Study Stopped
manufacturer could not finance the study
A Clinical Study of the Use of Brushite as Primary Stabilizer in Immediate Dental Implantation
Phase 2 Clinical Study on the Efficacy of Injectable Brushite Bone Cement in Bone Augmentation and Dental Implant Stabilization
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2006
CompletedFirst Posted
Study publicly available on registry
March 7, 2006
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedJanuary 6, 2010
December 1, 2007
5 months
March 5, 2006
January 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
X-ray evaluation of osseointegration
3-6 12 months
clinical assesment
3-6 and12
Secondary Outcomes (1)
long-term follow-up for osseointegration: clinical and X-ray
12-18-24 months
Interventions
supporting dental implants with Vitalos bone cement
Eligibility Criteria
You may qualify if:
- Partially or fully edentulous patients who need dental implants to support a prosthesis
You may not qualify if:
- Patients with uncontrolled diabetes
- Chemotherapy
- Immune suppressed
- Radiotherapy to head and neck in the last five years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Medical Organization,
Jerusalem, 91120, Israel
Related Publications (2)
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.
PMID: 11074436BACKGROUNDCharriere 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.
PMID: 11561900RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael M Perez Davidi, DMD
Hadassah Medical Organization
- PRINCIPAL INVESTIGATOR
Nardi Caspi, DMD
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 5, 2006
First Posted
March 7, 2006
Study Start
December 1, 2007
Primary Completion
May 1, 2008
Study Completion
November 1, 2008
Last Updated
January 6, 2010
Record last verified: 2007-12