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Revitalex Prefilled Inj. PDRN

A prefilled injection syringe consisting of a colorless, transparent plastic barrel filled with a clear solution and sealed with rubber stoppers on both ends.

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SKU: RPN17160
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Description

Product Name : Revitalex Prefilled Injection (Polydeoxyribonucleotide Sodium)

Product Category: Prescription Drug
Active Ingredient: Polydeoxyribonucleotide Sodium 5.625 mg / 1 syringe (3 mL)
Indications and Effects: Post-Skin Grafting Wound Management and Tissue Restoration
AppearanceA prefilled injection syringe consisting of a colorless, transparent plastic barrel filled with a clear solution and sealed with rubber stoppers on both ends.
Pack contains: 1 prefilled syringe (3 mL)
Storage Instructions: Store in a sealed container at room temperature.

 

Polydeoxyribonucleotide(PDRN) is administered as an injectable formulation, with each 3 mL syringe containing 5.625 mg of the active ingredient. It is primarily used to promote wound healing and tissue regeneration following skin graft procedures by stimulating fibroblast proliferation and facilitating tissue repair.

This compound exhibits the following therapeutic properties:

  • Tissue regeneration: Enhances the production of growth factors and cytokines, accelerating the wound healing process.
  • Anti-inflammatory effects: Suppresses inflammatory mediators, thereby reducing swelling and pain.
  • Improved blood circulation: Promotes angiogenesis, ensuring adequate oxygen and nutrient delivery to the damaged area.

It is typically administered once daily via intramuscular or subcutaneous injection and should only be used under the supervision of a qualified healthcare professional.

 

Cautions to use

1. Contraindications

This drug should not be administered to patients with hypersensitivity to the active ingredient or any of the excipients contained in this product.

 

2. General Precautions
If hypersensitivity reactions occur following administration, discontinue use immediately and provide appropriate medical treatment.

 

3. Drug Interactions
No studies have been conducted regarding interactions between this drug and other medications.

 

4. Post-Marketing Surveillance in Korea
A post-marketing surveillance study was conducted over six years in Korea involving 609 patients for re-evaluation purposes. The incidence of adverse events, regardless of causality, was reported at 0.99% (6 out of 609 patients, 7 cases in total). Reported events included pruritic rash, oropharyngeal pain, vomiting, leukopenia, abdominal pain, diarrhea, and nausea—each occurring once. No serious or unexpected adverse events were reported.

 

※ Re-evaluation Safety Analysis Summary
An integrated analysis of domestic re-evaluation data and spontaneous adverse event reports for this drug, compared with adverse event data from all other approved pharmaceuticals in Korea at the time of re-evaluation, revealed no statistically significant increase in adverse event reporting for this product.

 

 

Stimulation of cell formation: PDRN promotes proliferation of human skin fibroblast. PDRN induces VEGF (Vascular Endothelial Cell Growth Factor), resulting in angiogenesis and improved blood flow. PDRN produces nucleotides and nucleosides, used when forming DNA and activating normal cell proliferation and growth. This regenerative product helps restore skin moisture levels, reduce pigmentation, shrink pores and increase collagen production, which depletes with age.

  • Approved by the MFDS Korea (Ministry of Food and Drug Safety)
  • Regenerative and stimulates fibroblast formation in the skin
  • Quality manufacturing process through high-temperature extraction and purification
  • Loaded with good fats and co-factors, PDRN speeds healing and reduces inflammation after skin procedures.
  • Includes vascular endothelial growth factor (VEGF), which stimulates new blood vessels and improves blood circulation
  • Stimulates the synthesis of nucleotides and nucleosides used in DNA formation, activating the normal formation and growth of cells
  • High PDRN concentration: 50-1500 kDa (DNA) and 5,626mg polydeoxyribonucleotide 5.6%

Made in South Korea

 

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Role of PDRN

Introduction to PDRN

Polydeoxyribonucleotide, commonly referred to as PDRN, is a nucleic acid derivative that has garnered attention in various medical fields, including dentistry. This biomolecule is primarily derived from the DNA of salmon sperm, which has been shown to undergo a rigorous purification process to extract PDRN effectively. This extraction procedure ensures the preservation of its essential biochemical properties, which render it remarkably bioactive and beneficial for tissue regeneration. The significance of PDRN in promoting healing and tissue regeneration stems from its unique structural characteristics. PDRN is composed of short chains of deoxyribonucleotides, which play a pivotal role in cellular repair mechanisms. When administered, PDRN interacts with the nucleic acid pathways of resident cells, stimulating processes that enhance cellular proliferation, angiogenesis, and fibroblast activity. These actions contribute to accelerated healing, making PDRN an innovative adjunct in dental therapies. Research indicates that the application of PDRN can result in significant improvements in tissue healing in cases such as oral surgery, periodontal therapies, and maxillofacial reconstruction. Its ability to reduce inflammation and facilitate faster recovery underscores its potential as a transformative agent in clinical dentistry. Moreover, PDRN can also enhance the outcomes of procedures by improving graft integration and reducing postoperative discomfort for patients. As the understanding of PDRN expands, so does its potential in the dental field. Ongoing studies aim to elucidate further its mechanisms of action and the full spectrum of its therapeutic applications. This not only highlights the current relevance of PDRN in enhancing dental practices but also sets the foundation for future explorations that could redefine standards of care in dentistry.  

Current Applications of PDRN in Dental Practice

Polydeoxyribonucleotide (PDRN) has emerged as a significant biomolecule in the realm of dentistry, with various applications that enhance healing and tissue regeneration. One of the primary uses of PDRN is in periodontal therapy, where it aids in the treatment of periodontal disease. PDRN has been shown to promote the proliferation and migration of fibroblasts, which are essential for the regeneration of connective tissues. This not only reduces the depth of periodontal pockets but also enhances tissue quality, resulting in improved clinical outcomes. In addition to its role in periodontal treatments, PDRN is increasingly utilized in dental implantology. The success of dental implants heavily relies on osseointegration—the process by which the implant fuses with the jawbone. PDRN has been found to stimulate osteogenic differentiation, thereby accelerating bone regeneration in the implant site. The incorporation of PDRN in dental implant procedures has been linked to reduced healing time and improved stability of the implant, thus promoting a successful outcome. Oral surgery is another field where the applications of PDRN are gaining traction. Post-surgical healing can often be complicated by inflammation and extended recovery times. However, the anti-inflammatory properties of PDRN help mitigate these challenges. By reducing swelling and optimizing the healing process, PDRN contributes to a more favorable postoperative experience for patients. Furthermore, it aids in the reduction of complications by promoting faster and more effective tissue regeneration following surgical interventions. Overall, the incorporation of PDRN into dental practice is revolutionizing patient care by enhancing healing, reducing inflammation, and promoting tissue regeneration. As research advances, its applications may expand further, solidifying PDRN’s role as a vital component in contemporary dental treatments.  

Mechanisms of Action: How PDRN Promotes Healing

The application of Polydeoxyribonucleotide (PDRN) in dentistry is rooted in its unique biological properties, primarily its ability to promote healing through several critical mechanisms. One of the most significant actions of PDRN is its role in stimulating angiogenesis, the formation of new blood vessels from existing ones. This process is vital in dental procedures, particularly in promoting tissue recovery after surgical intervention or trauma. By enhancing blood flow, PDRN ensures an adequate supply of nutrients and oxygen, which are essential for healing and tissue regeneration. Furthermore, PDRN has been shown to promote cell proliferation. This effect is primarily attributed to its interaction with the adenosine A2A receptor, leading to the activation of various signaling pathways that encourage cell growth and division. In dental applications, this can be particularly beneficial for regenerating periodontal tissues and bone, thereby expediting recovery times and improving outcomes following procedures such as tooth extractions or implant placements. In addition to stimulating angiogenesis and promoting cellular proliferation, PDRN also plays a significant role in modulating inflammatory responses. By balancing the immune response, PDRN helps to minimize excessive inflammation that often accompanies dental procedures. This modulation is crucial, as prolonged inflammation can hinder the healing process and lead to complications such as infections or chronic pain. The attenuation of inflammatory processes through PDRN not only aids in better recovery but also enhances patient comfort. In essence, the comprehensive mechanisms of action of PDRN—its ability to stimulate new blood vessel formation, promote the growth of crucial cells, and regulate inflammation—underscore its significant potential in contemporary dental practices. As research continues to unveil the full spectrum of PDRN’s capabilities, its relevance in enhancing healing outcomes in dentistry becomes increasingly apparent.  

Clinical Studies and Evidence Supporting PDRN Use

Recent clinical studies have begun to shed light on the various applications of Polydeoxyribonucleotide (PDRN) in dentistry, particularly focusing on its effectiveness in enhancing healing processes following dental procedures. A significant number of trials have examined PDRN’s role in promoting tissue regeneration and reducing recovery times in patients. For instance, one study reported that patients receiving PDRN injections post-surgery exhibited a marked improvement in wound healing speed compared to those who did not receive the treatment. These findings suggest that PDRN can play a crucial role in accelerating tissue repair, which is a fundamental aspect of dental aftercare. Moreover, another notable clinical trial assessed patient satisfaction levels and overall treatment success rates when PDRN was used as part of dental implant procedures. Results indicated higher satisfaction scores among patients who were administered PDRN, as they reported decreased pain levels and discomfort post-operation. This highlights PDRN’s potential not just to aid in physical healing but to enhance the overall patient experience during recovery. Further investigation into PDRN’s applications has revealed its effectiveness in managing conditions such as oral ulcers and periodontitis. Clinical trials focusing on these specific conditions demonstrated that PDRN treatments could lead to significant reductions in inflammation and pain, contributing to improved clinical outcomes. Overall, the data collected from these studies illustrates a positive trend, suggesting that PDRN is a valuable addition to the therapeutic arsenal in dentistry. As the body of research expands, it becomes increasingly evident that PDRN not only improves healing times but also elevates patient satisfaction, thereby reinforcing the importance of integrating this bioregulator into routine dental practice.  

Patient Benefits of PDRN in Dentistry

The application of polydeoxyribonucleotide (PDRN) in dentistry has garnered considerable attention due to its potential to enhance patient outcomes in various dental procedures. One of the primary benefits that patients experience from PDRN treatments is the significant reduction in recovery times. Traditional surgical interventions often involve extended periods of healing; however, PDRN has been shown to expedite the regeneration of tissues, thus facilitating a quicker return to normalcy for patients. This is especially beneficial for those undergoing invasive dental surgeries such as extractions or implants. Additionally, the use of PDRN in dentistry has been linked to decreased pain and discomfort post-operatively. By promoting cellular repair and reducing inflammation, PDRN not only alleviates the severity of pain but also minimizes the need for opioid medications, which are commonly prescribed after dental procedures. This shift towards minimizing pharmacological pain management represents a significant enhancement in patient care and comfort, leading to a more positive overall experience. Improved outcomes for dental surgeries are another notable advantage associated with PDRN utilization. Research indicates that the application of PDRN can enhance wound healing, leading to fewer complications such as infections or delayed healing. This is particularly salient in surgeries that require suturing or the placement of grafts, wherein the enhanced healing properties of PDRN can significantly elevate success rates. Lastly, the overall patient experience in dental care improves with PDRN treatments. Patients report feeling more satisfied with their treatment outcomes due to reduced discomfort and quicker recovery. The psychological impact of these benefits cannot be overlooked, as a better experience can alleviate dental anxiety and promote more proactive oral healthcare habits. Consequently, the integration of PDRN into dental practices not only improves clinical results but fosters a more comprehensive approach to patient well-being.  

Regulatory and Safety Considerations

The use of polydeoxyribonucleotide (PDRN) in dentistry has garnered attention due to its potential therapeutic benefits, particularly in tissue regeneration and repair. However, understanding the regulatory framework and safety profile surrounding this compound is crucial for both practitioners and patients. The regulatory status of PDRN varies across different regions, impacting its availability and clinical applications. In the United States, the Food and Drug Administration (FDA) has classified PDRN as a biological product. The FDA is tasked with ensuring that any such product is safe and effective for human use. As of now, PDRN is not yet approved by the FDA specifically for dental applications, although it is available in some regenerative medical contexts. Therefore, dental professionals must adhere to the current regulations and evaluate the necessity of obtaining informed consent when utilizing PDRN in their practice. In Europe, PDRN enjoys a more favorable regulatory status, as several products incorporating this compound have received approval for therapeutic use, particularly in wound healing and tissue repair. This approval is indicative of a growing recognition of PDRN’s safety and efficacy. Nevertheless, dental practitioners should remain vigilant and informed about regional regulations, which can evolve based on new clinical evidence and research. Regarding the safety profile, PDRN is generally well-tolerated; however, some side effects, such as injection site reactions or mild discomfort, have been reported. Contraindications for PDRN use may include hypersensitivity to its components or underlying conditions that predispose individuals to adverse reactions. Dentists must weigh the benefits of PDRN against potential risks while considering the patient’s overall health and specific dental needs.  

Future Directions for PDRN Research in Dentistry

As the field of dentistry continues to evolve, the potential applications of Polydeoxyribonucleotide (PDRN) are gaining increasing attention. Future research is likely to focus on several key areas that could enhance the therapeutic uses of PDRN in dental practice. One significant direction is the investigation of PDRN’s efficacy in different areas of oral surgery, including its role in improving healing processes after tooth extractions and periodontal surgeries. Current studies are examining various dosages and administration routes to optimize healing outcomes, which could lead to more standardized treatments involving PDRN. Furthermore, research may delve into the applications of PDRN in treating dental pulp diseases. Studies are being initiated to evaluate the compound’s regenerative properties in pulp cells, which could revolutionize endodontic treatments. By enhancing the vitality and regenerative capacity of these cells, PDRN could significantly improve patient outcomes in root canal therapies and potentially reduce the need for invasive procedures. The role of emerging technologies in enhancing PDRN’s effectiveness also warrants attention. For instance, combining PDRN with biomaterials such as hydrogels or scaffolding technologies may improve its local delivery and functional integration in bone and soft tissue regeneration. Exploring the synergy of PDRN with other regenerative agents could create multi-faceted approaches to complex dental issues. Moreover, as we learn more about the molecular mechanisms behind the benefits of PDRN, the prospective development of PDRN-impregnated dental materials could provide novel solutions for restorative dentistry. Investigating how these advancements intertwine with regenerative medicine principles promises to open new pathways for innovative dental therapies. In conclusion, the future of PDRN in dentistry is promising and multifaceted, offering numerous avenues for research. As studies progress and technological advances unfold, the integration of PDRN into dental treatments may significantly enhance patient care and outcomes.  

Challenges and Limitations of PDRN Application

The incorporation of Polydeoxyribonucleotide (PDRN) into dental practice is met with various challenges and limitations that may hinder its widespread acceptance and application. One significant hurdle is the cost associated with PDRN products, which can be prohibitively expensive for both practitioners and patients. Compared to traditional treatments, the financial burden of PDRN therapy may deter its use, particularly in socioeconomic settings where patients are relying on budget-friendly options. Availability is another pressing concern. While PDRN has shown promising applications in various areas of medicine, its supply in the dental field may be limited. The production and distribution of PDRN products require specific regulations and quality controls, which can slow down their entry into the market. This limited accessibility can create disparities in patient care, as dental practices in certain regions may not have the necessary resources or connections to obtain effective PDRN therapies. Public perception of novel treatments like PDRN can also present significant challenges. Patients may remain skeptical about the efficacy of PDRN, preferring well-established methods over newer alternatives that have not yet achieved broad acceptance in the general population. Educating patients about the benefits and safety of PDRN application is critical to overcoming this barrier. Finally, further research is essential to solidify the efficacy of PDRN across a wider range of dental treatments. Currently, the clinical evidence supporting PDRN’s use in dentistry is still emerging, and extensive studies are required to confirm its effectiveness in various procedures, such as periodontal therapies and oral surgery. In conclusion, while PDRN shows potential in enhancing dental practices, overcoming the challenges of cost, availability, public perception, and the need for more comprehensive research is vital to ensure its successful integration into mainstream dentistry.  

Conclusion: The Future of PDRN in Dental Medicine

As we explore the multifaceted role of PDRN (polydeoxyribonucleotide) in dentistry, it becomes clear that this innovative compound holds significant promise for transforming patient care. Throughout this discussion, we have examined various applications of PDRN, including its effectiveness in wound healing, tissue regeneration, and inflammatory response modulation. The strong regenerative properties of PDRN suggest it can facilitate recovery after dental procedures, contributing to improved patient outcomes and enhanced quality of care. The increasing body of research surrounding PDRN demonstrates its potential to address various challenges in dental medicine, from treating periodontal diseases to managing post-surgical complications. As dental practitioners continue to adopt these advancements, the application of PDRN could lead to the development of novel therapies that prioritize patient comfort and satisfaction. The future of PDRN in dentistry looks promising, with the potential for innovation in treatment protocols and enhanced healing times for patients. Looking ahead, it is crucial for continued research and clinical trials to validate the utility of PDRN, focusing on optimal dosages and delivery methods in dental applications. The integration of PDRN into standard dental practice may not only improve clinical efficacy but also pave the way for a paradigm shift in how dental health is approached. Collaboration between researchers, clinicians, and industry stakeholders will be essential to realize the full potential of PDRN. Ultimately, the advancements in PDRN are poised to revolutionize patient care in dentistry, making it a focal point in the pursuit of enhanced dental health and comprehensive treatment solutions.
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