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periophil b-tcp
Cytophil
Summary: Periophil b-tcp is a beta-tricalcium phosphate device used in bone grafting procedures. It is primarily indicated for bone regeneration in dental and orthopedic applications. Key evidence highlights its role in sinus-lift procedures and critical bone defect repairs.
FDA Clearance Information
Pathway
510K
Number
K093871 ↗
Decision Date
April 22, 2010
Product Code
LYC
Device Class
Class 2
Evidence
419 studies
Periophil b-tcp was cleared by the FDA via the 510(k) pathway on April 22, 2010. It is manufactured by Cytophil and classified as a Class 2 medical device under product code LYC.
What It Is
Periophil b-tcp is a synthetic bone graft substitute composed of beta-tricalcium phosphate. It is designed to support bone regeneration by providing a scaffold for new bone growth, commonly used in dental and orthopedic procedures.
Clinical Applications
Periophil b-tcp is frequently used in sinus-lift procedures to increase bone height for dental implants and in the repair of critical bone defects. It provides a bioactive scaffold that facilitates bone regeneration in these contexts.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. These studies span from 2023 to 2025 and investigate the efficacy and safety of beta-tricalcium phosphate in various clinical settings.
Reported Outcomes
Published studies report that periophil b-tcp effectively supports bone regeneration in sinus-lift procedures and critical bone defect repairs. It has been shown to enhance bone height and quality, facilitating successful implant placement. Studies also highlight its potential as a bioactive material in regenerative therapies.
Safety Profile
Reported complications include typical post-surgical issues such as inflammation and infection, which are generally manageable with standard care. No significant adverse events specific to periophil b-tcp have been consistently reported in the literature.
Evidence Limitations
The evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term outcomes and to compare periophil b-tcp with other bone graft materials in diverse patient populations.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What are the clinical indications for periophil b-tcp?
Periophil b-tcp is indicated for use in bone regeneration procedures, such as sinus-lift surgeries and the repair of critical bone defects.
What outcomes have been reported in clinical studies?
Studies report effective bone regeneration, improved bone height and quality, and successful implant placement when using periophil b-tcp.
What complications have been reported?
Reported complications include inflammation and infection, which are typical post-surgical issues and generally manageable.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.