None listed
Conditions
Brief summary
The aim of the study is to determine if Articaine was more effective than Lignocaine in achieving local analgesia for dental fillings in the back teeth in the lower jaw among children when using two different techniques of anaesthetic delivery. The null hypothesis is that there is no difference in achieving local analgesia between Articaine 4% and Lignocaine 2%.
Interventions
Comparison of the effectiveness of articaine 4% against lignocaine 2% in obtaining dental local analgesia among children when delivered as a buccal infiltration or inferior alveolar nerve block injections for restorative procedures in mandibular posterior teeth. Dosage of trial anaesthetic limited only to a maximum of 2.2 ml cartridge of the local anaesthetic agent. Dosage of local analgesic agent titrated to maximum of 5 mg/kg body weight. If local analgesia was not achieved with the trial ana
Comparison of the effectiveness of articaine 4% against lignocaine 2% in obtaining dental local analgesia among children when delivered as a buccal infiltration or inferior alveolar nerve block injections for restorative procedures in mandibular posterior teeth. Dosage of trial anaesthetic limited only to a maximum of 2.2 ml cartridge of the local anaesthetic agent. Dosage of local analgesic agent titrated to maximum of 5 mg/kg body weight. If local analgesia was not achieved with the trial anaesthetic patient reappointed for another appointment for the treatment to be completed using standard treatment protocol or supplement with standard local anaesthetic (Lignociane 2%) if the weight of the child allowed supplementation, doseage not to exceed 5mg/kg body weight. Mode of administration, buccal or inferior alveolar block, and type of local anaesthetic used at first visit, test or control, determined by random allocation.
Sponsors
Dental Health Services, Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
Child registered with the School Dental Service in Western Australia. Minimum body weight 20 kg. Require carious bilateral mandibular posterior teeth restored.
Exclusion criteria
There must be no: a. History of allergy to local anaesthetic or any of its constituents. b. Medical conditions contraindicating the use of local analgesia or to undergo dental treatment under local analgesia. c. medications being taken likely to interfere with reporting of pain (analgesics). d. Neurological disorders with sensory disturbances or communication difficulties. e. Non-cooperative behaviour for dental treatment under local analgesia. f. Difficulty with communicating effectively in the English language. g. Possibility of pregnancy. h. Evidence of soft tissue infection/inflammation near site of injection. i. Signs of irreversible pulpal involvement of the study teeth.
Outcome results
None listed