Dental News - Interview: “Bioactive endodontics is the future”

Interview: “Bioactive endodontics is the future”

Monique Mehler, Dental Tribune International

Mon. 8. July 2019

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In the medical field, cryotherapy is used in an effort to relieve pain and swelling after soft-tissue management or surgery. Currently, researchers in the U.S. are exploring the possibilities and limitations of vital pulp cryotherapy in clinical trials. Dr. James Bahcall, who plays an important role in these investigations, is a clinical professor at the University of Illinois at Chicago. He spoke to Dental Tribune International about the studies.

Dr. Bahcall, in collaboration with other researchers, you have published an article titled “Introduction to vital pulp cryotherapy” in which the use of cold therapy in endodontics is explored. What is the history behind the use of cryotherapy in vital pulp therapy?
There has been a paradigm shift in vital pulp therapy over the last three to five years. We have gained a better understanding of pulp biology from caries involvement, and there have been new developments in bioceramic materials. We have also come to view vital pulp therapy as a permanent rather than temporary dental treatment. All of this allowed us to develop vital pulp cryotherapy. Although we did not invent cryotherapy, we were the first to bring it into endodontics for vital pulp treatment. Medicine has demonstrated since the early 1960s that cryotherapy can reduce nerve pain response, inflammation and hemorrhaging, and can help reduce a patient’s need for postoperative pain medications.

Vital pulp cryotherapy is performed when a carious lesion is removed from a tooth and there is direct or indirect exposure of the dental pulp. The cryotherapy portion of treatment involves placing sterile ice on the exposed pulp. The application of ice lowers the temperature of the tooth’s blood and nerve supply, and this has been shown clinically to reduce inflammation and post-treatment tooth pain. It is important to note that, after performing the cryotherapy procedure, 17% EDTA irrigation is applied, a bioceramic material is then placed over the directly or indirectly exposed pulp, and the tooth is restored with a permanent restorative material, such as composite or amalgam.

How is this different from classic root canal therapy?
Vital pulp cryotherapy involves treating a carious tooth while maintaining the tooth’s pulpal tissue as opposed to root canal therapy that involves removal of the entire dental pulp and replacing it with gutta-percha and sealer.

What are the benefits of vital pulp cryotherapy, and what are its limitations?
The benefits of vital pulp cryotherapy are its ability to eliminate pulpal inflammation and a patient’s tooth pain without the complete removal of the dental pulp. By maintaining the dental pulp, we are able to maintain the tooth’s strength by not having to remove root dentin, the pulp–dentin complex and the pulp’s immune defense mechanisms. Another benefit of vital pulp cryotherapy is the treatment time for the patient. Once the patient is properly anesthetized and the caries is removed, the actual time to complete the vital pulp cryotherapy portion is 10–15 minutes. In comparison, root canal therapy can take 1–2 hours. Vital pulp therapy procedures are completed in one patient treatment visit.

The limitation of vital pulp cryotherapy is that this procedure can only be performed on vital teeth that can be permanently restored with composite or amalgam immediately after the procedure. It cannot be performed with necrotic or partially necrotic pulps. A clinician cannot prepare a vital pulp cryotherapy treated tooth for a crown. The reason for this is that, once the vital pulp cryotherapy is completed, you do not want to do any further dental treatment to this tooth because you risk the possibility of restimulating the pulpal inflammation.

In your article, you conclude that further clinical studies are needed in order to establish the long-term prognosis of a pulp after vital pulp cryotherapy. What are your expectations?
As with any new dental procedure, clinical cases and studies need to be published in peer-reviewed dental literature. Vital pulp cryotherapy is no different. We have published case reports and have been conducting clinical research on vital pulp cryotherapy. Our study has found that patients have less postoperative pain immediately after treatment and maintain normal pulp vitality at six months and at one year after treatment. This is as far as our clinical study has patient recalls at this point. Our expectations are, firstly, to demonstrate that this is a valid procedure for vital pulp treatment beyond one year. Secondly, we hope to encourage our dental colleagues to publish vital pulp cryotherapy case reports and clinical research in the dental literature.

How do you think vital pulp cryotherapy will advance endodontics?
We feel that vital pulp cryotherapy will help to broaden the type of pulpal treatment that we can provide to our patients. It also will be an important treatment component in bioactive endodontic therapy. Bioactive endodontics is the future. By definition, “bioactive” means having a biological effect. Bioactive endodontics in conventional endodontic treatment includes vital pulp cryotherapy and regenerative endodontics. It involves the use of bioactive materials and the patient’s own blood to help heal, as in the case of vital pulp cryotherapy, and to replace the gutta-percha and sealer in classic root canal therapy.

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SEOUL, South Korea: Osstem Implant has obtained certification under Regulation (EU) 2017/745 (Medical Device Regulation) for a portfolio of 4,695 implant and medical device products. The certification confirms that Osstem’s quality management system meets international standards and supports confidence among European clinicians in the reliability and regulatory oversight of the certified products. The scope of certification covers dental devices widely used in clinical practice, including Class I reusable surgical instruments and kits, Class IIa reusable and single-use dental instruments, and Class IIb implantable devices.

The EU has fundamentally strengthened its regulatory framework by transitioning to the Medical Device Regulation (MDR). MDR requires enhanced clinical evidence through continuous clinical evaluation, mandates post-market surveillance and post-market clinical follow-up, and integrates risk management and quality management systems across the entire product life cycle. It also increases the rigour and frequency of audits by independent notified bodies and improves device traceability and transparency via unique device identification and the European Database on Medical Devices (EUDAMED). Collectively, the MDR certification process demonstrates that Osstem’s products meet the safety and performance requirements of the strengthened EU regulations.

The certified portfolio includes Osstem’s KS and TS flagship implant systems, as well as prosthetic components, orthodontic screws and titanium membranes. The KS system adopts a single platform to enhance workflow convenience in surgical and prosthetic procedures and to improve fatigue strength. The TS system delivers strong primary stability and long-term reliability across diverse clinical cases. The availability of multiple Osstem implant surface treatments—such as SA (sand-blasted and acid-etched), CA (calcium-treated), BA (bioabsorbable apatite), SOI (Super OsseoIntegration) and RBM (roughened by resorbable blasting media)—enables clinicians to tailor treatment strategies to their clinical preferences and the patient.

Key products that have obtained MDR certification have been significantly improved with the goals of enhancing user convenience and procedural safety and expanding market competitiveness. The specialised sinus lift kit, the CAS KIT, enhances user convenience by incorporating a short drill alongside the standard CAS KIT specifications, and the design of the membrane lifter has been changed to a wing-like structure, offering superior sealing performance that significantly reduces the possibility of membrane perforation.

Furthermore, the One485 KIT, OnePositioning KIT and OneGuide KIT (Short) received MDR certification. The One485 KIT is a guided surgery kit dedicated to Osstem’s unique short implant line-up (4.0–8.5 mm), which allows for implant placement without bone grafting in cases of limited residual bone. The OnePositioning KIT determines the precise implant placement and direction, enhancing the accuracy and convenience of guided surgery. The OneGuide KIT(Short) is a guided surgery kit for patients with limited vertical space, such as in the mandibular posterior region, and incorporates short drills to accommodate reduced clearance.

The portfolio of link abutments has been greatly diversified. An open type has been added alongside the existing closed type, as well as four gingival height options (1, 2, 3 and 4 mm), resulting in a total of 48 specifications. The addition of the open type, in particular, enables aesthetic procedures in highly visible areas, such as the maxillary anterior region, while compatibility with existing implant-level scan bodies streamlines the workflow and reduces additional component costs.

In addition, the TS transfer abutment and GBR cover screw obtained MDR certification. Owing to a change in raw material to titanium, the TS transfer abutment now has improved screw loosening resistance and screw strength, and the GBR cover screw was redesigned into a dome shape to maintain the guided bone regeneration space.

This new achievement for Osstem follows MDR certification in August 2024 for 156 products, including surgical kits and guided surgery solutions. The first and second certification phases having been completed, all products manufactured at Osstem’s production centre in Busan in South Korea now comply with MDR, further validating the company’s manufacturing and quality assurance capabilities. Osstem plans to complete MDR certification for its bone grafting materials, products manufactured outside Busan and new products by next year.

A company spokesperson said, “The MDR certification demonstrates that our quality and clinical standards meet the strengthened EU regulations. We will continue to collaborate with European clinicians to deliver MDR‑compliant, reliable solutions that improve patient outcomes and enhance global trust in our brand.”

The certificate was issued by TÜV Rheinland LGA Products (notified body No. 0197). The certificate number is HZ 2292034-1, and the EUDAMED single registration number is KR-MF-000020006. Osstem’s EU authorised representative is Obelis in Brussels in Belgium.