Dental patients
Conditions
Interventions
Either articaine hydrochloride and adrenaline bitartrate (3.4 - 5.1 mL) or lidocaine hydrochloride and adrenaline bitartrate (3.6 - 5.4 mL) is injected in the oral cavity.
Sponsors
Miyawaki Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are scheduled to undergo extraction of a mandibular wisdom tooth(a half-impacted tooth).
Exclusion criteria
Exclusion criteria: 1) Extraction of complete impacted wisdom tooth or maxillofacial surgery 2) Patients with the history of allergy to the composition of this investigational new drug, amide type local anesthetic, adrenaline bitartrate or sodium metabisulfite 3) Patients with hypertension whose systolic blood pressure or diastolic blood pressure is over 180 mmHg or 110 mmHg, respectively. 4) Patients with symptom of arteriosclerosis or patients with unstable coronary artery disease. 5) Patients with cardiac failure whose Metabolic Equivalents (MET) are under 4 6) Hyperthyroidism patients with the symptom of it 7) Patients with uncontrolled diabetes mellitus 8) Patients with severe medical diseases (hepatic disorder, renal disorder, cardiovascular diseases, endocrine system diseases, respiratory diseases etc.) or patients with severe psychiatric diseases. 9) Patients in pregnancy or the possibility of pregnancy. Breast-feeding patients. 10) Patients who received another investigational new drug within 12 weeks before this investigational new drug 11) Patients who had received or is receiving medicines or treatments which influence to the pain evaluation within 1 week before screening . 12) Patients with HIV antibody positivity, HBs antigen positivity or HCV antibody positivity. 13) Patients who are determined as inadequacy by the principal investigator or subinvestigater.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS (visual analog scale) during dental procedures after the investigational new drug injection (evaluated by patients) | — |
Contacts
Public ContactMakoto Iwane
Okayama University Hospital
Outcome results
None listed