Study of bone augmentation with biodegradable materials

JRCT ID: jRCTs032240332

Registered date:12/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe alveolar bone atrophy
• Date of first enrollment: 12/09/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): use biodegradable pin

Outcome(s)

• Primary Outcome: efficacy: augmented bone volume according to CBCT images. bone volume was evaluated before, right after, 150 plus/minus 28 days after GBR, and after dental implant placement by CT data.

Secondary Outcome

1. safety; adverse event during the study
2, efficacy: Ncm values of implant placement.
3. efficacy: ISQ value after dental implant placement.
4. efficacy: Histological evaluation with bone biopsy.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients who undergo dental implant treatment and have insufficient alveolar bone volume at the implant placement site and therefore require bone augmentation by GBR prior to implant placement.
2. Age: 20 and older than 20, and younger than 90.
3. Patients who have sufficient explanation about this study and agree to participant in this study by their own decision.

Exclude criteria

1. Patients with severe hematological diseases
2. Patients with abnormalities in kidneys, digestive organs, or other calcium-metabolizing organs, or suspected collagen disease
3. Patients who are not expected to visit the hospital at the decided dates.
4. Patients who are not followed the protocol of this study.
5. Patients who smoke
6. Pregnant or lactating patients
7. Patients who can not show their own decision by themselves.
8. Patients who have illnesses which are listed in data sheet.
9. Patients who are not considered to be suitable to join this study by the researchers.

Related Information

• Primary Sponsor: Seigo Ohba
• Source(s) of Monetary Support: GC Corporation