Development for certificated medical markers using safe pigments in the human body

JRCT ID: jRCTs032230507

Registered date:12/12/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Diseases for which extractions are performed, jaw deformities, jaw bone cysts, jaw bone tumors, oral
• Date of first enrollment: 12/12/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Vivomark is used to draw on the oral mucosa, jawbone, and muscles.

Outcome(s)

Primary Outcome

Writing ability, visibility, and stability of marking on the jawbone and oral mucosa of the research instrument (Vivomark)
Reason for setting: Because the ability to reliably and accurately mark the surgical site is considered an important factor related to the quality and prognosis of surgical procedures, we will evaluate the ease of marking, accuracy, and exudation of the research device on the jawbone and oral mucosa as the main evaluation items.

Secondary Outcome

Evaluate the safety of medical devices based on the following items
1. presence or absence, degree, frequency and extent of allergic reactions at the marking site
2) Effect on wound healing
Presence/absence, degree of persistence, frequency and extent of tattoo scars at the marking site
4. occurrence, frequency, and severity of other serious adverse events and defects

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients undergoing surgery (diseases requiring tooth extraction, jaw deformities, jaw bone cysts, jaw bone tumors, oral mucosa tumors, jaw bone fractures) at the Department of Oral and Maxillofacial Surgery, Center Hospital of National Center for Global Health and Medicine.
2) Adult men and women over 18 years of age
3) Persons who can provide written consent
4) Patients who are able to comply with the protocol and receive medical examinations as specified in this protocol during participation in the study.

Exclude criteria

1) Patients who are deemed inappropriate by the physician in charge.
2) Patients who already have pigmentation on the area to be marked.
3) Patients who may be allergic to the ingredients (ink) of the research equipment (Vivomark), etc.

Related Information

• Primary Sponsor: MARUOKA Yutaka
• Source(s) of Monetary Support: Commons for Medicine and Engineering Japan