Clinical study for guided bone regeneration using novel biodegradable membrane

Phase 1

• Conditions: alveolar bone atrophy; -

• Registration Number: JPRN-jRCTs072190012
• Lead Sponsor: Asahina Izumi

Brief Summary

The study aimed to investigate the safety and feasibility for clinical application of poly (L Lactic acid e caprolactone; P(LA CL)) membrane, a new bioabsorbable synthetic material used for guiding bone regeneration (GBR).The study comprised five subjects with a mean age of 49 years. The application of P(LA CL) membrane for bone augmentation with GBR made it possible to maintain the augmented bone volume without causing any irreversible adverse events.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-01
• Study Completion: 2020-04-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 5

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Efficacy (Reconstruction of alveolar bone tissue)