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Evaluation of the safety and efficacy of the bio-degradable membrane made of L-lactide/e- caprolactone co-polymers for guided bone regeneration: comparative study with collagen membrane

Comparative study of the safety and efficacy of the bio-degradable membranes for guided bone regeneration

20

Patients with malocclusion and alveolar bone atrophy due to tooth loss who need to have their occlusion reconstructed by dental implants, and who are visiting Nagasaki University Hospital Oral and Maxillofacial Implant Center and Oral and Maxillofacial Surgery Department

Done followed by the protocol.

None.

Group A: T1-T2 of the augmented bone width at 1 mm from the reference line was 0.73 and 0.83 mm in collagen and P(LA/CL) groups. That was 0.78 and 0.49 mm at 3 and 6 mm in P(LA/CL) group. This tendency was same as the collagen group. The absorbable ratios were 30.9 % and 31.8% at 1 mm in collagen and P(LA/CL) groups. Group B: The biggest absorbable rate was found at 1 mm in both collage and P(LA/CL) groups. The augmented bone width was 2.67 and 1.63 mm at T1 and T2, and the absorbable ratio was 45.9% at 1 mm in collagen group. On the other hand, The augmented bone width was 1.87 and 1.44 mm at T1 and T2, and the absorbable ratio was 19.9% at 1 mm in P(LA/CL) group. The absorbable ratio at all points in P(LA/CL) group was lower than that in collagen group even if there was no significant difference. Group C: The bone absorbable ratios were horizontally 44.2 and 43.4% at 1 and 3mm in collagen group. In P(LA/CL) group, those were 29.1 and 18.9 %. The horizontal bone absorbable ratio in P(LA/CL) group showed lower than that in collagen group even if there was no significant difference. The bone height was decreased by 33.5% and 22.0% in collagen and P(LA/CL) groups. There was no significant difference between two group.

The osteogenic potential of GBR with P(LA/CL) was non-inferior to that with collagen.

June. 01, 2023

No

None.

https://jrct.mhlw.go.jp/latest-detail/jRCTs072200063

Seigo Ohba

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

sohba@nagasaki-u.ac.jp

Ohba Seigo

Nagasaki University Hospital

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken

+81-95-819-7704

sohba@nagasaki-u.ac.jp

Complete

Dec. 09, 2020

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Patients who require alveolar ridge augmentation with GBR for oral rehabilitation using dental implants
2. 20 plus and under 90 years old
3. Patients who make written informed consent.

1. Patients who have sever blood diseases
2. Patients who have calcium metabolic diseases, or immune system abnormalities.
3. Patients who are difficult to be followed up
4. .Patients who are restricted to comply the requirements of this study.
5. Smokers
6. Patients who needs the legal representative.
7. Partients who are judged to be inappropriate to participate the study by the principal or cooperative doctors.

Both

Alveolar bone atrophy

Bone biopsy is performed for category 3 subjects

Efficacy: Amount of bone formation evaluated by CT analysis

Safety and Efficacy evaluated by ISQ value of dental implants and histrogical evalusation with bone biopsy

+81-95-819-7229

Oct. 30, 2020

none