Alveolar Ridge AugmentationNCT02396056
Enhancing Guided Bone Regeneration by Modifying a Resorbable Membrane
A study testing BioMend Extend and Modified BioMend Extend in people with Alveolar Ridge Augmentation, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- BioMend Extend and Modified BioMend Extend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
School of Dental Medicine of Stony Brook University
Stony Brook, New York, 11794
Julio A Carrion, DMD, PhD, 631-632-9443, julio.carrion@stonybrook.edu
About this study
Official title: Enhanced Guided Bone Regeneration in Localized Osseous Alveolar Defects by Using a Novel Perforated Resorbable Barrier Membrane
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.
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- BioMend Extend, Modified BioMend Extend
- Keywords
- Guided Bone Regeneration, Gingival Mesenchymal Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMend ExtendOther
Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration.
Modified BioMend ExtendOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Occlusive Membrane (OM) | Sham comparator | Five patients will be randomly assigned to the OM group. Receives: Other: BioMend Extend |
| Modified Perforated Membrane (MPM) | Experimental | Five patients will be randomly assigned to the MPM group. Receives: Other: Modified BioMend Extend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical horizontal bone augmentation results through direct measurement.
Measured: at 6 months post treatment
Secondary outcomes (1)
Volumetric measurements with CBCT
Measured: pre- and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396056
- Sponsor's protocol ID
- StonyBrookU
- Status last verified
- Oct 2016
- First submitted
- 18 Mar 2015
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Guided Bone Regeneration in Localized Osseous Alveolar Defects by Using a Novel Perforated Resorbable Barrier Membrane
- ClinicalTrials.gov ID
- NCT02396056
- Acronym / sponsor ID
- StonyBrookU
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- Guided Bone Regeneration, Gingival Mesenchymal Stem Cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusive Membrane (OM) | Sham comparator | Other: BioMend ExtendFive patients will be randomly assigned to the OM group. |
| Modified Perforated Membrane (MPM) | Experimental | Other: Modified BioMend ExtendFive patients will be randomly assigned to the MPM group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMend ExtendBiomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration. | Other | Occlusive Membrane (OM) |
| Modified BioMend ExtendBiomend 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. | Other | Modified Perforated Membrane (MPM) |
Primary outcome
Clinical horizontal bone augmentation results through direct measurement.
Time frame: at 6 months post treatment
1 secondary outcome
Volumetric measurements with CBCT
Time frame: pre- and 6 months post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioMend Extend and Modified BioMend Extend in people with Alveolar Ridge Augmentation, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julio A Carrion, DMD, PhD (631-632-9443, julio.carrion@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical horizontal bone augmentation results through direct measurement. (time frame: at 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.