OU-BMP-IP-1/2

JRCT ID: jRCT2061210032

Registered date:27/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alveolar bone defect
• Date of first enrollment: 24/08/2021
• Target sample size: 8
• Study type: Interventional
• Intervention(s): Application of OIF/KXd on the site requiring bone augmentation before implantation of a dental implant.

Outcome(s)

• Primary Outcome: The adverse events occurred within four weeks from applying this investigational product until the installation of the upper structure of the dental implant and the adverse effects associated with instruments employed to apply this investigational product.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1)Patients within 25-75 years old, at the time the informed consent was obtained. Female patients should be in menopause.
2)Patients willing to receive dental implant treatment but have insufficient alveolar bone support, i.e., the vertical/horizontal bone regeneration with autologous bone is thought to be necessary for the successful dental implant surgery after comprehensively evaluating the patients' condition.
3)All patients should only have one implantation site required for the bone augmentation during this clinical trial.
4)Patients after completed periodontal treatment, if necessary.
5)Patients with the plaque control record less than 20%.
6)Patients with general conditions that are suitable for surgery and whose eligibility is confirmed using the above inclusion criteria by the principal investigator and other participated researchers.

Exclude criteria

1)The target site of bone augmentation has mucosa hypertrophy or oro-nasal communication due to previous otolaryngological treatment.
2)Patients with confirmed osteoporosis.
3)Patients with malignant tumors or a clinical history of malignant tumors and recurrence-free years are less than 5.
4)Patients with diabetes and whose blood sugar is evaluated as uncontrollable by a qualified medical doctor.
5)Patients who have hypertension and whose blood pressure is evaluated as uncontrollable by a qualified medical doctor.
6)Patients with unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, or transient ischemic attack within three months.
7)Patients with hepatic or renal dysfunctions, or severe complications related to cardiac diseases.
8)Patients with allergic history to some drugs, metals, food, and chemicals
9)Patients who are currently smoking.

Related Information

• Primary Sponsor: Kuboki Takuo
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development