Development for certificated medical markers using safe pigments for precise marking on surgical field in the human body.

Not Applicable

• Conditions: Diseases requiring tooth extraction, jaw deformity, jawbone cyst, jawbone tumor, oral mucosal tumor,

• Registration Number: JPRN-jRCTs032230078
• Lead Sponsor: Maruoka Yutaka

Brief Summary

Minor invasive (marking with pen under development), with intervention, single-center, prospective, open-label, single-arm study (planned number of patients: 5. Expected study end date: March 31, 2023). The observation periods were 1, 4, 8, and 12 weeks postoperatively to investigate wound healing, the presence or absence of tattoo scars, and the occurrence and frequency of serious adverse events. The results showed good penmanship and no adverse events were observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-17
• Study Completion: 2023-05-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1) Patients undergoing surgery (disease requiring tooth extraction, jaw deformity, jawbone cyst, jawbone tumor, oral mucosal tumor, jawbone fracture) at National Center for Global Health and Medicine Hospital Dentistry and Oral Surgery
2) Adult men and women over the age of 18
3) with written consent
4) Subjects who are able to comply with the rules during study participation and receive medical examinations stipulated in this protocol

Exclusion Criteria

1) Patients who are deemed inappropriate by the attending physician.
2) Those who already have pigmentation in the marking area
3) Persons who may be allergic to the ingredients (ink) of the research equipment (surgical drawer)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Writability, visibility and stability of markings on the jawbone and oral mucosa of research instruments (surgical drawers)<br>Reason for setting: Whether or not the surgical site can be marked reliably and accurately is considered to be an important factor related to the quality and prognosis of the surgical operation. Evaluate ease of application, accuracy, and exudability.

Secondary Outcome Measures

Name	Time	Method
Evaluate the safety of medical devices from the following items<br>1. Presence, severity and frequency of allergic reactions at the marking site<br>2. Effect on wound healing<br>3. Presence or absence of tattoo marks at the marking area, degree of remaining, degree of occurrence<br>4. Occurrence and frequency of other serious adverse events and malfunctions