symposium Stanley F. Malamed, D.D.S. Chairman Sponsored by Milestone Scientific

Th e 1 s t A n n ua l I n t e r nat i o na l C O M P U T E R - C O N T R O L L E D L O C A L A N E S T H E T I C D E L I V E R Y symposium 2008 Stanley F. Malamed, D.D.S. Chairman Sponsored by Milestone Scientific

CLINICAL SUMMARY On February 8-10, 2008, the First International Computer-Controlled Local Anesthetic Delivery (C-CLAD) Symposium was held at The Ritz-Carlton, New Orleans, Louisiana. Stanley Malamed, DDS, Professor of Anesthesia and Medicine at the University of Southern California, Los Angeles, served as Chair for the symposium, and attendees included representatives from family and cosmetic dentistry, oral surgery, periodontics, endodontics, dental technology and surgical sciences (see Attendee List in Table of Contents). The goal of the C-CLAD Symposium was to provide a forum for discussion in the scientific and clinical practice communities toward the common goal of advancing the science, knowledge and clinical utility of C-CLAD in dentistry. The Symposium included presentations of clinical trials and testimony on clinical experience with C-CLAD technology (most notably the new [STA ] instrument) along with discussion of C-CLAD adoption in dental school curricula. The following is a summary report of the two-day C-CLAD Symposium, including clinical presentations, slides, quotes and conclusions. THE MOST NOTABLE UNANIMOUS CONCLUSIONS FROM THE C-CLAD SYMPOSIUM WERE: Consensus agreement that C-CLAD is the best way to administer a Palatal Injection and Intraligamentary Injection Consensus agreement that C-CLAD is the instrument of choice to minimize Pain Disruptive Behavior C-CLAD should become the standard of care when it comes to administering anesthesia

TABLE OF CONTENTS A State-of-the-State Review of C-CLAD Systems Stanley Malamed, DDS Update on the STA System for Dental Applications Mark Hochman, DDS Computer-Controlled Versus Conventional Syringe Delivery: Results of a Randomized Cross-Over Clinical Trial Peter Loomer, DDS, PhD Anesthetic Efficacy of Articaine and Lidocaine in Primary Intraligamentary Injection Administered With a C-CLAD System Alfred Reader, DDS, MS The Role of Epinephrine in Combination With Articaine 4% in Local Anesthesia Monika Daubländer, MD, DDS Video Monitoring of Aspiration With Five Injection Systems in an In Vitro Model Monica Daubländer, MS, DDS 2 3 4 5 6 6 Before you are a leader, success is all about growing yourself.when you become a leader, success is all about growing others. ~ JACK WELCH Insights on C-CLAD Systems: My Clinical Journey for Improved Local Anesthesia John Brescia, DDS, PC Insights from Private Practice William Lieberman, DDS, MBA STA Insights Martin Jablow, DMD 7 7 8 The 1 st Annual International C-CLAD Symposium 2008 page 1

So, my perspective is, again, any injection you do as a dentist where you have a higher pain score for patients, consider using these instruments. Whether it s the STA or any other instrument on the market you know, they re usable, their valuable. A State-of-the-State Review of C-CLAD Systems Stanley Malamed, DDS Dr. Malamed provided a review of C-CLAD systems. He began by providing statistics regarding the prevalence of patient fear of dental visits, primarily based on fear of injections, frequently triggered by the sight of the needle. Public Speaking Going to the dentist Our most common fears Heights Mice Flying Other/no fears 75% of medical emergencies (in dental offices) are related to stress and anxiety (fear & pain) Dr. Malamed stressed that addressing patient fear is vital, as medical emergencies, including syncope, seizure, angina pectoris and acute asthma, can result in the dentist office due to patient stress and fear. He also indicated that local anesthetics such as articaine, lidocaine, mepivacaine, prilocaine, and bupivacaine are the safest and most effective drugs in medicine for preventing and controlling pain. Dr. Malamed then reviewed the many tools (past and present) dentists have used to reduce patient stress and fear, including hypnosis, acupuncture, high-pressure transdermal systems, electronic dental anesthesia, and most recently, and most effectively, C-CLAD systems. The first C-CLAD system, The Wand, was introduced in 1997, followed by the Comfort Control system, QuickSleeper, CompuDent, CompuMed, and lastly, the STA instrument. Dr. Malamed emphasized that administering palatal injections with a C-CLAD instrument could be painless and that the number of competing C-CLAD instruments attests to the importance of this technology and its benefit to the patient. STANLEY F. MALAMED, D.D.S. Doctor Malamed was born and raised in the Bronx, New York, graduating from the New York University College of Dentistry in 1969. He then completed a dental internship and residency in anesthesiology at Montefiore Hospital and Medical Center in the Bronx, New York before serving for 2 years in the U.S. Army Dental Corps at Ft. Knox, Kentucky. In 1973, Doctor Malamed joined the faculty of the University of Southern California School of Dentistry, in Los Angeles, where today he is Professor of Anesthesia & Medicine. Dr. Malamed is a Diplomate of the American Dental Board of Anesthesiology, as well as a recipient of the Heidebrink Award [1996] from the American Dental Society of Anesthesiology and the Horace Wells Award from the International Federation of Dental Anesthesia Societies, 1997 (IFDAS). Doctor Malamed has authored more than 135 scientific papers and 17 chapters in various medical and dental journals and textbooks in the areas of physical evaluation, emergency medicine, local anesthesia, sedation and general anesthesia. In addition, Dr. Malamed is the author of three widely used textbooks, published by CV Mosby: Handbook of Medical Emergencies in the Dental Office (6th edition 2007); Handbook of Local Anesthesia (5th edition 2004); and Sedation - a guide to patient management (4th edition 2003) and two interactive DVD s: Emergency Medicine (2nd edition, 2008) and Malamed s Local Anesthetic Technique DVD (2004). In his spare time, Doctor Malamed is an avid runner, exercise enthusiast, and admits an addiction to the New York Times crossword puzzle, which he has done daily since his freshman year in dental school. The 1 st Annual International C-CLAD Symposium 2008 page 2

Update on the STA System for Dental Applications Mark Hochman, DDS Dr. Hochman stated that C-CLAD instruments substantially reduce pain-disruptive behavior in the pediatric population, and consequently, is becoming the standard of care. Additionally, Dr. Hochman noted that he and his colleagues demonstrated for the first time that there were no adverse histological changes following Intraligamentary injections with a C-CLAD system. Dr. Hochman presented an update on the STA System, including a review of the dynamic pressure sensing data and an explanation of refinements that have been made to the STA instrument. He described the features of STA in detail: guidance to target location, identification of specific tissue, continuous audible and visual feedback, occlusion and leakage indicators, along with rapid onset and longer duration of anesthesia. The Benefits of the STA System Rapid On-set Get right to work no waiting Longer Duration Because you re delivering increased volume Comfort No droopy-lip-syndrome & No numb tongue And...it s more comfortable then the traditional dental syringe The FIRST Primary, Predictable PDL Dr. Hochman stated that the core technology of the STA instrument comprises precision fluid and needle control, and that the unique features of the STA include product simplification, plug-and-play functionality, automated features, an innovative training mode, and an improved hand piece. He discussed how the STA-Wand hand-piece has been re-engineered for the STA System and optimized for the intraligamentary injection. The STA System was designed to allow dentist to perform the desirable Intraligamentary [PDL] injection as a predictable, primary dental injection replacing the need to perform an Inferior Alveolar block for single tooth anesthesia. The STA System has a variety of new modes to allow every injection currently used in dentistry to be performed more easily (with additional benefits) for both the dentist and the patient. Dr. Hochman concluded by reviewing the benefits of the STA System: ease of use, ability to perform all traditional injections, new STA intraligamentary injection, comfort (no tongue or lip numbness), virtually painless injections, and real-time dynamic pressure-sensing feedback. The Rationale for the STA System Guidance STA helps you identify the proper area to deliver Identification STA identifies specific tissue ideal for Intraligamentary (PDL) tissue Continuous Feedback During the injection Visual & Audio ensuring 100% confidence Dr Mark Hochman is a multi-trained specialist in Periodontics, Implant Dentistry and Orthodontics. He is currently an Associate Clinical Professor at New York University College of Dentistry. He is a team member of the New York Center for Specialized Dentistry, an interdisciplinary team practice composed of specialist providing comprehensive dental care in New York City. He has contributed to the dental literature on a variety of topics. Dr. Hochman serves as Director of Clinical Affairs and Director of Research and Development for Milestone Scientific, Inc. since 1999. He is recognized as a world authority on advanced drug delivery systems in dentistry and medicine. Dr. Hochman invented and has participated in the development of much the technology currently available from Milestone including the STA System. The 1 st Annual International C-CLAD Symposium 2008 page 3

Computer-Controlled Versus Conventional Syringe Delivery: Results of a Randomized Cross-Over Clinical Trial Peter Loomer, DDS, PhD Dr. Loomer presented the results of a clinical trial examining patients pain experience (N=20; 10 men, 10 women) with conventional syringe delivery of anesthesia vs a C-CLAD instrument (The Wand ). The study also examined the efficacy of the two anesthetic systems, as well as pain experience differences between male and female subjects. Each subject had four appointments, where he or she underwent scaling and root planing with 2% lidocaine (mandibular and maxillary arch injections). Each subject served as his or her own control (ie, half mouth used for each system). A visual analog scale (100-mm line) and verbal rating scale (VRS; 0-4 scale comprising none, mild, moderate, severe, and very severe) were used to measure pain, and were recorded for each injection. Subjects were followed up by telephone to answer a set of questions (including subject preference). Each subject received a total of 11 injections (four with The Wand and seven with the syringe). Results showed that the two techniques were equally effective at providing anesthesia (as measured by bleeding upon probing and effective periodontal outcomes) and that use of The Wand resulted in lower VAS and VRS scores than the syringe. Statistical significance favored The Wand for anterior middle superior alveolar (AMSA) injections compared with the combined maxillary injections (maxillary-amsa) and nasopalatine (NP) injections (NP-AMSA) as assessed by VAS (Table 1; values are the mean differences in scores between techniques). Additionally, AMSA VRS scores were significantly lower than the VRS scores for greater palatine and combined maxillary injections; patients preferred The Wand over the syringe; and women reported higher VAS and VRS scores than men. Interestingly, the study also showed that administration of the two techniques took the same amount of time, negating concerns that use of The Wand takes too long. VAS Comparisons COMPARISON OF VISUAL ANALOG SCALE RESULTS. CONVENTIONAL SYRINGE DELIVERY VERSUS COMPUTER- CONTROLLED DELIVERY N MEAN VISUAL ANALOG SCALE SCORE +_ STANDARD DEVIATION P VALUE PSA-PSA 18 3.9 +_ 19.8.229 IA-IA 20 4.6 +_ 18.6.297 LB-LB 20 5.9 +_ 13.6.085 ASA-AMSA 19 15.4 +_ 29.9.060 MSA-AMSA 19 1.5 +_ 21.7.806 GP-AMSA 19 24.9 +_ 29.4.060 NP-AMSA 19 17.3 +_ 26.9.008 Maxillary-AMSA 19 30.3 +_ 28.3 <.0001* PSA: Posterior superior alveolar; IA: inferior alveolar; LB: long buccal; ASA: anterior superior alveolar; AMSA: anterior middle superior alveolar; MSA: middle superior alveolar; GP: greater palantine; NP: nasopalantine. *Highly statistically significant. Peter Loomer, DDS, PhD, is an Associate Professor of Clinical Periodontology and the Director of Clinical Affairs, Division of Periodontology, Department of Orofacial Sciences, UCSF School of Dentistry. He is a Diplomate of the American Board of Periodontology. Dr. Loomer maintains a private practice limited to periodontology at UCSF. He conducts both clinical and laboratory research in periodontology, pain and implant dentistry, is widely published and lectures on the local and national levels. The 1 st Annual International C-CLAD Symposium 2008 page 4

Anesthetic Efficacy of Articaine and Lidocaine in Primary Intraligamentary Injection Administered With a C-CLAD System Alfred Reader, DDS, MS C-CLAD causes less pain on injection, why wouldn t you use it? It s just that simple. Dr. Reader presented the results of a prospective, randomized, double-blind study (N=51 adult subjects) that compared the anesthetic efficacy (by Kerr Electric Pulp Tester) and effect on heart rate (by pulse oximeter during five periods) of articaine 4% plus epinephrine 1:100,000 vs lidocaine 2% with epinephrine 1:100,000 given via intraligamentary injection in the mandibular first molar using C-CLAD (Wand Plus system). In a crossover fashion patients received 1.4 ml injections of articaine and lidocaine spaced two weeks apart. Study results showed no significant differences in anesthetic success rate (86% vs 74%, P=0.176), anesthetic duration (34 vs 31 min, P=0.333), or heart rate (72-74 vs 72-74 bpm) between articaine and lidocaine. Duration of anesthesia was increased with C-CLAD in comparison with standard methods (comparison with literature; not a study endpoint). Dr. Al Reader is currently a Professor and Program Director of Advanced Endodontics at The Ohio State University. He received his DDS degree, endodontic training, and Masters Degree from Ohio State. Currently he is a Director of the American Board of Endodontics and has published in the area of local anesthesia and endodontics. Conclusions We concluded that the intraligamentary injection, using the Wand Plus System, of 4% articaine with 1:100,000 epinephrine and 2% lidocaine with 1:100,000 epinephrine were not significantly different with regard to anesthetic success and anesthetic duration. Duration was increased with C-CLAD over standard methods. neither anesthetic formulation produced significant increases in heart rate during or following the injection of 1.4 ml of solution. % 80/80 Results Mandibular First Molar Certainly the palatal injection is less painful with the C-CLAD and you don t have to blanch the whole [maxillary palate]. Time (minutes) The 1 st Annual International C-CLAD Symposium 2008 page 5

The Role of Epinephrine in Combination With Articaine 4% in Local Anesthesia Monika Daubländer, MD, DDS Video Monitoring of Aspiration With 5 Injection Systems in an In Vitro Model Monica Daubländer, MS, DDS Dr. Daubländer began her presentation by stating that articaine was administered in more than 90% of dental anesthesias in Germany. She then presented a series of studies involving male baboons and examining the safety of articaine used in combination with different concentrations of epinephrine. In the first study, articaine administered intravenously (IV) to male baboons decreased systolic blood pressure and increased cerebral blood flow without altering regulatory mechanisms. As expected, the addition of vasoconstrictors epinephrine or norepinephrine to articaine IV increased systolic blood pressure. However, epinephrine at various concentrations (1:100,000, 1:200,000, 1:400,000) decreased the articaine-induced increase in cerebral blood flow in a dose-dependent manner. Subsequent studies in baboons with infiltration anesthesia determined that epinephrine at a concentration of either 1:300,000 or 1:400,000 optimally reduced plasma levels of articaine and lowered the increase in cerebral blood flow. Finally, in studies conducted in healthy volunteers, Dr. Daubländer indicated that only 50% of volunteers were adequately anesthetized when articaine alone was administered to the maxillary front teeth via infiltration. However, articaine plus epinephrine induced anesthesia in all volunteers, the duration of anesthesia being a function of the dose of articaine (Figure 1). Infiltration (Maxillary Front Teeth) Dr. Daubländer, also presented the results of a study comparing involuntary needle movement during aspiration among several types of syringes and The Wand. She reviewed the safety issues surrounding involuntary needle movement, including aberrance of needle position, risk of intravasal injection, risk of pain, and risk of soft tissue trauma. The injections were performed on an in vitro model, and involuntary movements were captured on video and plotted to determine the degree of movement. The study concluded that movement during aspiration is unavoidable, but that there were statistically significant differences between the degree of movement with The Wand compared with that of the different syringes. The movement produced with the use of the syringes was found to be two-to three-fold higher compared with The Wand (Figure 2). Amount and Correlation of Deviation Scatter Plot Pearson correlation coefficient r= 0.281 Video monitoring of aspiration with five injection systems in a In Vitro Model Monika Daubländer, MD, DDS Deviation 2 (mm) Deviation 1 (mm) Intensity of electric stimulation Mean Deviation (mm) 2ml 5ml Disc Thumb Wand ring Medical Education: University of Mainz/Germany University of Berne/Switzerland Time (min) Dental education: University of Mainz/Germany Consultant Oral Surgeon and Lecturer in Oral Surgery, local anaesthesia and pain management in Dentistry Associate Professor Clinic of Oral Surgery University of Mainz/Germany The 1 st Annual International C-CLAD Symposium 2008 page 6

Insights on C-CLAD Systems: My Clinical Journey for Improved Local Anesthesia John Brescia, DDS, PC T H E P R A C T I T I O N E R John Brescia, DDS, PC, described the many benefits experienced in his practice (for both the practitioner and patient) of C-CLAD. He cited reduced patient stress and enhanced comfort due to the accuracy of the instrument and its minimally invasive injections. He noted that operator stress was also reduced due to efficient anesthesia and ergonomics. The choice of automatic or manual aspiration, absence of collateral paresthesia, and ability to load a second cartridge were all mentioned as operator benefits. Dr. Brescia added that the use of the STA instrument had increased his patient referrals. The total time of any procedure is decreased, I found, using The Wand because the anesthesia, the onset was quicker. It was more profound when I needed it where I needed it, and since they re not apprehensive, I m not apprehensive, and I m much more efficient in how I m doing my procedure. I get very good blocks with good onset, or better than I ever did with the syringe. Why Choose C-CLAD? I.E. STA, The Wand Presentation: Patients are more at ease with the appearance of C-CLAD as opposed to conventional syringe. Accuracy: Due to minimizing needle deflection by ergonomic design, reduction of vector force. Patient Comfort: Clinically proven computer controlled rate of flow and pressure. Aspiration: Automatic or on-demand. Versatility: Single tooth, multiple tooth injections that are minimally invasive using small diameter needles. Relieves Patient Stress: The Wand is far less threatening visually to a patient. Reduced Operator Stress: Due to efficient anesthesia and ergonomics. Productivity: Faster onset I get right to the procedure. Patient Referrals: I ve turned the injection into a positive experience. John Brescia D.D.S. a graduate of the Chicago College of Dental Surgery, Loyola University Medical Center, has practiced family and cosmetic dentistry in the Oak Park-River Forest suburb of Chicago for the past 29 years. He is a former pre-clinic instructor at Loyola University School of Dentistry, Maywood Illinois. Dr. Brescia has lectured extensively on radiosurgery. He has also worked on product development and anesthesia technique. He served on the Advisory Committee for the Richmond Institute for Continuing Dental Education. Most recently Dr. Brescia wrote the forward to the textbook, Oral Radiosurgery An Illustrated Clinical Guide 3rd Ed. Insights From Private Practice William Lieberman, DDS, MBA William Lieberman, DDS, MBA, shared his clinical experience (pediatric dentistry Red Bank & Colts Neck NJ) with C-CLAD systems. His introduction to C-CLAD was The Wand, which replaced the use of syringes entirely in his office. He recently purchased the STA instrument and has been pleased with it. He noted that lip biting from lip anesthesia, a major postprocedural problem with pediatric patients, is eliminated with use of STA. Dr. Lieberman also shared anecdotal stories of pediatric patients who were satisfied with STA anesthesia; he stated that the use of STA is helpful in minimizing William H. Lieberman, D.D.S., M.B.A., is a graduate of Temple University and served as the president of the American Society of Dentistry for Children and as a trustee for the American Association of Pediatric Dentistry. Dr. Lieberman also teaches at NYU College of Dental Medicine and Monmouth Medical Center. disruptive behavior [caused by stress and fear] in the pediatric patient because they don t even know they re getting it. He noted a need for guidelines regarding rubber dam clamp anesthesia, and more experience in administering anesthesia in maxillary teeth with regard to STA vs. infiltration. minimizing disruptive behavior [caused by stress and fear] in the pediatric patient because they don t even know they re getting it. The 1 st Annual International C-CLAD Symposium 2008 page 7

What you are going to get is quick profound anesthesia on the mandible. It lets me go straight to work without waiting 10 or 15 minutes, to see if I got profound anesthesia. T H E P R A C T I T I O N E R STA Insights Martin Jablow, DMD Martin Jablow, DMD, summed up his clinical experience with the STA system by saying I m not going back (to hand-held syringes). He stated that he has not received a single patient complaint regarding STA, and that use of the instrument has led to increased referrals. He cited patient comfort, STA safety, ability to initiate treatment immediately after STA, absence of patient discomfort postprocedure (ie, swollen/numb lips), and reduced number of needle sticks for certain procedures as the reasons for patient satisfaction with STA. A discussion followed Dr. Jablow s presentation during which the panel added their insight and experience regarding the use of the STA instrument. The panel was in accordance with Dr. Jablow s positive experience. Some panel members cited unlimited use of the instrument in their practices, because it lends itself to every injection technique. This was echoed by others: We ve been using STA on every tooth from four bicuspid extractions to restoration Preference for specific uses, such as restorative dentistry, was also mentioned. In terms of the endodontist experience with the instrument, a panel member stated in endo, I would give an inferior alveolar nerve block and then automatically as a supplemental injection use the STA. We need to tell the endodontist particularly that this will work as a supplemental injection. The inferior alveolar fails so frequently in endo that we have to give a supplemental. Another panel member summed up the importance of the instrument for the endodontist by stating some dentists use PDL, and others use intraosseous, and it s actually changed our world. These are significant advances, and so what we want to do is look at the STA because I really think this could be very important in endo. Dr. Malamed asked the panel if they noticed a change in their patients stress during injection with the STA instrument. All agreed that this was the case, and one panel member related a story of a teenage patient with attention deficit disorder who d had previous treatment. The patient was apprehensive, but had no reaction upon receiving anesthesia with the STA instrument. Subsequently, when a rubber dam was being inserted, the patient became very agitated because he thought he had not been given anesthesia. Several panel members throughout the symposium shared similar experiences in which patients were unaware that they had been given anesthesia. Other panel members stated that patients appreciate that the practitioner is making the most difficult part of the procedure as comfortable as possible through the use of state-of-the-art technology. One thought leader summed it up by saying the patient becomes your partner in pain control. I have patients that will come in on their lunch hour because they can go back to work and get on the phone or go back to a meeting.they can do it even easier now thanks to an STA injection. Its much easier then an intraosseous injection. Bi-Lateral - Single Tooth Anesthesia The patient needed an extraction of the mandibular left 1st molar and a simple restorative procedure of the mandibular right 1st molar Normally I would not do a bilateral IANB due to potential post anesthesia trauma and patient comfort. An IANB was performed using an STA on the left side and an STA PDL injection on the right 1st molar. This allowed immediate treatment of the right molar while waiting for the anesthesia to take effect on the left. Martin Jablow DMD, practices general dentistry in a group setting in Woodbridge, NJ. He enjoys promoting the use of technology in the dental office to improve efficiency and patient care. As a partner in Dental Technology Solutions (www.dentaltechnologysolutions.com) he lectures and writes articles on the use of technology to enhance the practice of dentistry. Dr. Jablow can be reached by email at marty@dentaltechnologysolutions.com. The 1 st Annual International C-CLAD Symposium 2008 page 8

SPECIAL THANKS Special thanks to Dr. John Yagiela for providing valuable insights regarding how C-CLAD can be implemented as part of standard curriculum at dental schools. John Yagiela, DDS, PhD Professor and Chair Division of Diagnostic and Surgical Sciences School of Dentistry University of California, Los Angeles Los Angeles, California Special thanks to Dr. Ken Reed for providing valuable insights into how C-CLAD technology can be implemented into post-graduate programs. Kenneth Reed, DMD Private Practice, Dental Anesthesiology Tucson, Arizona Special thanks to Dr. Eugene Casagrande for his contributions and insights regarding C-CLAD and today s dental professional.

INTERESTED IN COMPUTER-CONTROLLED LOCAL ANESTHETIC DELIVERY? The 2 nd Annual C-CLAD Symposium 2009 May 1st 3rd The Ritz Carlton AMELIA ISLAND FLORIDA Contact smahnken@milestonescientific.com