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

Interview: “Bioactive endodontics is the future”

Dr. James Bahcall and colleagues are exploring the possibilities of cryotherapy in endodontic dentistry. (Photograph: Dr. James Bahcall)

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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NONTHABURI, Thailand: The Thai Food and Drug Administration (FDA) has simplified the technical documentation required for custom-made dental devices made for individual patients in Thailand or imported into the country. The change, announced in April, applies to devices classified as risk Classes 2–4 and is intended to reduce the documentation burden for manufacturers and importers.

According to regulatory consultancy Qualtech, manufacturers or importers previously had to submit full finished-product test reports for every individual custom-made device. Under the revised approach, this will no longer be required for devices made from materials that are commonly used in dental practice and have an established history of use, provided that certain requirements are met. The defined list of materials includes dental ceramics, such as zirconia, lithium disilicate, feldspathic ceramics in powder form and hybrid ceramics; dental alloys, including titanium alloy, cobalt–chromium alloy, austenitic alloys, palladium alloy and stainless steel; and dental polymers, including PMMA, PEMA, hybrid polymer resin and polycarbonate resin.

For devices manufactured from these materials, manufacturers or importers must submit raw-material documentation as part of the technical evidence supporting the application. This may include evidence of raw-material approval or clearance by a foreign regulatory authority, a material safety data sheet or a certificate of analysis. Manufacturers or importers must also declare and certify that the device is produced from raw materials with a long history of use, that no novel manufacturing process is employed and that the process used to make the final device does not affect the safety or performance of the material. The revised pathway therefore gives greater weight to the materials from which custom-made dental devices are produced and brings submission requirements more closely into line with established dental manufacturing practices.

Part of a wider regulatory debate

The Thai FDA’s approach comes amid wider discussion about how medical device regulation can maintain patient safety and avoid disproportionate documentation requirements for manufacturers. In Europe, manufacturers and industry associations have recently called for changes to Regulation (EU) 2017/745, the EU medical device regulation, arguing that some requirements place a heavy burden on producers of long-established medical and dental devices. The Thai FDA’s revised pathway offers one example of a more targeted approach for custom-made dental devices produced from established materials.