necessary dental surgery
Conditions
Interventions
Trade Name: Articaine
Lignocaine
Product Name: lidocaine and carticaine
Product Code: lignocaine and articaine
Pharmaceutical Form: Solu
Sponsors
Kings College Hospital Trust R&D
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) English as preferred language and full understanding of invitation to participate. 2) Patients whom are being booked for routine dental procedures (extraction, periodontal treatment, restoration of crown, root canal treatment) of teeth at the KCL Dental Institute. 3) Patients will have no known contraindications to Lignocaine or Articaine local analgesia. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Patients who are too anxious to undergo treatment under local anaesthetic alone. 2) Patients who have a known allergy to local analgesic agents. 3) Patients who have an acute infection prohibiting application of an inferior alveolar nerve block injection. The study is designed to adhere to the SPC specified contra-indications to Articaine and Lignocaine. These include: Articaine-specific: Patients under 4 years of age; Patients too anxious to undergo treatment under local anaesthetic alone; Patients who have an acute infection prohibiting application of an inferior alveolar nerve block injection; Hypersensitivity to any local anaesthetic agent; Hypersensitivity to any other component of SEPTANEST (trading name for Articaine); Patients who have experienced bronchospasm after administration of any product which contains sulphites; Patients who are known, or who have a history which suggests a deficiency in plasma cholinesterase activity; Patients receiving monoamine oxidase inhibitors (or who have received such an agent within two weeks) or tricyclic antidepressants; Patients in whom there is a possibility that general anaesthesia might be required to complete the procedure; Patients with a deficiency of plasma cholinesterase activity; Patients with severe hepatic disease; Patients with diabetes; Patients with thyrotoxicosis. Patients with cardiovascular disease, abnormalities of cardiac conduction, or a history of epilepsy. Lignocaine-specific: Hypersensitivity to anaesthetics of the amide type or the other constituents. Patients with epilepsy, impaired cardiac conduction, impaired respiratory function, and in patients with impaired hepatic function, if the dose or site of administration is likely to result in high blood levels; Patients with hypertension, cardiac disease, cerebrovascular insufficiency or thyrotoxicosis; Patients taking tricyclic antidepressants, monoamine oxidase inhibitors or receiving potent general anaesthetic agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: assess if articaine infiltration provides sufficient analgesia for dental treatment without secondary inferior alveoalar nerve blocks;Secondary Objective: To assess if infiltration articaine avoids the use of ID blocks in dentistry which can cause nerve injuries; Primary end point(s): To assess whether the application of a rescue inferior alveolar block (Lignocaine) is necessary to complete the dental procedure for infiltration only Articaine procedures compared with gold standard Lignocaine infiltration and block. The study is a prospective 2 armed randomised double-blinded clinical trial. Patients will receive either Articaine or Lignocaine 2x 2ml infiltration for dental treatment by an independent practitioner, after randomisation into 2 LA arms either Lignocaine or Articaine. This will require numbers tables. The surgical operator and patient will be blinded to analgesic agent. In summary they are 2 x age groups of patients (Group A 16years): Secondary variables for Group A 1. tooth groups deciduous incisors/canines permanent incisors/canines deciduous molars permanent premolars permanent molars g=5 2. treatment groups restoration extraction t=2 Secondary variables for Group B 1. tooth groups permanent incisors/canine permanent premolars permanent molars third molars g=4 2. treatment groups restoration extraction peridontal t=3 | — |
Countries
United Kingdom
Outcome results
None listed