Clinical study for guided bone regeneration using novel biodegradable membrane

JRCT ID: jRCTs072190012

Registered date:01/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: alveolar bone atrophy
• Date of first enrollment: 01/07/2019
• Target sample size: 5
• Study type: Interventional

Intervention(s)

Intervention period: 160 days
Intervention volume: the size of alveolar bone defect that can be covered by GMEM-B2
Number of times of Intervention: 1 time

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Efficacy (Reconstruction of alveolar bone tissue)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1. Patients who agreed to have dental implant treatment, but whose alveolar bone height and/or width are insufficient for ideal implant placement, and are required the alveolar ridge augmentation with GBR (guided bone regeneration) technique (judge by CT examination one month more before entry).
2. Patients who are diagnosed to be able to obtain the primary fixation when placed the dental implants.
3. Patients who had an alveolar bone height of at least 3mm

Exclude criteria

1. Patients who have severe hematologic disease.
2. Patients who have disorders of organs related to calcium metabolism, such as kidney and digestive organs, and collagen disease.
3. Patients who are getting an artificial dialysis.
4. Patients who are taking steroid medications.
5. Patients who have any cancer, and had got the radiation therapy.
6. Patients who are getting the bisphosphonate treatment.
7. Patients who are limited to obey the requirements of this study by their severe infectious diseases, immune system abnormalities, heart disease and other uncontrollable disorders such as psychological disorder.
8. Patients who are alcohol or drug dependence.
9. Patients who are pregnant and lactation period, or planned pregnancy
10. Patients who live in a remote place and are difficult to visit Nagasaki University Hospital for follow-ups after treatment.
11. Patients who are limited to obey the requirements of this study on the ground of their social or home environment.
12. Patients who are smokers.
13. Patients who need the legal representative.
14. Patients who are judged as improper to join in this study by the principal investigator or co-investigators.

Related Information

• Primary Sponsor: Asahina Izumi
• Secondary Sponsor: GC Corporation
• Secondary ID(s): Nil known