NIPH Clinical Trials Search

JRCT ID: jRCT1042240026

Registered date:16/05/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCases where insufficient bone volume is observed at the implant site during implant treatment
Date of first enrollment16/05/2024
Target sample size17
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeThe rate of implant placement
Secondary Outcome1) 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 maximumNot applicable
Include criteriaPatients 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 criteria1. 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


Public contact
Name Wataru Katagiri
Address 1-1, Yanagido, Gifu-city Gifu Japan 501-1194
Telephone +81-58-230-6355
Affiliation Gifu University Graduate School of Medicine
Scientific contact
Name Yoichi Yamada
Address 1-1, Yanagido, Gifu-city Gifu Japan 501-1194
Telephone +81-58-230-6355
Affiliation Gifu University Graduate School of Medicine