Lamina Soft With Different Collagen Based Materials in Bone Regeneration

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.

Conditions

• Alveolar Bone Loss

Interventions

PROCEDURE

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.

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Link Campus University

  collaborator OTHER

• Universita degli Studi di Genova

  collaborator OTHER

• Saint Camillus International University of Health Sciences

  collaborator OTHER

• Nicola Alberto Valente, DDS, MS, PhD

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2026-01-30

Completion

2026-01-30

Countries

• Italy

Study Locations