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Trial record 17 of 40 for:    dental regeneration | United States
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Enhancing Guided Bone Regeneration by Modifying a Resorbable Membrane

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ClinicalTrials.gov Identifier: NCT02396056
Recruitment Status : Unknown
Verified October 2016 by Stony Brook University.
Recruitment status was:  Recruiting
First Posted : March 24, 2015
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Stony Brook University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Alveolar Ridge Augmentation Other: BioMend Extend Other: Modified BioMend Extend Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Enhanced Guided Bone Regeneration in Localized Osseous Alveolar Defects by Using a Novel Perforated Resorbable Barrier Membrane
Study Start Date : December 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Occlusive Membrane (OM)
Five patients will be randomly assigned to the OM group.
 Other: BioMend Extend
Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration.
Experimental: Modified Perforated Membrane (MPM)
Five patients will be randomly assigned to the MPM group.
 Other: Modified BioMend Extend
Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration. This membrane will be perforated to allow the passage of cells and growth factors that can potentially enhanced bone augmentation.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical horizontal bone augmentation results through direct measurement. [ Time Frame: at 6 months post treatment ]

Secondary Outcome Measures :
  1. Volumetric measurements with CBCT [ Time Frame: pre- and 6 months post treatment ]

Other Outcome Measures:
  1. De novo bone formation, and residual graft particles quantification with histomorphometric analysis [ Time Frame: at 6 months post treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at the augmentation site, the alveolar ridge must be deficient in a buccolingual dimension (< 5.5 mm): Class 1 Seibert defects.
  • alveolar ridges to be augmented must have a minimum of 4 mm of keratinized gingiva extending the length of the planned augmentation.

Exclusion Criteria:

  • general contraindications to implant surgery
  • subjected to irradiation, chemotherapy or immunosuppressive therapy over the past 5 years
  • poor oral hygiene and motivation
  • uncontrolled diabetes
  • pregnant or lactating
  • substance abusers
  • current smokers
  • psychiatric problems or unrealistic expectations
  • acute infection in the area intended for implant placement
  • positive to HIV and hepatitis B and C
  • affected by autoimmune diseases such as arthritis rheumatoid, systemic lupus erythematosus, sclerodermia, Sjo ̈gren syndrome and dermatomyositis polymyositis
  • treated or under treatment with intravenous amino-bisphosphonates
  • subjected previously to reconstructive procedures of the posterior mandible and
  • under chronic treatment with steroids or non-steroidal anti-inflammatory drugs
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396056


Contacts
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Contact: Julio A Carrion, DMD, PhD 631-632-9443 julio.carrion@stonybrook.edu
Contact: Vincent J Iacono, DMD 631-632-8955 vincent.iacono@stonybrook.edu

Locations
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United States, New York
School of Dental Medicine of Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
Contact: Julio A Carrion, DMD, PhD    631-632-9443    julio.carrion@stonybrook.edu   
Sponsors and Collaborators
Stony Brook University
More Information
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Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT02396056    
Other Study ID Numbers: StonyBrookU
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by Stony Brook University:
Guided Bone Regeneration
Gingival Mesenchymal Stem Cells