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Lamina Soft With Different Collagen Based Materials in Bone Regeneration
Sponsor: Nicola Alberto Valente, DDS, MS, PhD
Summary
This prospective controlled clinical pilot study will compare the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites with buccal bone deficiency, using a collagenated porcine cortical bone lamina as a barrier membrane. A total of 21 patients requiring implant-supported rehabilitation associated with bone regeneration will be enrolled, for a total of 40 implants. In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft, while in the control group a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a semi-rigid collagenated cortical bone lamina will be applied and stabilized to contain the graft material and maintain space for regeneration. The primary objective of the study will be to evaluate volumetric bone changes over time using cone-beam computed tomography imaging, comparing baseline and follow-up scans. Secondary outcomes will include linear measurements of bone gain at different levels around the implant site. The study will investigate whether collagenated xenografts alone can provide comparable clinical and radiographic outcomes to combined grafting approaches including autologous bone, while potentially reducing patient morbidity associated with bone harvesting.
Official title: Use of OsteoBiol® Lamina® Soft and Different Collagen-based Graft Materials in Bone Regeneration: A Pilot Prospective Controlled Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-07-01
Completion Date
2026-01-30
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Guided Bone Regeneration with Implant Placement
Participants will undergo implant placement combined with guided bone regeneration in healed post-extraction sites with buccal bone deficiency. The surgical procedure will include defect debridement, graft placement, and stabilization using a collagenated porcine cortical bone lamina as a semi-rigid barrier membrane fixed with pins. Primary closure will be achieved, and postoperative care will follow standard clinical protocols.
Collagenated Xenogeneic Bone Graft
A collagenated cortico-cancellous xenogeneic bone graft material will be used to fill the bone defect during guided bone regeneration procedures. The material will be applied to promote early vascularization and cellular infiltration, supporting bone regeneration while undergoing physiological remodeling over time.
Hydroxyapatite Xenograft with Autologous Bone
A mixture of hydroxyapatite-based xenogeneic bone graft and autologous bone in a 1:1 ratio will be used to fill the bone defect during guided bone regeneration procedures. The autologous component will provide osteogenic and osteoinductive potential, while the xenograft will contribute to long-term volume stability.
Locations (1)
Università di Cagliari
Cagliari, Cagliari, Italy