臨床研究等提出・公開システム

Date of registration	June. 22, 2026
Last modified on	June. 22, 2026
Trial ID	jRCT2032260235

Scientific Title	Exploratory Study on the Safety of Bone Grafting Using PP620fcg and Autogenous Bone in Patients Undergoing Maxillary and Mandibular Osteotomy for Jaw Deformity (PP620fcg-01)
Public Title	PP620fcg-01 (PP620fcg-01)

Contact for Scientific Queries	Name	Sakamoto Yoshiaki
	Affiliation	Keio University Hospital
	Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
	Telephone	+81-3-3353-1211
	E-mail	prssakamoto@gmail.com
Contact for Public Queries	Name	Tamada Ikkei
	Affiliation	Tokyo Metropolitan Children's Medical Center
	Address	2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
	Telephone	+81-42-300-5111
	E-mail	ikkei_tamada@tmhp.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 12, 2026
Target sample size		6
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with malocclusion, determined by the principal or s ub-investigator to require maxillary and mandibular osteotomy for surgical correction. 2. Patients who need bone grafting with a maxillary movement of 3 mm or more. 3. Aged between 18 and 40 years. 4. Patients who provided informed consent voluntarily.
	Exclusion Criteria	1. Patients with sinusitis. 2. Patients with concurrent or previous malignant tumors. 3. Patients with a history of radiation therapy for malignant tu mors in the oral or surrounding areas. 4. Patients with sepsis or suspected sepsis. 5. Patients with a history of central nervous system, liver, kidn ey, heart, or blood disorders, where the principal or sub-invest igator judges the trial poses safety risks. 6. Patients with severe collagen disease, hormone metabolism abnormalities targeting bones, immunodeficiency, metabolic d isorders, or endocrine disorders. 7. Patients with severe mental or neurological disorders. 8. Patients who have been on bisphosphonates for more than three months prior to consent, or on denosumab for more tha n six months prior to consent, and are unable to discontinue d uring the trial period. 9. Patients with a history of severe drug allergies. 10. Patients who are pregnant, possibly pregnant, or breastfee ding, and are unable to agree to medically appropriate contrac eption during the trial period. 11. Other patients deemed unsuitable by the principal or sub-i nvestigator.
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Jaw Abnormalities
Intervention(s)		A mandibular graft is performed according to the extent of the maxillary bone defect. For bone fragments that cannot be firm ly secured with plates, PP620fcg gel is applied to the grafted bone fragment, which is then placed in the maxillary bone def ect, followed by additional PP620fcg gel applied on top to sec ure the bone.
Health Condition(s) Keyword		Jaw Abnormalities
Health Condition(s) Code		Jaw Abnormalities
Primary Outcome(s)		Safety: 1. Adverse events and malfunctions that cannot be ruled out as causally related to PP620fcg

Primary Sponsor	none

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Keio University Hospital Institutional Review Board for Investigator- Initiated Clinical Trials
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-3353-1211
E-Mail	keio-chiken@adst.keio.ac.jp
Approval Status	Approval
Date of approval	Jan. 22, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None