The efficacy of different local anaesthetic solutions/techniques in patients suffering 'hot' maxillary tooth pulps
ISRCTN | ISRCTN51784460 |
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DOI | https://doi.org/10.1186/ISRCTN51784460 |
Secondary identifying numbers | 05/Q0905/12 |
- Submission date
- 13/09/2005
- Registration date
- 11/11/2005
- Last edited
- 05/07/2018
- 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 Gerard Meechan
Scientific
Scientific
Newcastle University
School of Dental Sciences
Framlington Place
Newcastle upon Tyne
NE2 4BW
United Kingdom
Phone | +44 (0)191 222 82 92 |
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j.g.meechan@ncl.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Scientific title | The efficacy of different local anaesthetic solutions/techniques in patients suffering 'hot' maxillary tooth pulps |
Study objectives | 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. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Irreversible and reversible pulpitis teeth |
Intervention | 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 |
Intervention type | Other |
Primary outcome measure | 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 measures | 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. |
Overall study start date | 28/06/2005 |
Completion date | 30/06/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 800 |
Key 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 |
Key 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) |
Date of first enrolment | 28/06/2005 |
Date of final enrolment | 30/06/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle University
Newcastle upon Tyne
NE2 4BW
United Kingdom
NE2 4BW
United Kingdom
Sponsor information
The Newcastle Upon Tyne Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research and Development Department
Room 3.037
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
Phone | +44 (0)191 232 5131 |
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jane.varey@nuth.northy.nhs.uk | |
https://ror.org/05p40t847 |
Funders
Funder type
Government
Student fees
No information available
Support services from NHS
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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 | 01/04/2006 | Yes | No |
Editorial Notes
CV 05/07/2018: Publication reference added.