NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061230003

Registered date:11/04/2023

Study on the efficacy and safety of lidocaine tape application as a surface anesthesia for the mucous membranes of the mouth

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedHealthy volunteers
Date of first enrollment11/04/2023
Target sample size14
Countries of recruitment
Study typeInterventional
Intervention(s)Apply a 1 cm2 lidocaine tape to the oral mucosa for 3 minutes 30G Dental Dentsply Needle to puncture Inject 1.0 mL anesthetic in ORA Injection Dental Cartridge

Outcome(s)

Primary OutcomePain-suppression during infiltration anesthesia needle insertion (Visual Analog Scale)
Secondary OutcomePain-suppressing effect during infiltration anesthetic injection (Visual Analog Scale) Pain-suppression during infiltration anesthetic needle insertion (Verbal Rating Scale) Pain-suppression effect during infiltration anesthetic injection (Verbal Rating Scale)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 60age old
GenderBoth
Include criteria1. Age: 18 years old or older and under 60 years old at the time of obtaining consent. 2. Gender: Any gender 3. Persons who have no inflammation or other abnormal findings in the area to which the study drug will be applied (mucosa of the maxillary lateral incisor in the vestibular region of the oral cavity). 4.Persons who have received a thorough explanation of their participation in this study, and who have given their free and voluntary written consent based on a thorough understanding.
Exclude criteria1. Persons who are judged to lack the ability to make decisions regarding participation in this study. 2. Persons who are allergic or hypersensitive to any of the drugs in this study 3. Persons with drug sensitivity who are allergic to dental Xylocaine cartridges. 4. Pregnant women or women who may be pregnant. 5. Persons with relevance to the department of Oral and Maxillofacial Surgery, Hiroshima University Hospital 6. Any other person who is deemed inappropriate as a research subject by the principal investigator.

Related Information

Contact

Public contact
Name Ryouji Tani
Address 1-2-3 Kasumi, Minami Ward, Hiroshima, 734-8553, JAPAN Hiroshima Japan 734-8553
Telephone +81-82-257-5667
E-mail ryouji@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Souichi Yanamoto
Address 1-2-3 Kasumi, Minami Ward, Hiroshima, 734-8553, JAPAN Hiroshima Japan 734-8553
Telephone +81-82-257-5667
E-mail syana@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital