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)

未提供0 个研究点目标入组 6 人开始时间: 待定

适应症

试验速览

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•Patients with malocclusion, determined by the principal or s ub-investigator to require maxillary and mandibular osteotomy for surgical correction.
•Patients who need bone grafting with a maxillary movement of 3 mm or more.
•Aged between 18 and 40 years.
•Patients who provided informed consent voluntarily.

•Patients with sinusitis.
•Patients with concurrent or previous malignant tumors.
•Patients with a history of radiation therapy for malignant tu mors in the oral or surrounding areas.
•Patients with sepsis or suspected sepsis.
•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.
•Patients with severe collagen disease, hormone metabolism abnormalities targeting bones, immunodeficiency, metabolic d isorders, or endocrine disorders.
•Patients with severe mental or neurological disorders.
•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.
•Patients with a history of severe drug allergies.
•Patients who are pregnant, possibly pregnant, or breastfee ding, and are unable to agree to medically appropriate contrac eption during the trial period.
•Other patients deemed unsuitable by the principal or sub-i nvestigator.

发起方

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