JRCT ID: jRCTs032230078
Registered date:17/05/2023
Development for certificated medical markers using safe pigments for precise marking on surgical field in the human body.
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Diseases requiring tooth extraction, jaw deformity, jawbone cyst, jawbone tumor, oral mucosal tumor, |
Date of first enrollment | 05/01/2023 |
Target sample size | 5 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Draw on the oral mucosa, jawbone, and muscles using a surgical drawer. |
Outcome(s)
Primary Outcome | 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. |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 18age 00month old |
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Age maximum | Not applicable |
Gender | Both |
Include 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 |
Exclude 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) |
Related Information
Primary Sponsor | Maruoka Yutaka |
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Secondary Sponsor | |
Source(s) of Monetary Support | Nippon medical engineering monozukuri commons : Donation |
Secondary ID(s) |
Contact
Public contact | |
Name | Yusuke Takanabe |
Address | 1-21-1, Toyama, Shinjuku-ku, Tokyo. Tokyo Japan 162-8655 |
Telephone | +81-3-3202-71881 |
ytakanabe@hosp.ncgm.go.jp | |
Affiliation | Oral and Maxillofacial Surgery |
Scientific contact | |
Name | Yutaka Maruoka |
Address | 1-21-1, Toyama, Shinjuku-ku, Tokyo. Tokyo Japan 162-8655 |
Telephone | +81-3-3202-7181 |
ymaruoka@hosp.ncgm.go.jp | |
Affiliation | Oral and Maxillofacial Surgery |