average duration of procedure: 1 hour) |
| Secondary outcome measure(s) | 1. Injection discomfort, assessed by visual analogue scales after each visit 2. Duration of numbness after local anaesthetic injection, assessed by a questionnaire to record the duration of lip numbness after each visit/injection |
| Sources of funding | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Sponsor name | Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK) |
| Sponsor details | c/o Ms Amanda Tortice Research and Developments Office 4th floor Leazes Wing Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP |
| Sponsor telephone | +44 (0)191 282 5959 |
| Sponsor fax | +44 (0)191 282 0064 |
| Sponsor email | Amanda.Tortice@nuth.nhs.uk |
| Contact name | Dr John Whitworth |
| Contact details | School of Dental Sciences Framlington Place Newcastle upon Tyne United Kingdom NE2 4BW |
| Contact telephone | +44 (0)191 222 7825 |
| Contact fax | +44 (0)191 222 6137 |
| 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 | ISRCTN55062915 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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