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

Clinical study on the efficacy and safety of lidocaine tape in surface anesthesia of the oral mucosa in normal subjects

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061230003
Enrollment
14
Registered
2023-04-11
Start date
2023-05-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

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

Sponsors

Yanamoto Souichi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Pain-suppression during infiltration anesthesia needle insertion (Visual Analog Scale)

Secondary

MeasureTime frame
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)

Contacts

Public ContactRyouji Tani

Hiroshima University Hospital

ryouji@hiroshima-u.ac.jp+81-82-257-5667

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026