Alveolar Bone LossRidge MeshNCT00991432
Localized Alveolar Ridge Augmentation With Space Maintenance Devices
An observational study of Alveolar Bone Loss, run by Medtronic Spinal and Biologics at 8 sites in United States.
Trial summary
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- INFUSE® Bone Graft
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 8 sitesUnited States
- Study dates
- Oct 2009to Mar 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients needing bone augmentation of the alveolar ridge
Who may be able to join
- Able to provide written informed consent
- ≥ 18 years
- Scheduled for dental implant into anterior maxillary alveolar ridge
- Negative urine pregnancy test for patients of child bearing potential and agreement not to become pregnant for at least 12 months after surgery
- Able to comply with all study-related procedures, including exercising good oral hygiene
- A prosthodontic treatment plan has been drafted.
Who cannot join
- Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
- Known hypersensitivity to titanium
- Operative site is in the area of a resected or extant tumor
- Any active malignancy or current treatment for a malignancy
- Active infection at operative site
- History of prior exposure to rhBMP-2/ACS
Show all 18Show fewer
- Received and failed a previous alveolar ridge augmentation procedure
- Pathology that would either compromise a bone grafting procedure, or interfere with obtaining quantitative measurements from postoperative computer tomography scans
- Significant untreated periodontal disease (> Grade III), caries, or chronic inflammation of the oral cavity at operative site
- Active use of any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc.
- Insulin-dependent diabetic, or has known glycated hemoglobin (HgbA1c) levels >6.5 %
- History of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin
- Patients who are lactating
- History of metabolic bone disease, excluding idiopathic osteoporosis
- History of autoimmune disease (e.g., documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g., human immunodeficiency virus or acquired immunodeficiency syndrome)
- History of immune deficiency due to other treatments (e.g., radiation therapy, chemotherapy, steroid therapy)
- History of adverse reaction to prior exposure to silicone or injectable collagen
- Treatment with an investigational therapy within 1 month before the surgical procedure or plans to be treated with an investigational therapy during the study period.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Study site
Chicago, Illinois, 60611
Study site
Denver, North Carolina, 28037
Study site
Greenwood Village, Colorado, 80111
Study site
Lafayette, Indiana, 47904
Study site
Los Angeles, California, 90049
Study site
Los Angeles, California, 90095
Study site
Portland, Oregon, 97221
Study site
Sarasota, Florida, 34237
About this study
Official title: An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Space Maintenance Devices for Soft Tissue Management
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant, so that a dental implant can later be inserted.
Read the detailed description
The INFUSE® Bone Graft is a device approved by the FDA to be used instead of using your own bone (from another site on your body) to replace missing bone in your jaw. INFUSE® Bone Graft is commercially available and is made up of 2 parts - recombinant human Bone Morphogenetic Protein-2 (rhBMP 2) placed on an absorbable collagen sponge (ACS). The rhBMP-2 is a genetically altered protein which recruits bone-forming cells to the surgical area and changes local cells to bone. ACS is made from Type I collagen from bovine (cattle) tendon. It helps to hold the rhBMP-2 in place and acts as a support for the growing bone. The sponge itself will reabsorb in time as the new bone forms.
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw so that a dental implant can later be inserted. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with space holding devices, in a 2-part procedure. Your dental implants will be placed at approximately 6 months after the INFUSE® Bone Graft implant.
- Conditions
- Alveolar Bone Loss
- Being tested
- INFUSE® Bone Graft
- Keywords
- Alveolar Ridge Augmentation, Dental Implantation, Endosseous, Osseointegration, Space Maintenance, Bone Morphogenetic Proteins
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFUSE® Bone GraftDevice
Patients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS concurrent with space maintenance devices for soft tissue management on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® Bone Graft material, or as regularly scheduled as per the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments approximately 6 months after surgery. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility.
| Study group | Role | What they receive |
|---|---|---|
| INFUSE® Bone Graft | all study participants will receive INFUSE® Bone Graft Receives: Device: INFUSE® Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge bone formation sufficient to place endosseous implants
Measured: approximately 6 months post-surgery
Secondary outcomes (1)
Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans.
Measured: approximately 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Averion International Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991432
- Sponsor's protocol ID
- P09-04
- Acronym
- Ridge Mesh
- Status last verified
- Sep 2011
- First submitted
- 6 Oct 2009
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-randomized, Single-arm, Multi-center Study to Assess Localized Alveolar Ridge Augmentation Utilizing INFUSE® Bone Graft Concurrent With Space Maintenance Devices for Soft Tissue Management
- ClinicalTrials.gov ID
- NCT00991432
- Acronym / sponsor ID
- Ridge Mesh / P09-04
- Conditions
- Alveolar Bone Loss
- Keywords
- Alveolar Ridge Augmentation, Dental Implantation, Endosseous, Osseointegration, Space Maintenance, Bone Morphogenetic Proteins
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Averion International Corporation
- Study start
- Oct 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Oct 2009 (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.
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw in patients who are scheduled for surgery to have a dental implant(s) placed into the upper front part of their mouths and need to have more bone in their jaws to support the implant, so that a dental implant can later be inserted.
Detailed description
The INFUSE® Bone Graft is a device approved by the FDA to be used instead of using your own bone (from another site on your body) to replace missing bone in your jaw. INFUSE® Bone Graft is commercially available and is made up of 2 parts - recombinant human Bone Morphogenetic Protein-2 (rhBMP 2) placed on an absorbable collagen sponge (ACS). The rhBMP-2 is a genetically altered protein which recruits bone-forming cells to the surgical area and changes local cells to bone. ACS is made from Type I collagen from bovine (cattle) tendon. It helps to hold the rhBMP-2 in place and acts as a support for the growing bone. The sponge itself will reabsorb in time as the new bone forms.
The purpose of this research study is to determine whether this study treatment can improve the bone structure of the upper front part of the jaw so that a dental implant can later be inserted. This post-market study has been designed to further evaluate the effectiveness and safety of INFUSE® Bone Graft, along with space holding devices, in a 2-part procedure. Your dental implants will be placed at approximately 6 months after the INFUSE® Bone Graft implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INFUSE® Bone Graft | – | Device: INFUSE® Bone Graftall study participants will receive INFUSE® Bone Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients needing bone augmentation of the alveolar ridge
Key inclusion criteria (6 listed)
- Able to provide written informed consent
- ≥ 18 years
- Scheduled for dental implant into anterior maxillary alveolar ridge
- Negative urine pregnancy test for patients of child bearing potential and agreement not to become pregnant for at least 12 months after surgery
- Able to comply with all study-related procedures, including exercising good oral hygiene
Key exclusion criteria (18 listed)
- Known hypersensitivity to rhBMP-2, bovine Type I collagen or other components of the formulation
- Known hypersensitivity to titanium
- Operative site is in the area of a resected or extant tumor
- Any active malignancy or current treatment for a malignancy
- Active infection at operative site
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 |
|---|---|---|
| INFUSE® Bone GraftPatients will be treated with the commercially available INFUSE® Bone Graft material applied to an ACS concurrent with space maintenance devices for soft tissue management on Day 0 (Surgery). A follow-up visit will take place 2 weeks after implant of the INFUSE® Bone Graft material, or as regularly scheduled as per the standard of care (SOC) for the facility. Patients will return to the facility for final End of Study (EOS) assessments approximately 6 months after surgery. Between the follow-up visit and the EOS visit, patients will be seen as per the SOC schedule for the facility. | Device | INFUSE® Bone Graft |
Primary outcome
Alveolar ridge bone formation sufficient to place endosseous implants
Time frame: approximately 6 months post-surgery
1 secondary outcome
Evidence of successful INFUSE® Bone Graft placement, an increase in the alveolar ridge width and the safety of INFUSE® as assessed by CT scans.
Time frame: approximately 6 months post-surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Loss, run by Medtronic Spinal and Biologics at 8 sites 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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar ridge bone formation sufficient to place endosseous implants (time frame: approximately 6 months post-surgery). 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 Feb 2012.