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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230078
Enrollment
5
Registered
2023-05-17
Start date
2023-01-05
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

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

Interventions

Draw on the oral mucosa, jawbone, and muscles using a surgical drawer.

Sponsors

Maruoka Yutaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Writability, visibility and stability of markings on the jawbone and oral mucosa of research instruments (surgical drawers) 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

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

Contacts

Public ContactYusuke Takanabe

Oral and Maxillofacial Surgery

ytakanabe@hosp.ncgm.go.jp+81-3-3202-71881

Outcome results

None listed

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