The efficacy of infiltration anaesthesia for adult mandibular incisor teeth
| ISRCTN | ISRCTN21993885 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21993885 |
| Protocol serial number | 2812 version 1 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
- Submission date
- 26/03/2008
- Registration date
- 09/05/2008
- Last edited
- 28/03/2012
- 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 Whitworth
Scientific
Scientific
School of Dental Sciences
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
| Phone | +44 (0)1912 227825 |
|---|---|
| J.M.Whitworth@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, cross-over trial. |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Newcastle & North Tyneside 1 Research Ethics Committee. Date of approval: 29/06/2004. Substantial amendments approved on 27/05/2005 (ref: 04/Q0905/27) |
| Health condition(s) or problem(s) studied | Local anaesthetic methods in anterior mandible |
| Intervention | 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 |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lidocaine, articaine and epinephrine. |
| 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. |
| Key secondary outcome measure(s) |
1. Injection discomfort, assessed by a visual analogue scale at each visit |
| Completion date | 29/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 31 |
| Key inclusion criteria | 1. Healthy adult volunteers, both men and women 2. Staff or students at the Newcastle University |
| Key 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 |
| Date of first enrolment | 29/10/2007 |
| Date of final enrolment | 29/10/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
School of Dental Sciences
Newcastle upon Tyne
NE2 4BW
United Kingdom
NE2 4BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/11/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
