Enhancing Guided Bone Regeneration by Modifying a Resorbable Membrane

Status Recruiting

Clinical Trial Summary

Guided bone regeneration (GBR) procedures have significantly evolved over the last 20 years. Significant advances have been made with various barrier membranes with or without the use of bone grafts and other materials. Some of the main limitations of non-resorbable barriers included cytotoxicity and need for removal, which can adversely affect the regenerated bone volume. Similar GBR success has been documented extensively with cell occlusive resorbable barriers membranes. Recently, the investigators demonstrated supracrestal bone regeneration in guided tissue regeneration procedures in humans with the use of novel perforated barrier membrane (MPM). The perforation allows mesenchymal stem cells and other progenitor cells present in the gingival tissues to migrate into the osseous defect and contribute to the osseous regeneration potential.

The objective of this study is to investigate the GBR potential of MPM in alveolar ridge defects, relative to a similar occlusive barrier. Ten non-smoking patients that need localized alveolar ridge augmentation prior to implant placement will be included into the study. Patients will be divided into two groups, as follows: occlusive bovine collagen membrane (OM control group, 5 patients) and modified bovine perforated collagen membrane (MPM test group, 5 patients). All sites will be grafted with mineralized cortical bone allograft and when needed cortical bone pins will be use for site stability. A Cone Bean (CT) will be obtained prior to surgery and 6-8 months post treatment from which volumetric width changes will be quantify. A bone biopsy will be obtained at the time of implant placement (~6-8 months) to determine residual graft particles and new bone formation. Dimensional width changes will be assess at 6-8 months during re-entry for implant placement. Soft tissue healing will be assessed at 2, 4, 8, 16 weeks and 6 months.

This study can potentially impact current bone augmentation techniques and may lead to the modification of existing commercial membranes that will enhance site development prior to implant placement. The contribution of progenitor cells to the osseous defect might lead to greater bone formation and possible faster wound healing.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Alveolar Ridge Augmentation

Clinical Trial Details

NCT number	NCT02396056
Study type	Interventional
Source	Stony Brook University
Contact	Julio A Carrion, DMD, PhD
Phone	631-632-9443
Email	julio.carrion@stonybrook.edu
Status	Recruiting
Phase	N/A
Start date	December 2014
Completion date	December 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01901783` - Ridge Augmentation Without Primary Closure	N/A
Not yet recruiting	`NCT05014763` - Peri-implant Tissue Stability Following Tissue Augmentation Harvested From Deep Palate or Tuberosity	N/A
Completed	`NCT06206577` - Autogenous Grafts for Anterior Maxillary Horizontal Ridge Augmentation	N/A
Not yet recruiting	`NCT03712631` - Ridge Augmentation in Posterior Mandible Using Tunneling Technique With Amix of Autogenous Bone and Xenograft With and Without Collagen Membrane	N/A
Completed	`NCT03179683` - Effect of Low Level Laser Teraphy on Bone Regeneration	N/A
Completed	`NCT01399775` - Evaluation of Ridge Dimensional Changes After Immediate Implantation and Efficacy of This Procedure	Phase 1/Phase 2
Completed	`NCT03468998` - The Influence of Bone Allograft Particle Sizes on the Quantity and Quality of New Bone Formation in Grafted Extraction Sockets and Edentulous Ridges	N/A
Completed	`NCT03879967` - Lateral Ridge Augmentation Using Allograft Blocks and GBR for Implant Sites	N/A
Recruiting	`NCT04959513` - GBR With L-PRF Bone Block in Early Healing Phase After Extraction	N/A
Active, not recruiting	`NCT06027710` - Allograft Ridge Augmentation: 3D Analysis of CAD/CAM Custom Milled and Prefabricated Conventional Allogeneic Bone Blocks and Dental Implant Follow-up
Not yet recruiting	`NCT05938114` - Comparison of the Use of Natural and Synthetic Bone Substitutes in Dental Implants	N/A
Active, not recruiting	`NCT00520377` - Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation	Phase 2
Completed	`NCT06177899` - A Novel Approach for Horizontal Augmentation: A Split Box
Completed	`NCT06265467` - Evaluation of Two Different Techniques for Sinus Elevation, Open Versus Closed .	N/A
Enrolling by invitation	`NCT05892016` - Ridge Preservation Using Different Techniques	N/A
Completed	`NCT01361321` - Bone Quality and Quantity Following Guided Bone Regeneration	N/A
Suspended	`NCT00299585` - A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation	Phase 2
Completed	`NCT06200077` - Patient Outcomes of Staged Ridge-splitting Using Piezo-electric Surgery in Atrophic Posterior Mandible	N/A
Completed	`NCT05005377` - Peri-Implant Soft and Hard Tissue Stability Following Socket Preservation	N/A
Not yet recruiting	`NCT03592381` - Ridge Expansion by Osseodensification Simultaneously With Implant Placement in Narrow Alveolar Ridges	N/A