Lamina Soft With Different Collagen Based Materials in Bone Regeneration

NCT07572643 | Completed

• 1 other identifier: Lamina
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Guided Bone Regeneration; Collagenated Xenograft; Autologous Bone; Post-Extraction Socket; Cortical Bone Lamina; Implant Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Volumetric Bone Change

  Change in regenerated bone volume will be assessed using cone-beam computed tomography scans acquired at baseline and follow-up. DICOM datasets will be superimposed and analyzed with dedicated three-dimensional software. Regenerated bone volume will be expressed in cubic millimeters.

  Baseline to 24-36 months after surgery

Secondary Outcomes (3)

• Linear Bone Gain at Implant Neck

  Baseline to 24-36 months after surgery

• Linear Bone Gain 3 mm Apical to Implant Neck

  Baseline to 24-36 months after surgery

• Linear Bone Gain at Implant Apex

  Baseline to 24-36 months after surgery

Study Arms (2)

Collagenated Xenograft + Cortical Lamina

EXPERIMENTAL

Participants in this arm will undergo horizontal bone regeneration using a collagenated cortico-cancellous xenogeneic graft material. The graft will be placed in healed post-extraction sites presenting buccal bone deficiency. A collagenated porcine cortical bone lamina will be used as a semi-rigid barrier membrane and stabilized with fixation pins to contain the graft and maintain space for bone regeneration. Implant placement will be performed in conjunction with the regenerative procedure.

Procedure: Guided Bone Regeneration with Implant Placement; Procedure: Collagenated Xenogeneic Bone Graft

Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina

ACTIVE COMPARATOR

Participants in this arm will undergo horizontal bone regeneration using a mixture of hydroxyapatite-based xenogeneic graft material and autologous bone in a 1:1 ratio. The graft will be placed in healed post-extraction sites with buccal bone deficiency. A collagenated porcine cortical bone lamina will be used as a semi-rigid barrier membrane and stabilized with fixation pins to ensure graft containment and space maintenance. Implant placement will be performed in conjunction with the regenerative procedure.

Procedure: Guided Bone Regeneration with Implant Placement; Procedure: Hydroxyapatite Xenograft with Autologous Bone

Interventions

Guided Bone Regeneration with Implant Placement PROCEDURE

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 Xenograft + Cortical Lamina; Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina

Collagenated Xenogeneic Bone Graft PROCEDURE

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.

Collagenated Xenograft + Cortical Lamina

Hydroxyapatite Xenograft with Autologous Bone PROCEDURE

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.

Hydroxyapatite Xenograft + Autologous Bone + Cortical Lamina

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healed type II post-extraction sockets according to the Elian classification
• Age between 18 and 80 years
• Good periodontal control, defined as treated periodontitis with plaque index \<25% and bleeding on probing \<25%
• ASA I or ASA II systemic status
• Ability and willingness to provide written informed consent
• Ability and willingness to attend scheduled follow-up visits

You may not qualify if:

• Smoking more than 10 cigarettes per day
• Active oral infections
• Mucosal diseases, including erosive lichen planus
• History of radiotherapy in the head and neck region
• Systemic diseases affecting bone metabolism or contraindicating oral surgery
• Non-compliance or inability to complete follow-up
• Extraction sockets with intact bone walls

Sponsors & Collaborators

• Nicola Alberto Valente, DDS, MS, PhD: lead
• Link Campus University: collaborator
• Universita degli Studi di Genova: collaborator
• Saint Camillus International University of Health Sciences: collaborator

Study Sites (1)

Università di Cagliari

Cagliari, Cagliari, 09125, Italy

Location

Related Publications (4)

• Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.

  PMID: 36345818 BACKGROUND

• Barone A, Toti P, Menchini-Fabris GB, Derchi G, Marconcini S, Covani U. Extra oral digital scanning and imaging superimposition for volume analysis of bone remodeling after tooth extraction with and without 2 types of particulate porcine mineral insertion: A randomized controlled trial. Clin Implant Dent Relat Res. 2017 Aug;19(4):750-759. doi: 10.1111/cid.12495. Epub 2017 May 16.

  PMID: 28508515 BACKGROUND

• Calciolari E, Corbella S, Gkranias N, Vigano M, Sculean A, Donos N. Efficacy of biomaterials for lateral bone augmentation performed with guided bone regeneration. A network meta-analysis. Periodontol 2000. 2023 Oct;93(1):77-106. doi: 10.1111/prd.12531. Epub 2023 Sep 27.

  PMID: 37752820 BACKGROUND

• Susin C, Wikesjo UM. Regenerative periodontal therapy: 30 years of lessons learned and unlearned. Periodontol 2000. 2013 Jun;62(1):232-42. doi: 10.1111/prd.12003.

  PMID: 23574469 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be allocated to one of two parallel groups based on the chronological order of enrollment. The test group will receive bone regeneration using a collagenated cortico-cancellous sticky xenograft, while the control group will receive a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio. In both groups, a collagenated porcine cortical bone lamina will be used as a barrier membrane. The study will compare radiographic and clinical outcomes between the two groups.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: July 1, 2022
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months following publication of the primary results and will remain available for up to 5 years.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be granted to researchers who provide a methodologically sound research proposal. Requests will be reviewed by the study investigators. Data will be shared after approval of a data access agreement and in compliance with institutional policies and applicable data protection regulations. Data will be made available upon reasonable request to the corresponding author.

Locations

IT (1)