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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.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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.

Israel1 site
  • Hadassah Medical Organization,

    Jerusalem, 91120

Other trials in Israel

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.

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.

  1. X-ray evaluation of osseointegration

    Measured: 3-6 12 months

  2. clinical assesment

    Measured: 3-6 and12

Secondary outcomes (1)
  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.

  1. First posted7 Mar 2006 (estimated)
  2. Study startDec 2007
  3. Primary completionMay 2008
  4. Study completionNov 2008 (estimated)

Why it stopped: manufacturer could not finance the study

Resources

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)
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 11074436
  • Charriere 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

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.

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