Alveolar Ridge AugmentationPhase 2NCT00299585
A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation
A Phase 2 study testing using "PD" VitalOs Cement with dental implants in people with Alveolar Ridge Augmentation and Dental Implants, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Objective: The evaluation of "PD" VitalOs Cement, an injectable brushite, as a stabilizer of dental implants and a potential source for bone augmentation. Methods: Forty (40) patients needing dental implants will be treated where needed with "PD" VitalOs Cement gapping half of their sites whereas the other half will… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Dental Implants
- What is being tested?
- using "PD" VitalOs Cement with dental implants
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to Nov 2008
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Partially or fully edentulous patients who need dental implants to support a prosthesis
Who cannot join
- Patients with uncontrolled diabetes
- Chemotherapy
- Immune suppressed
- Radiotherapy to head and neck in the last five years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Clinical Study on the Efficacy of Injectable Brushite Bone Cement in Bone Augmentation and Dental Implant Stabilization
Objective: The evaluation of "PD" VitalOs Cement, an injectable brushite, as a stabilizer of dental implants and a potential source for bone augmentation.
Methods: Forty (40) patients needing dental implants will be treated where needed with "PD" VitalOs Cement gapping half of their sites whereas the other half will be gapped with Bio-oss demineralized bone and BioGuide membrane.
Read the detailed description
Bone fractures or bone loss in specific sites are cases where a bone graft is sometimes needed to provide bone augmentation. For bone fractures, these are typically metaphyseal or maxillofacial fractures with risk of malunion or non-union. Bone loss can happen under various circumstances: it can be a consequence of a systemic disease like osteoporosis or of a surgical intervention like the extraction of a tooth or the removal of a bone cyst or tumor.
When a bone graft is required the gold standard still widely used is autogenous cancellous bone. However, the graft harvesting procedure is invasive and increases patient morbidity (lengthened surgical procedure, increased risk of infection). Moreover, the availability of autologous grafts is limited, especially in elderly patients. This has been the rationale for studying alternative sources for bone grafts.
The first alternative is allografts: they are usually obtained from cadavers. The advantages include elimination of a patient donor site, hence reduced surgical time and decreased blood loss and risk of infection. The principal shortcomings are the availability, the possible rejection of the graft and the risk of disease transmission.
Grafts of animal origin (xenografts) are also an option, even though not totally risk-free when it comes to disease transmission.
A third alternative to autologous bone is to use synthetic materials. Extensive research has been performed to develop such materials since the 80's. The majority of them are based on calcium phosphate compounds, made up of the same ions as those of the natural mineral phase of bone. These products are readily available, eliminate the risk of disease transmission or immunogenic response (allografts) and bypass the need for an additional surgical procedure (autografts). These materials are presented under either of the three forms: granules, pre-formed blocks or cements.
Granules and pre-formed blocks are generally made up of β-TCP, Hydroxyapatite (HA), or a mix of both. Depending mainly on their chemical composition, their manufacturing process and their porosity, they degrade more or less rapidly.
Calcium phosphate cements consist generally of a liquid and a powder which harden upon mixing. The final product phase can be hydroxyapatite, or another calcium phosphate phase like dahllite or brushite. The advantage of cements over pre-formed blocks is that they can be injected, shaped and hardened in situ, ensuring optimum bone-implant contact and minimally invasive surgery. Once hardened, they exhibit cohesive properties that granules cannot provide. Most of the calcium phosphate cements available on the market are hydroxyapatite cements. However, for some applications like periodontitis or peri-implant gap filling, their resorption rate is too slow, hampering their clinical applicability for these indications. The advantage of the brushite phase in the hardened cement is that it degrades faster than hydroxyapatite, allowing a more rapid bone regeneration. The purpose of this study is to evaluate the efficacy of "PD" VitalOs Cement as a primary stabilizer and bone augmenting source in dental implantology.
- Conditions
- Alveolar Ridge Augmentation, Dental Implants
- Being tested
- using "PD" VitalOs Cement with dental implants
- Keywords
- dental implant, dental implantation, osseointegration, bone cement, osteoconductivity, brushite, calcium phosphate, bone augmentation, primary stability, immediate implantation, Mandibular Ridge Augmentation, Maxillary Ridge Augmentation, synthetic implants for rebuilding the alveolar ridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using "PD" VitalOs Cement with dental implantsProcedure or surgery
supporting dental implants with Vitalos bone cement
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray evaluation of osseointegration
Measured: 3-6 12 months
clinical assesment
Measured: 3-6 and12
Secondary outcomes (1)
long-term follow-up for osseointegration: clinical and X-ray
Measured: 12-18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startDec 2007
- Primary completionMay 2008
- Study completionNov 2008 (estimated)
Why it stopped: manufacturer could not finance the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Michael M Perez Davidi, DMD, Study chair, Hadassah Medical OrganizationNardi Caspi, DMD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299585
- Sponsor's protocol ID
- 191059 HMO-CTIL
- Status last verified
- Dec 2007
- First submitted
- 5 Mar 2006
- Last updated
- 6 Jan 2010
- Results posted
- No
Publications
Pittet C, Lemaitre J. Mechanical characterization of brushite cements: a Mohr circles' approach. J Biomed Mater Res. 2000;53(6):769-80. doi: 10.1002/1097-4636(2000)53:63.0.co;2-p.
PubMed 11074436Charriere E, Terrazzoni S, Pittet C, Mordasini PH, Dutoit M, Lemaitre J, Zysset PH. Mechanical characterization of brushite and hydroxyapatite cements. Biomaterials. 2001 Nov;22(21):2937-45. doi: 10.1016/s0142-9612(01)00041-2.
PubMed 11561900
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Study on the Efficacy of Injectable Brushite Bone Cement in Bone Augmentation and Dental Implant Stabilization
- ClinicalTrials.gov ID
- NCT00299585
- Acronym / sponsor ID
- 191059 HMO-CTIL
- Conditions
- Alveolar Ridge Augmentation, Dental Implants
- Keywords
- dental implant, dental implantation, osseointegration, bone cement, osteoconductivity, brushite, calcium phosphate, bone augmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: manufacturer could not finance the study
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Nov 2008 (estimated)
- First posted
- 7 Mar 2006 (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.
Objective: The evaluation of "PD" VitalOs Cement, an injectable brushite, as a stabilizer of dental implants and a potential source for bone augmentation.
Methods: Forty (40) patients needing dental implants will be treated where needed with "PD" VitalOs Cement gapping half of their sites whereas the other half will be gapped with Bio-oss demineralized bone and BioGuide membrane.
Detailed description
Bone fractures or bone loss in specific sites are cases where a bone graft is sometimes needed to provide bone augmentation. For bone fractures, these are typically metaphyseal or maxillofacial fractures with risk of malunion or non-union. Bone loss can happen under various circumstances: it can be a consequence of a systemic disease like osteoporosis or of a surgical intervention like the extraction of a tooth or the removal of a bone cyst or tumor.
When a bone graft is required the gold standard still widely used is autogenous cancellous bone. However, the graft harvesting procedure is invasive and increases patient morbidity (lengthened surgical procedure, increased risk of infection). Moreover, the availability of autologous grafts is limited, especially in elderly patients. This has been the rationale for studying alternative sources for bone grafts.
The first alternative is allografts: they are usually obtained from cadavers. The advantages include elimination of a patient donor site, hence reduced surgical time and decreased blood loss and risk of infection. The principal shortcomings are the availability, the possible rejection of the graft and the risk of disease transmission.
Grafts of animal origin (xenografts) are also an option, even though not totally risk-free when it comes to disease transmission.
A third alternative to autologous bone is to use synthetic materials. Extensive research has been performed to develop such materials since the 80's. The majority of them are based on calcium phosphate compounds, made up of the same ions as those of the natural mineral phase of bone. These products are readily available, eliminate the risk of disease transmission or immunogenic response (allografts) and bypass the need for an additional surgical procedure (autografts). These materials are presented under either of the three forms: granules, pre-formed blocks or cements.
Granules and pre-formed blocks are generally made up of β-TCP, Hydroxyapatite (HA), or a mix of both. Depending mainly on their chemical composition, their manufacturing process and their porosity, they degrade more or less rapidly.
Calcium phosphate cements consist generally of a liquid and a powder which harden upon mixing. The final product phase can be hydroxyapatite, or another calcium phosphate phase like dahllite or brushite. The advantage of cements over pre-formed blocks is that they can be injected, shaped and hardened in situ, ensuring optimum bone-implant contact and minimally invasive surgery. Once hardened, they exhibit cohesive properties that granules cannot provide. Most of the calcium phosphate cements available on the market are hydroxyapatite cements. However, for some applications like periodontitis or peri-implant gap filling, their resorption rate is too slow, hampering their clinical applicability for these indications. The advantage of the brushite phase in the hardened cement is that it degrades faster than hydroxyapatite, allowing a more rapid bone regeneration. The purpose of this study is to evaluate the efficacy of "PD" VitalOs Cement as a primary stabilizer and bone augmenting source in dental implantology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Partially or fully edentulous patients who need dental implants to support a prosthesis
Key exclusion criteria (4 listed)
- Patients with uncontrolled diabetes
- Chemotherapy
- Immune suppressed
- Radiotherapy to head and neck in the last five years
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 |
|---|---|---|
| using "PD" VitalOs Cement with dental implantssupporting dental implants with Vitalos bone cement | Procedure or surgery | – |
Primary outcome
X-ray evaluation of osseointegration
Time frame: 3-6 12 months
clinical assesment
Time frame: 3-6 and12
1 secondary outcome
long-term follow-up for osseointegration: clinical and X-ray
Time frame: 12-18-24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
- Background: PubMed 11074436Pittet C, Lemaitre J. Mechanical characterization of brushite cements: a Mohr circles' approach. J Biomed Mater Res. 2000;53(6):769-80. doi: 10.1002/1097-4636(2000)53:63.0.co;2-p.
- Results publication: PubMed 11561900Charriere E, Terrazzoni S, Pittet C, Mordasini PH, Dutoit M, Lemaitre J, Zysset PH. Mechanical characterization of brushite and hydroxyapatite cements. Biomaterials. 2001 Nov;22(21):2937-45. doi: 10.1016/s0142-9612(01)00041-2.
- Michael Perez DavidiLink provided by the sponsor.
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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.
Michael M Perez Davidi, DMD study chair
Hadassah Medical Organization
Nardi Caspi, DMD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing using "PD" VitalOs Cement with dental implants in people with Alveolar Ridge Augmentation and Dental Implants, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 4 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: paused, as of the sponsor's last update on 6 Jan 2010. 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 Israel. 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 phase mean?
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?
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?
X-ray evaluation of osseointegration (time frame: 3-6 12 months). The study lists 2 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 NCT00299585, which also lists 2 linked publications.
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 6 Jan 2010.