Study of the effectiveness of microneedle patches

JRCT ID: jRCTs072240080

Registered date:27/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Periodontal disease
• Date of first enrollment: 27/11/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Dental surface anesthesia using Anespatch or Anespatch no needle before local anesthesia

Outcome(s)

• Primary Outcome: Degree of pain during local anesthesia(VAS)

Secondary Outcome

1.Depth of surface anesthesia
2.Blood pressure, pulse rate, and transcutaneous oxygen saturation before and after patch application at 5-minute intervals
3.Discomfort caused by the Anes patch

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1.Patients who visited the dental department of Nagasaki University Hospital and were diagnosed as needing SRP under infiltration anesthesia for periodontal disease in the maxillary premolar area on both sides
2.Patients with remaining maxillary premolars on both sides
3.Age: Adult patients aged 18 to 85 years at the time of obtaining consent
4.Any gender
5.Inpatient/outpatient: Outpatient only
6.Patients who have received a sufficient explanation of their participation in this study, fully understood the study, and voluntarily provided written consent

Exclude criteria

1.Patients who regularly use analgesics
2.Patients with a history of hypersensitivity to benzoate ester-based local anesthetics
3.Patients with methemoglobinemia
4.Pregnant and breastfeeding women
5.Patients who the principal investigator deems inappropriate to be study subjects

Related Information

• Primary Sponsor: Kiriishi Kensuke
• Source(s) of Monetary Support: CosMED Pharmaceutical Co., Ltd.