Phase III trial of articaine hydrochloride with adrenaline bitartrate

JRCT ID: jRCT2061210012

Registered date:15/06/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dental patients
• Date of first enrollment: 06/07/2021
• Target sample size: 86
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: VAS (visual analog scale) during dental procedures after the investigational new drug injection (evaluated by patients)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both
• Include criteria: Patients who are scheduled to undergo extraction of a mandibular wisdom tooth(a half-impacted tooth).

Exclude 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.

Related Information

• Primary Sponsor: Miyawaki Takuya
• Source(s) of Monetary Support: GC SHOWAYAKUHIN CORPORATION