E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
assess if articaine infiltration provides sufficient analgesia for dental treatment without secondary inferior alveoalar nerve blocks |
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E.2.2 | Secondary objectives of the trial |
To assess if infiltration articaine avoids the use of ID blocks in dentistry which can cause nerve injuries |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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 < 16 years and Group B > 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |