A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation
TThis study is not yet open for patient recruitment
Verified by Hadassah Medical Organization September 2006
|Sponsors and Collaborators:
||Hadassah Medical Organization
|Information provided by:
||Hadassah Medical Organization
Objective: evaluation of “PD” VitalOs Cement,an injectable brushite,as stabilizer of dental implant and potential sorce for bone augmentation.
Methods: 40 patients needing dental implants will be treated where needed with “PD” VitalOs Cement gapping halve of their sites where as the other halve will be gapped with Bio oss demineralized bone and bioguide membrane.
|Alveolar Ridge Augmentation
Mandibular Ridge Augmentation
Maxillary Ridge Augmentation
Synthetic Implants for Rebuilding the Alveolar Ridge.
|Procedure: using calcium phosphate bone cement with dental implants
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Expanded Access Assignment, Safety/Efficacy Study
Official Title: phase2 Clinical Study on the Efficacy of Injectable Brushite Bone Cement in Bone Augmentation and Dental Implant Stabilization.
Further study details as provided by Hadassah Medical Organization:
Primary Outcomes: Xray evaluation of osseointegration; periosens for osseointegration; clinical stability after 6 months
Secondary Outcomes: long term followup for osseointegration clinical and Xray
Expected Total Enrollment:
Study start: October 2006
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 maxillo-facial 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.
Genders Eligible for Study:
Accepts Healthy Volunteers
- partial or full edentulous patients who need dental implants to support a prosthesis
- patients with uncontrolled diabetes
- immune suppressed
- radiotherapy to head and neck in the last five years
Please refer to this study by ClinicalTrials.gov identifier
Hadassah Medical Organization,, Jerusalem,,
Study chairs or principal investigators
Michael M Perez Davidi, DMD, Study Chair, Hadassah Medical Organization
Nardi Caspi, DMD, Principal Investigator, Hadassah Medical Organization
Pittet C, Lemaitre J. Mechanical characterization of brushite cements: a Mohr circles' approach. J Biomed Mater Res. 2000;53(6):769-80.
Publications that report results of this study
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.
Study ID Numbers:
September 14, 2006
Record first received:
March 5, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-10-19