Clinical Trial

Lamina Soft With Different Collagen Based Materials in Bone Regeneration

Completed
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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.
Trial Details
NCT Number NCT07572643
Lead Sponsor Nicola Alberto Valente, DDS, MS, PhD
Collaborators: Link Campus University, Universita degli Studi di Genova, Saint Camillus International University of Health Sciences
Conditions Alveolar Bone Loss
Enrollment 40 participants
Start Date 2022-07-01
Primary Completion 2026-01-30 (estimated)
Study Completion 2026-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-07