Clinical study of bone augmentaion using a new bone filler materials.

JRCT ID: jRCT1042240026

Registered date:16/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cases where insufficient bone volume is observed at the implant site during implant treatment
• Date of first enrollment: 16/05/2024
• Target sample size: 17
• Study type: Interventional
• Intervention(s): Patients will be divided into two groups based on the type of bone filling material, and the effects of each bone filling material will be compared between the groups.

Outcome(s)

• Primary Outcome: The rate of implant placement

Secondary Outcome

1) Height of regenerated bone based on panoramic X-ray images and CT images
2) Regenerated bone mass rate based on panoramic X-ray images and CT images
3) CT value and hardness based on CT images
4) Period from transplantation to implant installation
5) Implant survival rate and survival period
6) Histological evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who fall under the following and require bone augmentation (regardless of gender)
1. Patients who are 18 years of age or older and do not have sufficient bone volume at the planned implant site to place a dental implant.
2. Patients who have received oral hygiene instruction (tooth brushing, tartar removal) from a dentist or dental hygienist, and who maintain good plaque control.
3.Patients who have received sufficient explanation about this clinical trial and have given their free written informed consent with full understanding.

Exclude criteria

1. Patients with contraindications to general surgical procedures (severe heart failure, etc.)
2. Patients with poorly controlled diabetes (HbA1c 7% or higher)
3. Patients receiving bone resorption inhibitors (bisphosphonates and denosumab)
4. Patients with or a history of malignant tumor (However, patients with no recurrence or metastasis during 5-year follow-up after primary treatment (excision) may be enrolled)
5. Patients receiving steroids or immunosuppressants (excluding topical administration)
6. Patients with severe collagen disease, bone target hormone metabolic abnormality, immunodeficiency, metabolic disease, endocrine disease, blood disease, and liver disease.
7. Patients with poorly controlled hypertension, arteriosclerosis, cardiovascular disease such as heart failure, or thyroid hyperfunction.
8. Patients with a history of hypersensitivity to dental local anesthetics or their components
9. Patients with dementia or suspected dementia (transmissible spongiform encephalopathy, etc.)
10. Patients with severe psychoneurosis
11. Other patients judged to be ineligible by the study director or study collaborator

Related Information

• Primary Sponsor: Yamada Yoichi