Alveolar Bone Loss in MandibleNCT01308996
Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation
A study testing INFUSE® Bone Graft and Autogenous bone graft from tibia or iliac crest in people with Alveolar Bone Loss in Mandible and Edentulous Alveolar Ridge In Mandible, run by Medtronic Spinal and Biologics.
Trial summary
The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental implants. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Alveolar Bone Loss in Mandible, Edentulous Alveolar Ridge In Mandible
- What is being tested?
- INFUSE® Bone Graft and Autogenous bone graft from tibia or iliac crest
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Sep 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has been edentulous for at least 2 months with an alveolar ridge defect affecting 2-4 teeth in the posterior mandible, posterior to the canine.
- Has an alveolar ridge defect with a minimum starting height of 5 mm above the superior cortex of the inferior alveolar canal in the posterior mandible.
- Is a candidate for dental implants (2-4 teeth) in the affected posterior mandibular alveolar ridge area.
- Has a prosthodontic treatment plan in place.
- Has no known condition that would interfere with collecting autogenous bone at either the tibia or the iliac crest for a bone grafting procedure.
- Is 21-75 years of age (inclusive).
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- If female of childbearing potential, has a negative urine pregnancy test, is not lactating, and agrees not to become pregnant for at least 12 months after surgery.
- Is able to comply with all study-related procedures, including exercising good oral hygiene.
- Is able to provide written informed consent.
Who cannot join
- Has bilateral alveolar ridge defects requiring simultaneous augmentation or a second augmentation planned during the course of the study.
- Has an active infection at the planned augmentation site.
- Has active periodontal disease of Grade III or higher.
- Has had a dental extraction procedure at the planned augmentation site within the 2 months prior to Day 0.
- Has had a soft tissue graft at the planned augmentation site within less than 2 weeks of Screening.
- Is expected to require any additional bone graft material (e.g., allograft and xenograft) at the planned augmentation site in addition to the investigative treatment or autogenous bone, as determined by the investigator prior to surgery.
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- Has a history of a failed alveolar ridge augmentation procedure.
- Has a pathology finding that would either compromise a bone grafting procedure or interfere with obtaining quantitative measurements from postoperative CT scans.
- Is an insulin-dependent diabetic.
- Has an overt or active systemic infection, such as human immunodeficiency virus (HIV), bacteremia, or hepatitis C virus (HCV).
- Has a planned augmentation site in the area of a resected or extant tumor.
- Has presence of an active malignancy or prior history of malignancy (except for basal cell carcinoma of the skin).
- Is actively using any nicotine-containing products such as, but not limited to, smoking and chewing tobacco, nicotine patch, nicotine gum, etc. within 2 weeks prior to Screening.
- Is alcohol or drug dependent, as determined by the investigator.
- Is taking medications or having treatment known to have an effect on bone metabolism, such as, but not limited to:
- calcitonin within the past 6 months;
- fluorides for 30 days or more within the past 12 months;
- cumulative use of oral bisphosphonates for less than 5 years within the past 6 months;
- cumulative use of oral bisphosphonates for 5 years or more;
- any previous use of intravenous bisphosphonates;
- chronic tetracycline (e.g., ongoing within the past month) or tetracycline analogs within the past 12 months;
- estrogen replacement therapy within the past 2 months; or
- methotrexate within the past 12 months.
- Has a disease that affects bone metabolism, such as:
- congenital connective tissue disease (e.g., Ehlers-Danlos syndrome, osteogenesis imperfecta);
- hyperthyroidism; or
- hyperparathyroidism.
- Has a history of autoimmune disease (e.g., systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis, etc.).
- Has any previous exposure to any recombinant BMPs of either human or animal extraction.
- Has a known history of prior exposure to silicone or injectable collagen implants.
- Has a known hypersensitivity or allergy to collagen or protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins).
- Has a known hypersensitivity or allergy to titanium.
- Has a history of allergy to bovine collagen products.
- Has chronic or acute renal failure
- Has chronic or acute liver failure.
- Has received treatment with an investigational therapy (drug, device, and/or biologic) within 30 days prior to bone graft implantation surgery or such treatment is planned during the 12-month period following the study surgery.
- Has any condition that in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study.
About this study
Official title: A Prospective, Open Label, Randomized, Multicenter, Controlled Clinical Study of INFUSE® Bone Graft Used as an Alternative to Autogenous Bone Graft for Vertical Alveolar Ridge Augmentation
The purpose of this study is to evaluate the INFUSE® Bone Graft as an alternative to autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental implants.
Read the detailed description
The purpose of this study is to evaluate INFUSE® Bone Graft as an alternative to autograft for alveolar ridge bone formation in the posterior mandible prior to dental implants. A subject must have a defect behind the canine of 2-4 teeth for at least 2 months and be a candidate for dental implants.
- Being tested
- INFUSE® Bone Graft, Autogenous bone graft from tibia or iliac crest
- Keywords
- alveolar ridge augmentation, edentulous ridge, alveolar ridge defect, posterior mandible defect, bone morphogenic protein, osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INFUSE® Bone GraftDevice
Implantation of INFUSE® Bone Graft [recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)] and absorbable collagen sponge (ACS) carrier at 1.50 mg/cc with space maintenance device
Autogenous bone graft from tibia or iliac crestProcedure or surgery
Implantation of autogenous bone graft from iliac crest or tibia with titanium mesh space maintenance device
| Study group | Role | What they receive |
|---|---|---|
| INFUSE® Bone Graft | Experimental | Not described Receives: Device: INFUSE® Bone Graft |
| Autogenous bone graft | Active comparator | Not described Receives: Procedure: Autogenous bone graft from tibia or iliac crest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseous volumetric fill underneath the titanium mesh of edentulous sites in the posterior mandible.
Measured: 210 days
Secondary outcomes (5)
Pain level at the surgical site, as well as at the donor site (if applicable).
Numerical rating scales used to evaluate pain intensity and frequency.
Measured: 210 days
Ability to place dental implants
Measured: 210 days
Histological evaluation (percent vital bone)
Measured: 210 days
Surgical failure rate
Measured: 210 days
Adverse Events
Measured: 210 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startApr 2012
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone Loss in MandibleStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Averion International Corporation, Baim Institute for Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308996
- Sponsor's protocol ID
- G100313
- Status last verified
- Aug 2012
- First submitted
- 2 Mar 2011
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Randomized, Multicenter, Controlled Clinical Study of INFUSE® Bone Graft Used as an Alternative to Autogenous Bone Graft for Vertical Alveolar Ridge Augmentation
- ClinicalTrials.gov ID
- NCT01308996
- Acronym / sponsor ID
- G100313
- Keywords
- alveolar ridge augmentation, edentulous ridge, alveolar ridge defect, posterior mandible defect, bone morphogenic protein, osseointegration
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Averion International Corporation, Baim Institute for Clinical Research
- Study start
- Apr 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 Mar 2011 (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 study is to evaluate the INFUSE® Bone Graft as an alternative to autograft for bone formation in the back of the mandible (lower jaw) prior to placing dental implants.
Detailed description
The purpose of this study is to evaluate INFUSE® Bone Graft as an alternative to autograft for alveolar ridge bone formation in the posterior mandible prior to dental implants. A subject must have a defect behind the canine of 2-4 teeth for at least 2 months and be a candidate for dental implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INFUSE® Bone Graft | Experimental | Device: INFUSE® Bone Graft |
| Autogenous bone graft | Active comparator | Procedure: Autogenous bone graft from tibia or iliac crest |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has been edentulous for at least 2 months with an alveolar ridge defect affecting 2-4 teeth in the posterior mandible, posterior to the canine.
- Has an alveolar ridge defect with a minimum starting height of 5 mm above the superior cortex of the inferior alveolar canal in the posterior mandible.
- Is a candidate for dental implants (2-4 teeth) in the affected posterior mandibular alveolar ridge area.
- Has a prosthodontic treatment plan in place.
- Has no known condition that would interfere with collecting autogenous bone at either the tibia or the iliac crest for a bone grafting procedure.
Key exclusion criteria (37 listed)
- Has bilateral alveolar ridge defects requiring simultaneous augmentation or a second augmentation planned during the course of the study.
- Has an active infection at the planned augmentation site.
- Has active periodontal disease of Grade III or higher.
- Has had a dental extraction procedure at the planned augmentation site within the 2 months prior to Day 0.
- Has had a soft tissue graft at the planned augmentation site within less than 2 weeks of Screening.
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 GraftImplantation of INFUSE® Bone Graft [recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)] and absorbable collagen sponge (ACS) carrier at 1.50 mg/cc with space maintenance device | Device | INFUSE® Bone Graft |
| Autogenous bone graft from tibia or iliac crestImplantation of autogenous bone graft from iliac crest or tibia with titanium mesh space maintenance device | Procedure or surgery | Autogenous bone graft |
Primary outcome
Osseous volumetric fill underneath the titanium mesh of edentulous sites in the posterior mandible.
Time frame: 210 days
5 secondary outcomes
Pain level at the surgical site, as well as at the donor site (if applicable).
Time frame: 210 days
Ability to place dental implants
Time frame: 210 days
Histological evaluation (percent vital bone)
Time frame: 210 days
Surgical failure rate
Time frame: 210 days
Adverse Events
Time frame: 210 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing INFUSE® Bone Graft and Autogenous bone graft from tibia or iliac crest in people with Alveolar Bone Loss in Mandible and Edentulous Alveolar Ridge In Mandible, run by Medtronic Spinal and Biologics.
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 9 inclusion and 37 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: withdrawn, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Osseous volumetric fill underneath the titanium mesh of edentulous sites in the posterior mandible. (time frame: 210 days). 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 13 Sep 2018.