A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation

Dental Implants Clinical Trial

Official title:

Phase 2 Clinical Study on the Efficacy of Injectable Brushite Bone Cement in Bone Augmentation and Dental Implant Stabilization

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00299585
• Other study ID #: 191059 HMO-CTIL
• Status: Suspended
• Phase: Phase 2
• First received: March 5, 2006
• Last updated: January 5, 2010
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2007
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical 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 be gapped with Bio-oss demineralized bone and BioGuide membrane.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Partially or fully edentulous patients who need dental implants to support a prosthesis

Exclusion Criteria:

• Patients with uncontrolled diabetes

• Chemotherapy

• Immune suppressed

• Radiotherapy to head and neck in the last five years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolar Ridge Augmentation
• Dental Implants

Intervention

Procedure:
• using "PD" VitalOs Cement with dental implants
supporting dental implants with Vitalos bone cement

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization,	Jerusalem,

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Charrière E, Terrazzoni S, Pittet C, Mordasini PH, Dutoit M, Lemaître J, Zysset PH. Mechanical characterization of brushite and hydroxyapatite cements. Biomaterials. 2001 Nov;22(21):2937-45. — View Citation

Pittet C, Lemaître J. Mechanical characterization of brushite cements: a Mohr circles' approach. J Biomed Mater Res. 2000;53(6):769-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	X-ray evaluation of osseointegration		3-6 12 months	No
Primary	clinical assesment		3-6 and12	No
Secondary	long-term follow-up for osseointegration: clinical and X-ray		12-18-24 months	No

External Links

•   Michael Perez Davidi