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Clinical study for guided bone regeneration using novel biodegradable membrane

Clinical study on safety to apply the bio-degradable membrane with L-lactide, E-caprolactone copolymers for guided bone regeneration

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs072190012
Enrollment
5
Registered
2019-07-01
Start date
2019-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alveolar bone atrophy -

Interventions

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

Sponsors

Asahina Izumi
Lead Sponsor
GC Corporation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Safety

Secondary

MeasureTime frame
Efficacy (Reconstruction of alveolar bone tissue)

Contacts

Public ContactYoshinori Sumita

Nagasaki University Hospital

y-sumita@nagasaki-u.ac.jp+81-95-819-7706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026