NIPH Clinical Trials Search

Autologous 3D-DCob First in Human Study for Alveolar Bone Loss

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Alveolar bone atrophy
Date of first enrollment	09/06/2026
Target sample size	5
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Harvesting of gingival tissue and administration of a specified cell-processed product to the alveolar bone

Outcome(s)

Primary Outcome	Safety: Defined as the incidence of adverse events occurring within 3 weeks after transplantation following gingival tissue harvesting.
Secondary Outcome	Efficacy: 1) Assessed by the rate of alveolar bone formation on CBCT imaging at 24 weeks after transplantation. 2) Histological analysis of bone tissue at 25 weeks after transplantation.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 70age old
Gender	Both
Include criteria	1) Subjects with the loss of one tooth or two or more consecutive teeth who desire prosthetic treatment using dental implants. 2) Patients diagnosed with alveolar ridge atrophy requiring a bone augmentation procedure due to insufficient bone volume for dental implant placement. 3) Subjects who, as pretreatment, have undergone scaling of the remaining adjacent teeth and received toothbrushing instruction, and whose Plaque Control Record (PCR) is 20% or less.
Exclude criteria	1) Patients with a current malignant tumor or a history of malignant tumor within the past 5 years. 2) Patients with a history of drug-induced gingival overgrowth. 3) Patients with poorly controlled respiratory disease or cardiovascular disease. 4) Patients with a smoking history of one or more cigarettes within 1 year prior to obtaining informed consent. 5) Patients with osteoporosis (YAM value <70%, or <80% in those with a history of fragility fracture). 6) Patients with a history of use of medications associated with a risk of medication-related osteonecrosis of the jaw (MRONJ). 7) Patients who test positive on viral screening tests. 8) Patients who are scheduled to undergo surgical treatment at a site adjacent to the investigational site within 48 weeks after transplantation. 9) Patients who participated in another clinical trial/study within 4 weeks prior to enrollment and received administration of an investigational drug, or who are scheduled to participate in another clinical trial during the study period. 10) Patients with metallic restorations in teeth adjacent to the investigational site that may cause artifacts on CBCT images.