Alveolar Bone LossPhase 1/2OSSIXNCT00639860
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
A Phase 1/2 study testing OSSIX-Plus in people with Alveolar Bone Loss and Loss of Teeth Due to Extraction, run by William Giannobile at 1 site in United States.
Trial summary
The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Loss of Teeth Due to Extraction, Edentulous Alveolar Ridge
- What is being tested?
- OSSIX-Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
- Residual extraction sockets must have < 80% bone loss in all dimensions (3 or 4-walled bony defects)
- Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)
- Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments
- Subjects who read, understand and are willing to sign an informed consent statement
Who cannot join
- Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site
- Presence of acute infections at the time of tooth extraction
- Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth or other renal, hepatic, cardiac, endocrine, hematological, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
- History of head \& neck radiation therapy
- Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonatesm, medications affecting bone turnover, antibiotics for > 7 days or any investigational drug
- Patients who are or become pregnant during the length of the study
- Sites in which one or both adjacent teeth are missing
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
Official title: Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
The purpose of this study is to evaluate clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.
Read the detailed description
Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.
- Being tested
- OSSIX-Plus
- Keywords
- extraction, implant, alveolar ridge preservation
- 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.
OSSIX-PlusDevice
resorbable collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Placing OSSIX-Plus in Extraction Site | Experimental | Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. Receives: Device: OSSIX-Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Gain or Loss in Millimeters (Buccopalatal)
Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Measured: From Baseline to 12 weeks
Change in Bone Gain or Loss in Millimeters (Mesiodistal)
Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Measured: From Baseline to 12 weeks
Change in Bone Gain or Loss in Millimeters (Stent to Apex)
Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Measured: From Baseline to 12 weeks
Radiographic Bone Changes
Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).
Measured: From Baseline to 12 weeks
New Bone Formation
Percentage of new bone formation of the alveolar bone core biopsies.
Measured: From Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Giannobile
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson, OraPharma
- Responsible party
- Sponsor-investigator, William Giannobile, University of Michigan
- Investigators
- William V Giannobile, DDS, DMedSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639860
- Sponsor's protocol ID
- HUM00016574
- Acronym
- OSSIX
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2008
- Last updated
- 31 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):457-69.
PubMed 21845241
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
- ClinicalTrials.gov ID
- NCT00639860
- Acronym / sponsor ID
- OSSIX / HUM00016574
- Keywords
- extraction, implant, alveolar ridge preservation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- William GiannobileUniversity, hospital or other
- Collaborators
- Johnson & Johnson, OraPharma
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Posted 31 Mar 2016
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 clinically, histologically and radiographically the healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12 weeks following exodontia.
Detailed description
Reduction in alveolar ridge height and width may prohibit optimal implant placement, and often compromises the esthetic and functional result. Alveolar ridge preservation has been evaluated in many studies. A variety of bone grafting materials and barrier membranes have been studied for their ability to enhance bone formation in damaged alveolar ridges, and to evaluate their bone healing and bone-forming capacity in extraction sockets. However, the newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc., Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We hypothesize that use of OSSIX-Plus will result in preservation of the height, width and density of the residual alveolar ridge following tooth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placing OSSIX-Plus in Extraction Site | Experimental | Device: OSSIX-PlusPlacement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Systemically healthy subjects with 1 maxillary premolar tooth requiring extraction
- Residual extraction sockets must have < 80% bone loss in all dimensions (3 or 4-walled bony defects)
- Nonsmokers (individuals who quit smoking at least 6 months prior to the study will be allowed to participate)
- Subjects willing and able to comply with all study-related procedures including maintenance of good oral hygiene and compliance with re-evaluation appointments
- Subjects who read, understand and are willing to sign an informed consent statement
Key exclusion criteria (7 listed)
- Inadequate zone of keratinized gingiva (KG) or alveolar mucosa to obtain primary wound closure of the surgical site
- Presence of acute infections at the time of tooth extraction
- Clinically significant or unstable (as defined by the investigators) systemic diseases affecting bone or soft tissue growth or other renal, hepatic, cardiac, endocrine, hematological, autoimmune or acute infectious diseases that makes interpretation of the data more difficult
- History of head \& neck radiation therapy
- Subjects taking steroids, tetracycline or tetracycline analogs, bone therapeutic levels of fluorides, biphosphonatesm, medications affecting bone turnover, antibiotics for > 7 days or any investigational drug
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 |
|---|---|---|
| OSSIX-Plusresorbable collagen membrane | Device | Placing OSSIX-Plus in Extraction Site |
Primary outcome
Change in Bone Gain or Loss in Millimeters (Buccopalatal)
Time frame: From Baseline to 12 weeks
Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Change in Bone Gain or Loss in Millimeters (Mesiodistal)
Time frame: From Baseline to 12 weeks
Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Change in Bone Gain or Loss in Millimeters (Stent to Apex)
Time frame: From Baseline to 12 weeks
Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Radiographic Bone Changes
Time frame: From Baseline to 12 weeks
Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).
New Bone Formation
Time frame: From Baseline to 12 weeks
Percentage of new bone formation of the alveolar bone core biopsies.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21845241Neiva R, Pagni G, Duarte F, Park CH, Yi E, Holman LA, Giannobile WV. Analysis of tissue neogenesis in extraction sockets treated with guided bone regeneration: clinical, histologic, and micro-CT results. Int J Periodontics Restorative Dent. 2011 Sep-Oct;31(5):457-69.
- Individual participant dataSharing planned: No
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
William V Giannobile, DDS, DMedSc principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OSSIX-Plus in people with Alveolar Bone Loss and Loss of Teeth Due to Extraction, run by William Giannobile 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 31 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Bone Gain or Loss in Millimeters (Buccopalatal) (time frame: From Baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00639860, which also lists 1 linked publication.
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 31 Mar 2016.