Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299585
Status:
SUSPENDED
Last Update Posted:
2010-01-06
First Post:
2006-03-05
Brief Title:
A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Phase 2 Clinical Study on the Efficacy of Injectable Brushite Bone Cement in Bone Augmentation and Dental Implant Stabilization
Status:
SUSPENDED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
manufacturer could not finance the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 80s 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
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 80s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None