Dental disease
Conditions
Interventions
Dental local anesthesia using articaine. Single use of the articaine hydrochloride of the following dose as the infiltration anesthesia or local anesthesia (the combination of infiltration and cond
Sponsors
Okayama University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese patients (outpatients or inpatients) whose age is from 20 to 80 years old 2) Patients who are scheduled to undergo dental treatments (gingival flap resection of single tooth for removing dental caries, scaling of single tooth, periodontal curettage of single tooth, fixing dental cavity at single tooth, tooth preparation for single crown, pulpectomy of single tooth, fixing dental cavities at multiple teeth, teeth preparations for multiple crowns or pulpectomies of multiple teeth) or oral surgery (single tooth extraction with/without the crown division and removal of alveolar bone, multiple teeth extractions with/without crown division and removal of alveolar bone, extraction of half-impacted or impacted tooth) 3) Patients who have written the informed consent about this clinical trial before participating.
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 have received or is receiving the following medicines or treatment which influence to the pain evaluation within 1week. ? Opioid analgesics such as morphine, pentazocine etc. ? Non-steroidal anti-inflammatory drugs such as loxoprofen sodium, aspirin, etc., or antipyretic analgesics such as acetaminophen etc. (exclude the local application) ? Dental procedures 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) VAS during dental procedures after the investigational new drug injection (evaluated by dental practitioners) 2) The category evaluation based on VAS (evaluated by patients and dental practitioners) during dental procedures after the investigational new drug injection.(Category classification: [0.0-1.2, 1.3-2.0 (mild pain), 2.1-7.9, 8.0 (severe pain)-10.0]) 3) VAS during the investigational new drug injection (evaluated by patients) 4) The duration of local anesthesia effect after the investigational new drug injection (evaluated by patients) 5) Accomplishment of dental procedures using the investigational new drug (presence or absence of other local anesthetics using from the start to the end of dental procedures) 6) Dosage amount (total dose, initial dose) 7) Duration of dental procedure 8) VAS during dental procedure which had warranted the additional administration (evaluated by dental practitioners) | — |
Countries
Japan
Contacts
Public ContactTakuya Miyawaki
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Dental Anesthesiology and Special Care Dentistry
Outcome results
None listed