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

JRCT ID: jRCTs061230003

Registered date:11/04/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteers
• Date of first enrollment: 10/05/2023
• Target sample size: 14
• Study type: Interventional

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 Outcome: Pain-suppression during infiltration anesthesia needle insertion (Visual Analog Scale)

Secondary Outcome

Pain-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
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Yanamoto Souichi