Enhancing Guided Bone Regeneration by Modifying a Resorbable Membrane
Public ClinicalTrials.gov record NCT02396056. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Enhanced Guided Bone Regeneration in Localized Osseous Alveolar Defects by Using a Novel Perforated Resorbable Barrier Membrane
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02396056
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 10 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2014
- Primary completion
- Nov 30, 2017
- Completion
- Nov 30, 2017
- Last update posted
- Oct 16, 2016
2014 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| School of Dental Medicine of Stony Brook University | Stony Brook | New York | 11794 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02396056, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2016 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02396056 live on ClinicalTrials.gov.