NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedDiseases requiring tooth extraction, jaw deformity, jawbone cyst, jawbone tumor, oral mucosal tumor,
Date of first enrollment05/01/2023
Target sample size5
Countries of recruitment
Study typeInterventional
Intervention(s)Draw on the oral mucosa, jawbone, and muscles using a surgical drawer.

Outcome(s)

Primary OutcomeWritability, 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 OutcomeEvaluate 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
Age maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Yusuke Takanabe
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo. Tokyo Japan 162-8655
Telephone +81-3-3202-71881
E-mail 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
E-mail ymaruoka@hosp.ncgm.go.jp
Affiliation Oral and Maxillofacial Surgery