|
|
|
|
|
|
|
|
|
| The turbulent two-phase flow
process invented by Novaflux was developed
to solve two main problems in the dental field, namely: removal/cleaning
and eradication of biofilm from dental unit waterlines and reprocessing/decontamination
of high-speed dental handpiece at low temperature -- less than 50°C.
It is no longer a day and age when we can be satisfied with substandard
cleaning and reprocessing procedures in dentistry or medicine. Slimy biofilm is the cause of the unacceptably high microbial contamination of dental water supply. The heavy contamination of dental treatment water is due to biofilm growing in the lumen of dental unit waterlines, and is normally referred to as the “dentist’s little dirty secret.” The typical dental treatment water used during dental treatment in the United States may contain in excess of one million colony-forming units per milliliter (CFU/ml). This contamination is actually due to shedding of organisms from the established biofilm growing on the lumen surface of dental unit waterlines. Dental unit biofilm has been found to amplify a number of pathogens such as Leginella sp. and other species. Leaving this problem without a solution is not acceptable according to current asepsis techniques of modern dentistry. A major health concern is the prevalence of large biofilm fragments in dental water supply that may introduce infection if aspirated into lung, ingested by patients or become incorporated in oral tissue during dental treatment. This form of exposure is expected to be dangerous to those with compromised immune system including the young and elderly persons since the immune system is not effective in combating organisms delivered as biofilm fragments. The ultimate solution of this serious problem lies in the removal and eradication of biofilm along with its polysaccharide matrix from dental unit waterlines and in preventing its formation in the complex waterline circuits. Once the biofilm is removed the source of the problem is eliminated. Routine flushing of dental waterlines or employing disinfection regimens may only provide partial and temporary solutions at best. The two-phase cleaning process patented by Novaflux provides a solution to the dental unit biofilm problem with an emphatic yes. Our technology quickly and efficiently removes all dirty biofilm and its polysaccharide matrix from dental unit waterlines and thus provides a cardinal solution to the problem. The Novaflux device can be installed in the dental chair and performs biofilm removal from all waterlines and circuits with only a push of a button. The Novaflux device can run on automated cycle at convenient set schedules without time consumption of dental professionals, and thus ensuring compliance. Our system is installed once in the dental chair and daily cleaning is recommended. The cycle requires only 14 minutes to perform with only minimal input from the dental professional. Our technology was clinically proven with the support of major grants from United States Air Force, National Institutes of Health and the New Jersey Commission on Science and Technology. The University of Maryland Dental School at Baltimore (UMAB) was the site for the clinical trial to validate the effectiveness of the Novaflux dental waterlines device in actual clinical setting. Including setup and testing, the trial ran for approximately 12 months with a total of 10 dental chairs in two clinics. Professor Henry Williams was the PI of the study at UMAB Dental School. The device itself was designed and built by Novaflux engineers, and then installed with the help of dental unit technicians from UMAB. The average installation time was approximately 4 hours, and could be decreased to three hours, if the work is done by trained service technicians. The dental chair used in the study was an Adec chair, modified for dental student training purposes. The Novaflux device was installed to clean waterlines supplying water to the high-speed handpiece, dentist syringe and assistant syringe. Some modifications in the chair were made to clean the control block and other complex parts of the waterline circuit. Novaflux Technologies has concluded the development of the device and protocols to remove biofilm from the entire dental unit circuit. The Novaflux solution is practical and ensures compliance of dental professionals in maintaining their units in acceptable condition without complications from biofilm. The operation of the device was carried out by graduate students and technicians of UMAB Dental School. A 750-milliliter cleaning solution bottle was sufficient to provide the cleaning solution needed to make the turbulent two-phase flow mixture for a period of one month. Cleaning the unit once per day during weekdays was sufficient to maintain the bacterial level below the 200 CFU/ml limit recommended by ADA with NO biofilm accumulation or growth in the lumen of dental unit waterlines, as validated by protocols developed by Professor Henry Williams. The clinical study was instrumental in identifying and perfecting the design of a final device to eradicate biofilm and control bacterial contamination of dental unit waterlines. The major lesson that we have learned from the study was if even a small length, ca 1/8 of an inch, of dental waterlines is left without cleaning, controlling the quality of dental water supply is compromised. We are in the process of compiling data and information for the 510(k) submission to the FDA. Our system is the only validated system that is capable of removing biofilm from dental unit waterlines, including dental units that use municipal water as the main source for dental water supply. The high-speed handpiece is considered the most important device in modern dentistry. Current thermal methodologies used to sterilize handpieces have been found to decrease the operational efficiency and cause catastrophic failure of the high-speed turbine. One major cause for such failure is due to the thermal fatigue of epoxy-resin retainer that holds the bearing during high-speed rotation. Another cause of failure and loss of efficiency of the high-speed handpiece is attributed to the lack of cleaning its interior surfaces, especially from the lubricant that is continually being baked on with repeated autoclaving. Frequent repair of high-speed handpieces is a major cost to dental practice in the United States. The industry demands a new technology to clean and decontaminate the handpiece at low temperatures. Novaflux Technologies is developing a solution to this problem using its highly effective cleaning method of narrow channels by incorporating into a system that would provide decontamination of dental handpiece to level equivalent to thermal autoclaving but at much lower temperature. We are in the process of validating a device and protocol for this application as part of our NIH funded research. The Novaflux reprocessing device performs the cleaning of all internal channels of high-speed dental handpiece, including the very narrow air and water channels. This automated device is programmed to achieve cleaning, rinsing, exposure to an FDA approved liquid sterilant and drying at the end of the cycle. We are perfecting the device so that the handpiece can be removed without contamination using a novel sterile pouch system. Diverse microorganisms will be used in the study to validate equivalence to conventional thermal methodologies. |
|
|
|
|
|
|
|
|
|
| The Novaflux cleaning process offers a cardinal solution to removing and eradicating biofilm from dental unit waterlines and offers a safe method to reprocess the high-speed handpiece at low temperature to replace harsh thermal methodologies currently used. It is no longer a day and age when we can be satisfied with substandard cleaning and reprocessing procedures in the dental field. The two-phase cleaning process patented by Novaflux answers the need to remove biofilm and adhering contaminants from dental unit waterlines and high-speed handpiece with an emphatic yes. Our technology quickly and efficiently removes biofilm and its matrix and other harmful organisms for the narrow lumen of dental unit waterlines and internal channels of high-speed handpiece. The dental unit waterline cleaning device is installed in the dental chair and performs a daily cleaning cycle with the push of a button. The clinical study performed at the UMAB dental school has proved the utility of the technology in eradicating biofilm from dental unit waterlines and in controlling the bacterial count below the 200 CFU/ml level recommended by ADA. The device in installed once and the cycle required about 10 minutes to complete with minimal attention from the dental professional. Since the Novaflux technology removes the biofilm from the lumens of dental unit waterlines it offers the needed solution to solve this major contamination problem. This site provides picture and description of the Novaflux device in actual dental chairs. The device is designed to retrofit existing dental chair, or can be integrated into the design of new dental units. |
| The following is the schematic of a typical dental unit fluid circuit with and without the Novaflux waterlines cleaning device. The device is programmed to clean and rinse the different waterlines of dental units made by different manufacturers. The chemical formulation used to form the two-phase flow cleaning is safe and effective in removing dental unit biofilm. The technology can also perform biofilm removal and disinfection of waterlines at the same time. |
 |
|
|
|
|
| Back to Novaflux home |
