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13 May 2008
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| [ Print-friendly version ] |
| The efficacy of infiltration anaesthesia for adult mandibular incisor teeth |
| ISRCTN | ISRCTN21993885 |
| ClinicalTrials.gov identifier | |
| Public title | The efficacy of infiltration anaesthesia for adult mandibular incisor teeth |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | 2812 version 1 |
| Study hypothesis |
This study will compare the buccal injection alone and combination of buccal and lingual injections in lower front teeth using two local anaesthetic drugs which are routinely used in dentistry (lidocaine and articaine), both with epinephrine.
Study questions: 1. Which of the two methods under investigation most reliably makes lower front teeth numb? 2. How long does numbness last after each injection method? 3. Which injection technique is the most comfortable to receive? |
| Ethics approval | Newcastle & North Tyneside 1 Research Ethics Committee. Date of approval: 29/06/2004. Substantial amendments approved on 27/05/2005 (ref: 04/Q0905/27) |
| Study design | Randomised, double-blind, cross-over trial. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Local anaesthetic methods in anterior mandible |
| Participants - inclusion criteria |
1. Healthy adult volunteers, both men and women
2. Staff or students at the Newcastle University |
| Participants - exclusion criteria |
The volunteers:
1. Individuals under 18 years old 2. Systemic disorders which may place volunteers at risk from local anaesthetic injection for example bleeding disorder, history of infective endocarditis, pregnant women 3. Allergies to local anaesthetics. 4. Facial anaesthesia or paraesthesia 5. In dental pain at the time of trial 6. Individuals unable to give informed consent form The teeth: 1. Teeth which respond negatively to baseline pulp testing 2. Key test teeth missing |
| Anticipated start date | 29/10/2007 |
| Anticipated end date | 29/10/2008 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 31 |
| Interventions |
This is a randomised, double-blind, cross-over study. Each volunteer will receive 4 local anaesthetic injections in random order in the mouth over 4 visits (one injection per visit). All injections will be given by an experienced dentist.
Injections: 1. 1.8 mL of 2% lidocaine with 1:100,000 epinephrine as a buccal injection 2. 0.9 mL of 2% lidocaine with 1:100,000 epinephrine for both buccal and lingual injections 3. 1.8 mL of 4% articaine with 1:100,000 epinephrine as a buccal injection 4. 0.9 mL of 4% articaine with 1:100,000 epinephrine for both buccal and lingual injections |
| Primary outcome measure(s) | Numbness of lower anterior teeth (front teeth) following local anaesthetic injection. This will be assessed by electric pulp testing every 2 minutes after injection for 30 minutes then every 5 minutes until 45 minutes. |
| Secondary outcome measure(s) |
1. Injection discomfort, assessed by a visual analogue scale at each visit
2. Duration of numbness after injection 3. Spreading of anaesthetic solution to adjacent teeth |
| Sources of funding | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr John Whitworth |
| Address |
School of Dental Sciences
Newcastle University Framlington Place |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE2 4BW |
| Country | United Kingdom |
| Tel | +44 (0)1912 227825 |
| Fax | +44 (0)1912 226137 |
| J.M.Whitworth@ncl.ac.uk | |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Address |
c/o Ms Amanda Tortice
Research and Developments Office Fourth floor Leazes Wing Royal Victoria Infirmary |
| City/town | Newcastle upon Tyne |
| Zip/Postcode | NE1 4LP |
| Country | United Kingdom |
| Tel | +44 (0)1912 825959 |
| Amanda.Tortice@nuth.nhs.uk | |
| Sponsor website: | http://www.newcastle-hospitals.org.uk |
| Date applied | 26/03/2008 |
| Last edited | 09/05/2008 |
| Date ISRCTN assigned | 09/05/2008 |
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