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a summary of peer-reviewed research

foreword
Over the last several years, leading institutions across the globe have performed in vivo and in vitro clinical studies comparing the EndoVac to traditional endodontic irrigation techniques and other new irrigation devices. This booklet provides an overview and analysis of numerous published, peer-reviewed studies that prove the EndoVac is unparalleled in patient safety, clinical efficacy, canal cleanliness and reduction of post-operative pain. Since its introduction, EndoVac has continually received the respect and praises of expert endonontists worldwide, and has emerged as the gold standard in endodontic irrigation.

safety
In his 1974 edition of Practical Endodontics (1), Dr. Samuel Luks stated: It is highly unlikely that one can force a liquid through a constricted apical orifice, measured in microns. He was terribly wrong. Since then, numerous case histories regarding NaOCl extrusions have described an associated myriad of sequelae ranging from: a life threatening airway obstruction incident (2); to permanent facial disfigurement (3) (photo left); and even permanent neurological damage (4). The patient on the left has permanent hypoesthesia and diminished control of her facial musculature due to NaOCl apical extrusion.

efficacy
The biomass adhering to the dentinal wall (below) is endodontic biofilm. Like other biofilms, it can be an aggregate of bacteria, archaea, protozoa, fungi and algae that adheres to the dentinal wall and is capable of quorum sensing thereby effecting a defensive response when endangered. Although biofilm infections are responsible for 65% to 80% of human infections in the developed world, until now there was no direct correlation between endodontic biofilm and apical periodontitis. However, in a 2010 study, Ricucci and Siqueira (5) produced compelling evidence that apical periodontitis is a biofilm-induced dieaese. This significant finding mandates that 6% NaOCl must be used to eradicate wild endodontic biofilm, since it is the only irrigant proven totally effective against it (6).

Permanent Neurological Damage from NaOCl Extrusion.

However, this does not imply that NaOCl can or should be excluded as an endodontic irrigant; in fact its use is critical as explained at right. What this does imply is that it must be safely delivered.

Endodontic Biofilm Infection

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table of contents

Safety Studies Safety I (in vitro mechanical) J Endod 2009;35:545-549 Safety II (in vitro gel) J Endod 2010;36:338341 Safety III (clinical) J Endod 2010;36:12951301 Safety IV (computer analysis) J Endod 2010;36:875879 Efficacy Studies Apical Vapor Lock I (Histo) J Endod 2010;36:745750 Canal Cleanliness II (Histo) J Endod 2007;33:611 615 Canal Cleanliness III (Histo) J Endod 9/16/2010 E pub Canal Cleanliness IV (Histo) OOOOE 2010;109:479-484 Isthmus Cleanliness V(Histo) J Endod 2005;31:166170 Isthmus Cleanliness VI (Histo) J Endod 2010;36:13671371 Isthmus Cleanliness VII (Histo) IEJ 8/19/2010 E pub Wall Cleanliness VIII (SEM) IEJ 8/16/2010 E pub Biofilm Removal IX (Microbial) J Endod 2008;34:1374 1377 Biofilm Removal X (Microbial) J Endod 2009;35:14221427 Biofilm Removal XI (Microbial) J Endod 2010;36:509511 Microbial Control XII (Microbial) OOOOE 2010 Jan;109:e42-46 Pulpal Regeneration/Revascularization Study (Histo) OOOOE 2010;109:779-787 Ancillary Benefits Case Study by Dr. Richard Rubinstein Healing Case Study by Dr. Filippo Santarcangelo References

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Safety I: Comparative Safety of Various Intracanal Irrigation Systems


Desai J Endod 2009;35:545-549

extrusion of irrigant (%)

Comment Desai designed a study (7) to test the safety of six current irrigation devices: EndoVacs MicroCannula (MICRO), EndoVacs MacroCannula (MACRO), EndoActivator (EA), Max-i-Probe (MAX), Positive Pressure Ultrasonic (UN), and the Rinsendo (RE). It was designed to test worst case apical extrusion and was conducted using neutral atmospheric pressure (Fig A-1) and an open apex (Fig A-2). The tooth and atmospheric balancing needle were sealed to the cap of a 20 ml collection vial and then each group was tested according to manufacturers instructions (Fig-B). This test also incorporated a fluid recovery trap (Fig-C) to assay the quantity of irrigants flowing through the EndoVacs Macro and MicroCannula.

Results
100 80 60 40 20 0

MICRO

MACRO

EA

MAX

UN

RE

irrigation system used

Findings 1. The MACRO and MICRO cannulas groups did not extrude any irrigant. 2. Although EndoActivator extruded irrigant, the volume was very small, and the clinical significance is not known. However, the manufacturer s instructions at the time of research did not suggest the use of manual irrigation before using EndoActivator. In a recent publication by Ruddle, he suggested the use of intracanal irrigation before using EndoActivator. To relate these results to the manufacturer s instructions, groups 3 and 4 could be added together and then compared with the other groups. This would potentially make the differences between the EndoActivator and the EndoVac even greater. 3. The MAX, UN & RE extruded significantly more irrigant than either the MACRO or MICRO. Conclusions by Author This study concluded that the EndoVac did not extrude irrigant after deep intracanal delivery and suctioning the irrigant from the chamber to full working length.

Materials and methods

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Safety II: Comparison of Apical Extrusion of NaOCl Using the EndoVac or Needle Irrigation of Root Canals
Mitchell J Endod 2010;36:338341 Comment The Desai study (facing page 1) examined the worse case scenario of apical extrusion by using a simulated open apex open to an atmospheric neutral chamber. Clinically this would relate to a root situated in the maxillary sinus with no bone or schneiderian membrane covering. Mitchell and Baumgartner (8) chose a different method to determine apical extrusion that resembles the more common clinical situation, specifically testing irrigant (NaOCl) extrusion from a root canal sealed with a permeable agarose gel. The gel contained 1 mL 0.1% m-Cresol purple that has a pH sensitive color change from yellow at a pH of 7.4 to purple at a pH of 9. A color change to purple indicated the extrusion of NaOCl (pH = 11.4) into the gel. Unlike the Desai study the sample teeth were treated through all aspects of instrumentation to final irrigation. Findings Photos at left are representative examples from the published study appearing on page 340. The caption associated with lower left photo is: Picture 1050 Analyzed: 167875 pixels demonstrating extrusion. The Caption associated with upper left photo is: Picture 1052 Analyzed: 9649 pixels showing no extrusion. Analysis Although this study demonstrates the safety of the EndoVac system in a gel, it probably understates the danger of positive pressure, since there is no circulatory system associated within the gel. In 1963 Rickles (9) reported a fatality associated with an air embolism resulting from a root canal treatment. See page four (4) for a contemporary explanation of the Rickles study relative to NaOCl extrusion. Conclusions This study showed significantly less extrusion risk using the EndoVac system compared with needle irrigation. Note: This study considered any color change to be extrusion, even that caused by DIFFUSION through the dentinal tubules. Accurate interpretation of Apical Extrusion is depicted in the graphics. NaOCl Extrusion from positive pressure needle

No NaOCl Extrusion from EndoVac System

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Safety III: Postoperative Pain after the Application of Two Different Irrigation Devices in a Prospective Randomized Clinical Trial
Gondim J Endod 2010;36:12951301

1.8 1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2 0.0 1 2 3 Objective Pain Response via Analgesic Frequency 0.50 0.45 0.40 0.35 0.30 0.25 0.20 0.15 0.10 0.05 0.00 1 2 Subjective Pain Response via Patient Survey 3

Comment This clinical study (10) included 110 patients subdivided into two groups of 55 patients. Unlike the in vitro studies by Desai and Mitchell this study looked at the patients post-operative pain as an indication of apical extrusion. It should be recalled that in 1977 Salzgeber (11) reported that apical extrusion of an endodontic irrigant occurred on a routine basis. This was a highly controlled study in every respect from the precise method of irrigant flow rate and volume delivery to the methodology for determining post-op pain. All pulps were vital. All teeth were single rooted. All teeth were prepared with the same instrumentation technique. The only variable was positive vs. apical negative pressure. The positive pressure group used a 30 gauge Max-i-Probe up to 2 mm short of WL without binding, while the EndoVac was used at full Working Length. Post-op pain was measured subjectively by patient scoring (table top left) and objectively by measuring the frequency of a prescribed analgesic (table lower left). Findings 1. The outcome of this investigation indicates that the use of a negative apical pressure irrigation device can result in a significant reduction of postoperative pain levels in comparison to conventional needle irrigation. 2) It may be assumed that it is safe to use a negative apical pressure irrigation protocol for antimicrobial debridement up to the full working length. Analysis This clinical study is not only highly statistically significant favoring the safety of apical negative pressure but also in terms of immediate treatment outcome for the patient. This is a must read paper.

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Safety IV: Evaluation of Irrigant Flow in the Root Canal Using Different Needle Types by an Unsteady Computational Fluid Dynamics Model
Boutsioukis J Endod 2010;36:875879 Comment Although the exact etiology of the NaOCl accident is still an enigma, circumstantial evidence now strongly suggests that an intravenous injection may be the causation. The patient shown at top left (12) demonstrates a wide spread area of tissue trauma that is inconsistent with the reported in vivo characteristics reported by Pashley (13). Particular attention must be given to the right eye as this area has rich venous complex including the superior and inferior palpebral, facial and angular veins. The lower figure shows these veins circumventing the eyelid in a manner Positive consistent with the ecchymosis apparent Pressure NaOCl in the top photo. In order to experience an intravenous injection of NaOCl, a vein of appropriate size would have to be located very close to the apical termination as shown in upper right photo and a pressure exceeding 10 m of Hg would be required to exceed the venous pressure.

Vein Adjacent to Apical Foramen Findings Using a validated Computational Fluid Dynamics (CFD) model, Boutsioukis (14) determined that a non-bound, side-vented needle, extruding a clinically realistic flow of 1% NaOCl at 0.26 ml/s, placed 3 mm from Working Length produces a mean apical pressure of about 80 mm Hg! That is 800% greater than normal venous pressure, more than enough to effect an intravenous injection if an appropriate sized vein were located in the vicinity of the apical foramen. The fact pattern of a NaOCl accident described by Markose (3) also strongly suggests an intravenous injection. Analysis Safety is a function of irrigant delivery. Apical Negative pressure has proven to be a safe method of delivery to full Working Length (Desai, Miller & Gondim), while positive pressure always carries the possibility of apical extrusion (Boutsioukis). Boutsioukis concluded his finding: From a clinical point of view, the prevention of extrusion should precede the requirement for adequate irrigant replacement and wall shear stress.

Eye Lid Venous Complex

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Efficacy I: Effect of Vapor Lock on Root Canal Debridement by Using a Side-Vented Needle for Positive-Pressure Irrigant Delivery
Tay J Endod 2010;36:745750 Comment In 1971, Senia (15) reported that NaOCl failed to clean the apical 1/3 of a closed canal system. In 1974 Luks (1) wrote: Irrigating solutions are blocked by a column of air within the root canal, so that the solutions cannot reach the apical area. In 2005 this phenomena was described by Dr. Bill Costerton as an Apical Vapor Lock. In 2009, Gu (16) described the apical vapor lock using fluid dynamic references. Until April 2010 this remained a highly controversial topic because, if the theory was valid, then the dental profession would have to safely and effectively resolve the problem. Findings In 2010, Tay (17) and others, using histological methods and micro-CT scanning, verified the existence of the Apical Vapor Lock even in teeth oriented with their apex towards the center of the earth during treatment. The micro-CT scan (top), demonstrates an open root canal system that allowed the irrigant to freely escape the apex -- an error in many testing protocols. This errant test model was used in many irrigation efficacy studies including (eq. Torabinejad 4/03), and therefore their findings must be questioned (18-20). The micro-CT (bottom) clearly demonstrates that when the apex is sealed, an Apical Vapor Lock forms and resists displacement during instrumentation and final irrigation. Analysis This finding explains why the works of Baumgartner and others could not demonstrate a clean apical 1/3 in sealed root canals (21-24). The results shown on pages 6-8 could only have been realized if abundant quantities of NaOCl displaced the Apical Vapor Lock and rapidly flowed through the entire apical region. In a closed system, an Apical Vapor Lock is apparent in the apical termination (triangular arrows). White arrow indicates an open apical foramen, allowing irrigant to flow through.

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Efficacy II, III & IV: Apical Cleanliness via Histology


(1) (2) (3) Comparison of the EndoVac System to Needle Irrigation of Root Canals. J Endod. 2007;33:611-615. Comparison of the Debridement Efficacy of the EndoVac Irrigation System and Conventional Needle Root Canal Irrigation. In Vivo. J Endod 9/16/2010 E pub Comparison of the cleaning efficacy of a New Apical Negative Pressure Irrigating System with Conventional Irrigation Needles in the Root Canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010;109:479-484.

Comment Dr. Baumgartner, one of the worlds foremost experts in the field of endodontic irrigation, developed a closed system irrigation testing protocol several decades ago. Until 2007 his research staff had never achieved a presentably clean apical termination using his established protocol. Then, in 2007 (25), his department conducted the first of several EndoVac efficacy studies using matched pairs of teeth with sealed apices. Nielsen/Baumgartner Findings 2007 This study demonstrated that traditional irrigation (positive pressure) left statistically significant more gross debris on the apical walls at WL -1mm (top photo), while the EndoVac group, regardless of canal shape, proved to be extremely clean (bottom photo). Note: The large red arrow points to a small dentinal pearl indicating that the NaOCl cleaned that specific area rather than instruments. However, his findings failed to show a significant difference at the WL -3 mm level. Siu/Baumgartner Clinical Findings 2010 The Neilsen/Baumgartner study was repeated clinically (26) and the findings remained the same as the in vitro Nielsen/Baumgartner 2007 findings. Shin Findings 2009 Since the volume of irrigant differed between both groups, the study was immediately questioned. Accordingly, Shin (27) repeated the Nielsen/Baumgartner study correcting the problem: In the present study, the same amount of irrigant was used regardless of the irrigating methods. They determined that the EndoVac group did in fact produce statistically significant cleaner results at both WL -1 mm and -3 mm levels. Analysis The problem of cleaning the pulp canals terminal region (WL 0-3 mm) has always been the apical vapor lock and consideration for the patients safety. A review of the previous studies that insure a completely closed and sealed apex during testing always produces inadequate apical cleanliness when irrigated with positive pressure. This is true either with or without additional agitation techniques, provided irrigant flow and needle placement are tested in clinically realistic conditions. Traditional irrigation (red arrows) indicate debris on canal walls

EndoVac irrigation no apparent wall debris (red arrow pointing to dentinal pearl).

(1) Nielsen & Baumgartner (2) Siu & Baumgartner (3) Shin

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Efficacy V, VI & VII: Isthmus Cleaning


(1) (2) In Vivo Debridement Efficacy of Ultrasonic Irrigation Following Hand-Rotary Instrumentation in Human Mandibular Molars. J Endod 2005;31:166-170. In Vitro Comparisons of Debris Removal of the EndoActivator() System, the F File(), Ultrasonic Irrigation, and NaOCl Irrigation Alone after Hand-rotary Instrumentation in Human Mandibular Molars. J Endod 2010;36:13671371 Canal and Isthmus Debridement Efficacies of Two Irrigant Agitation Techniques in a Closed System. IEJ 8/19/10 E pub

(3)

Comment As mentioned in the foreword, Ricucci and Siqueira demonstrated that: Biofilms were significantly associated with epithelialized lesions (cysts and epithelialized granulomasor abscesses) (p < 0.001). Furthermore, they discuss the fact that biofilms located in isthmus areas are definitely more difficult to reach and showed the photo at the top as an example. Although it is impossible to reach and clean the isthmus area with instruments, it is not impossible to reach and totally clean these areas with NaOCl when the method of irrigation is safe and efficacious. In an effort to determine the most efficacious method for removing organic material from the isthmus area of lower molars, regardless of safety considerations, several different studies have addressed this important issue. See table lower right (28 30). Findings The ONLY current method of endodontic irrigation capable of cleaning 100% of the isthmus area is the EndoVac. Note #1 The bottom photo was of a lower molar and only one canal was instrumented, yet the associated canal and isthmus are 100% free of organic debris. Note #2 It was not necessary to over-instrument the critical apical area to achieve a clean isthmus and associated canal. Final Irrigation EndoActivator Passive Ultrasonic F File Manual Dynamic Max-i-Probe Pressure Ultrasonic EndoVac (1) Gutarts (2) Klyn (3) Susin, Tay & Pashley

Biofilm Infected Isthmus (5)

EndoVac Cleaned Isthmus @ WL 1mm Isthmus Cleaning % Clean @ WL 1mm 76% (2) 81% (2) 81% (2) 84% (3) 92% (2) 97% (1) 100% (3)

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Efficacy VIII: Root Canal Debridement Using Manual Dynamic Agitation or the EndoVac for Final Irrigation in a Closed System and an Open System
Parente/Tay/Pashley IEJ 8/16/2010 E pub

Comment Contrary to popular belief, dentinal tubules do not extend in abundance all the way to the apical termination of the root canal. Fig-1 (very top), demonstrates absence of tubules in the canal wall near the apical foramen. Fig-2 (very bottom) demonstrates abundant well organized tubules as a normal morphological feature 4 millimeters from the apical termination. SEM Interpretation Accordingly, the lack of tubules in the most apical segment of the root canal made it impossible to apply the Torabinejad scoring method of using dentinal tubules as a scoring grid. Fig-1 (very top) demonstrates a wall devoid of any tubules, except one indicated by the hand pointer. The cracking appearance apparent in the Manual Dynamic group is a result of smear layer desiccation. The apparent small particles are classified as debris. Therefore, debris count and wall appearance, not tubules, were used to score the cleanliness. Findings The Parente/Tay (31) group assumed the null hypothesis that regardless of method of irrigant delivery (positive pressure with manual dynamic agitation or apical negative pressure) both would produce the same results. Conclusion: The null hypothesis was rejected; the presence of a sealed apical foramen adversely affected debridement efficacy when using manual dynamic agitation but not the EndoVac. Apical negative pressure irrigation is an effective method to overcome the fluid dynamics challenges inherent in closed canal systems. Analysis When any study shows a photo rich with dentinal tubules and describe it as the apical 1/3 they are in fact demonstrating the very top of the apical 1/3, not the critical apical termination most commonly devoid of any tubules (32).

Fig-1 Canal wall anatomy at 1 and 4 mm from apical termination

Fig-2 Smear layer and debris removal at 1 mm from WL

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Efficacy IX: Antimicrobial Efficacy of Two Irrigation Techniques in Tapered and Nontapered Canal Preparations: An In Vitro Study
Hockett J Endod 2008;34:1374-1377 Comment Since it has been determined that apical periodontitis is a biofilm-induced disease, it is now important to focus on methods to eradicate its presence within the root canal system. In 2008 the first paper testing the ability of the EndoVac to remove biofilm to full working length was published by Hockett (33). After shaping the apical area to a F3 ProTaper and #35/.02 hand instrument, his research team used E. faecalis to grow a thick biofilm for thirty days. SEM bottom demonstrates verification of biofilm. Findings The modified contamination protocol used for this investigation achieved well established bacterial biofilms attached to the dentinal wall as exhibited by the high CFU counts in all samples (except negative controls) and confirmed with SEM in two positive control samples. All the specimens irrigated with the apical negative-pressure irrigation technique rendered negative cultures obtained after 48 hours. Eight specimens of the positive-pressure irrigation groups rendered a positive culture at the end of the incubation period. A statistically significant difference was evident when comparing the apical negative pressure irrigation to the traditional positive-pressure irrigation for negative culture (24/24 versus 16/24 with a two-sided p value of 0.004). Analysis Although not discussed in the study, the top SEM demonstrates dentinal tubules from the EndoVac-treated group just above the 2 mm level. They are devoid of any bacteria! Not only was the biofilm eradicated from the walls of the root canal system, but individual bacteria were cleared from the tubules. The next two studies discussed on page 10 did find traces of bacteria, but their methods differed from Hockett, as will be explained. These bacteria were found in the tubules and their significance alone to overall success is questionable if the entire root canal system is otherwise properly cleaned, disinfected and obturated (34).

EndoVac Irrigation demonstrate absence of bacteria in tubules

Verification of Dense Biofilm within Root Canal System

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Efficacy X & XI: Microbial Control


(1) (2) Brito PR, Souza LC, de Oliveira JCM, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the Effectiveness of Three Irrigation Techniques in Reducing Intracanal Enterococcus Faecalis Populations: An in Vitro Study. J Endod 2009;35:1422-1427. Miller TA, Baumgartner JC. Comparison of the Antimicrobial Efficacy of Irrigation Using the EndoVac to Endodontic Needle Delivery. J Endod 2010;36:509-511.

Comment Since Hockett, two other biofilm papers have tested the EndoVac against positive pressure systems. Specifically Brito (35) and Miller (36). Their methods were basically the same as Hocketts in terms of using a sealed canal system and cultivating the biofilm, the difference was in the sampling technique. Brito used a far more aggressive sampling technique than Hockett by enlarging the canal walls with three sizes larger than the last file to the apex, while Miller crushed the tooth and then sampled. Findings Both studies indicated that the EndoVac mathematically out performed the other test groups (Tables 1 & 2). In the Brito study they achieved 9/20 negative cultures with the EndoVac, still more than with positive pressure.

Analysis 1. In both studies the researchers had to reach deep into the dentinal tubules (top SEM page 9) to detect viable bacteria. In other words, the intracanal biofilm was eradicated from the root canal system. A complex biofilm as shown on the introductory page could not form in a dentinal tubule. Furthermore, once the biofilm is eradicated, a filling material (sealer or gutta-percha) can obturate its space thus preventing future reformation. 2. Since both of these studies make it appear that either positive or apical negative can produce the same results, one must ask: What is the difference? SAFETY is the difference cited in both articles. Both Brito and Miller cited the Desai safety study; however, neither cited the more convincing Mitchell and/ or Gondim studies because they were not yet available prior to their submission. Recalling the conclusions of the Boutsioukis study: From a clinical point of view, the prevention of extrusion should precede the requirement for adequate irrigant replacement and wall shear stress.
14000 12000 10000 8000 6000 4000 2000 0 Traditional EndoVac Control

7E+04 6E+04 5E+04 4E+04 3E+04 2E+04 1E+04 0E+01 Conventional EndoActivator EndoVac Control

Table-1 Brito Findings

Table-2 Miller Findings

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Efficacy XII: Apical Negative Pressure Irrigation Versus Conventional Irrigation Plus Triantibiotic Intracanal Dressing on Root Canal Disinfection in Dog Teeth
Cohenca OOOOE 2010 Jan;109:e42-46 Comment Intracanal antibiotics ranging from arsenic to the more recent triple antibiotic compound (Trimix = Cipro, Minocin, Flagyl) have been used for decades as a means of canal disinfection (37). Recent pulpal regeneration/revascularization studies have paid particular attention to the apparent benefits of Trimix (38). Until a research team from the USA, Mexico, Brazil and Paraguay tested NaOCl against Trimix in vivo (39), the literature was silent in this area. This study devitalized the pulps and induced periapical lesions in puppies (top photo). The pulp canals were then treated in two different groups: (1) 2.5% NaOCl* delivered via EndoVac system and (2) Trimix. Two separate studies were derived from the same experiment - microbiological efficacy and pulpal regeneration/revascularization - see page 12. Microbiological Findings In summary, the present results demonstrated that reliable disinfection can be achievable with efficient and safer irrigation delivery systems, such as the EndoVac system, and that the use of intracanal antibiotics might not be necessary. Analysis This EndoVac method of pulp canal disinfection is clearly advantageous to the Trimix method because: 1) It doesnt discolor the tooth (bottom photo); 2) the protocol using the triantibiotic intracanal dressing has potential biologic and clinical complications, including the development of resistant bacterial strains (40) and 3) allergic reaction to the intracanal dressing (41) as the most concerning side effects. *NOTE: This in vivo study used 2.5% NaOCl because it was conducted in Brazil where the use of a higher concentration is prohibited for root canal irrigation. A study by Hand (42) demonstrated the greatly reduced potential (244%) between using 2.5% vs. 5.25% for NaOCl to hydrolyze tissue. Had this study used 6% NaOCl, although the safety would not have been an issue, the microbial outcome may have significantly favored the EndoVac system. In Vivo Study

Trimix Discoloration

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Revascularization and Periapical Repair After Endodontic Treatment Using Apical Negative Pressure Irrigation Versus Conventional Irrigation Plus Triantibiotic Intracanal Dressing in Dogs Teeth with Apical Periodontitis
da Silva OOOOE 2010;109:779-787 Comment This is part II (43) of the in vivo study discussed on page 11. Findings Although significant difference was found only for the periapical inflammatory infiltrate, irrigation with apical negative pressure irrigation provided more exuberant mineralized tissue formation, more structured apical and periapical connective tissue, and a more advanced repair process when compared with the group where apical positive pressure irrigation plus triantibiotic intracanal dressing was used. In this way, a comparative analysis of the 2 techniques allows concluding that irrigation/aspiration with the apical negative pressure irrigation promoted favorable conditions for the occurrence of periapical repair, owing to adequate cleaning and disinfection of the root canal, or to the lack of periapical tissue irritation, and the use of intracanal antibiotics might not be necessary. Analysis The histological section (left) represents: Closure of the apical opening by mineralized tissue deposition (T), normal periodontal ligament (PL), and alveolar bone (B). The Trimix group demonstrated less exuberant vessels and nerve bundles than those observed in the EndoVac group and there was more intense inflammatory infiltrate observed in the Trimix group. Concluding Comment This study not only portends routine success in the area of pulpal regeneration/revascularization, but also in the area of improved routine RCT (see page 14), and the probability that single-visit RCT may produce enhanced success since the root canal system is at its maximum microbial control with biofilm eradication the moment that final irrigation is complete.

Apex of EndoVac Treated Group (see Analysis for complete description)

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Ancillary Benefits
Case by Dr. Richard Rubinstein, Endodontist, Farmington Hills, MI

Separated Instrument Removal Dr. Richard Rubinstein writes: The following case illustrates a serendipitous use of the MacroCannula. The patient was a 48-year-old female who had just finished chemotherapy for breast cancer. Radiographic examination (top A) revealed a previous root canal attempt performed over 10 years ago with periapical radiolucencies on both the mesial and distal roots. In addition, a separated instrument was identified in the distal root canal system. Apical patency and working lengths were established in the distal lingual canal. After careful instrumentation of the distal buccal canal, the separated instrument was bypassed and loosened. The MacroCannula was inserted into each canal and irrigation with 6% NaOCl continued for 30 seconds as suggested by the manufacturer. Upon removal of the MacroCannula from the distal buccal canal, the separated instrument could be seen captured in the opening of the MacroCannula, a serendipitous happening indeed (top inserted photo).

Clogging Comment A criticism occasionally directed at the EndoVac system is the problem of clogging the MicroCannula (above, top). Notice the mass of debris that was being evacuated from the pulp canal system via the MacroCannula (above, bottom) at the moment it sucked in the separated instrument (white arrows). The MacroCannula must be used in each canal for 30 seconds before the Micro is placed at Working Length. Otherwise, the canal may not be appropriately clear of debris and the holes of the MicroCannula may become clogged. The picture to the left is proof of the quantity of material removed by both the Macro and MicroCannula during their use. Normally at this point in root canal preparation, the clinician would be drying the canal and leaving that debris in cul de sacs, fins, and isthmus areas. Final note There is a learning curve for using the EndoVac system of approximately five cases. Careful understanding of the manufacturers directions is critical.

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Healing
Case by Dr. Filippo Santarcangelo, Practice Limited to Endodontics, Bari, Italy

Case History An asymptomatic eleven (11) year old male presented for a routine dental examination. The pre-operative X-ray revealed a large lesion that seemed to involve both roots of the lower right first molar and also extended to the mesial root of the second molar. Due to the extensive nature of the lesion, the recommended treatment plan was to remove both the first, and second molars, followed by extensive curettage. The patients mother was also advised of the possibility of permanent paraesthesia to the inferior alveolar nerve. The mother sought a second opinion. After confirming the lower first molar was non-vital and the second molar was vital, the mother accepted the alternative choice of routine root canal treatment with use of the EndoVac on the first molar. The treatment was completed in a single visit and the patient reported no postoperative pain or other complications. The patient was recalled judiciously every six (6) months to access healing. The forty-eight (48) month recall demonstrated not only dense bone fill, but closure of the distal root apex.

Case by Dr. Filippo Santarcangelo

Pre-operative X-ray
Case by Dr. Filippo Santarcangelo

Forty-eight (48) Month The massive pre-op lesion in direct contact with the obvious open apices of the 11-year-old child presented a serious irrigation safety issue. The EndoVacs proven safety advantage allowed the clinician to safely deliver an abundance of 6% NaOCl to full working length, thus helping ensure phenomenal osseous remolding and spectacular healing in a single visit.

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References

1. Luks, Samuel. Practical Endodontics. Philadelphia * Toronto: J.B. Lippincott Co., 1974 pg. 82 2. Bowden J, Ethunandan M, Brennan P. Life-threatening airway obstruction secondary to hypochlorite extrusio during root canal treatment Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2006;101:402-4 3. Markose G, Cotter CJ, Hislop WS. Facial atrophy following accidental subcutaneous extrusion of sodium hypochlorite. Br Dent J. 2009 Mar 14;206(5):263-4. 4. Pelka M, Petschelt A. Permanent mimic musculature and nerve damage caused by sodium hypochlorite: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Sep;106(3):e80-3. 5. Ricucci D, Siqueira JF Jr. Biofilms and Apical Periodontitis: Study of Prevalence and Association with Clinical and Histopathologic Findings J Endo. 2010 Aug;36(8):1277-88 6. Clegg MS, Vertucci FJ, Walker C, Belanger M, Britto LR. The effect of exposure to irrigant solutions on apical dentin biofilms in vitro. J Endod. 2006 May;32(5):434-7. 7. Desai P, Himel V. Comparative Safety of Various Intracanal Irrigation Systems. J Endod 2009;35(4):545-49. 8. Mitchell RP, Yang SE, Baumgartner JC. Comparison of apical extrusion of NaOCl using the EndoVac or needle irrigation of root canals. J Endod 2010;36(2):338-41. 9. Rickles Nh, Joshi Ba. A Possible Case In A Human And An Investigation In Dogs Of Death From Air Embolism During Root Canal Therapy. J Am Dent Assoc. 1963 Sep;67:397-404. 10. Gondim E Jr., Setzer F, dos Carmo CD, Kim S. Postoperative Pain after the Application of Two Different Irrigation Devices in a Prospective Randomized Clinical Trial Irrigation Devices in a Prospective Randomized Clinical Trial. J Endod. 2010 Aug;36;(8):1295-1301 11. Salzgeber M, Brilliant LD. An in vivo evaluation of the penetration of an irrigating solution in root canals. J Endod. 1974;3(10):394-8

12. Hulsmann M, Rodig T, Nordmeyer S. Complications during root canal. Endo Topics 2009;16,:2763 13. Pashley EL, Birdsong NL, Bowman K, Pashley DH. Cytotoxic effects of NaOCl on vital tissue. J Endod. 1985 Dec;11(12):525-8. 14. Boutsioukis C, Verhaagen B, Versluis M, Kastrinakis E, Wesselink PR, van der Sluis PR. Evaluation of Irrigant Flow in the Root Canal Using Different Needle Types by an Unsteady Computational Fluid Dynamics Model. J Endo. 2010;36(5):875-97 15. Senia ES, Marshall FJ, Rosen S. The solvent action of sodium hypochlorite on pulp tissue of extracted teeth. Oral Surg Oral Med Oral Pathol. 1971 Jan;31(1):96-103. 16. Gu LS, Kim JR, Ling J, Choi KK, Pashley DH, Tay FR. Review of contemporary irrigant agitation techniques and devices. J Endod. 2009 Jun;35(6):791-804. 17. Tay FR, Gu LS, Schoeffel GJ, Wimmer C, Susin L, Zhang K, Arun SN, Kim J, Looney SW, Pashley DH. Effect of vapor lock on root canal debridement by using a side-vented needle for positive-pressure irrigant delivery. J Endod. 2010 Apr;36(4):745-50. 18. Torabinejad M, Cho Y, Khademi AA, Bakland LK, Shabahang S. The effect of various concentrations of sodium hypochlorite on the ability of MTAD to remove the smear layer. J Endod. 2003 Apr;29(4):233-9 19. Tinaz AC, Alacam T, Uzun O, Maden M, Kayaoglu G. The effect of disruption of apical constriction on periapical extrusion. J Endod. 2005 Jul;31(7):533-5. 20. van der Sluis LW, Gambarini G, Wu MK, Wesselink PR. The influence of volume, type of irrigant and flushing method on removing artificially placed dentine debris from the apical root canal during passive ultrasonic irrigation. Int Endod J. 2006 Jun;39(6):472-6. 21. Fukumoto Y, Kikuchi I, Yoshioka T, Kobayashi C, Suda H. An ex vivo evaluation of a new root canal irrigation technique with intracanal aspiration. Int Endod J. 2006 Feb;39(2):93-9. 22. Usman N, Baumgartner JC, Marshall JG. Influence of instrument size on root canal debridement. J Endod. 2004 Feb;30(2):110-2.

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23. Albrecht LJ, Baumgartner JC, Marshall JG. Evaluation of apical debris removal using various sizes and tapers of ProFile GT files. J Endod. 2004 Jun;30(6):425-8. 24. Berutti E, Marini R. A scanning electron microscopic evaluation of the debridement capability of sodium hypochlorite at different temperatures. J Endod. 1996 Sep;22(9):467-70. 25. Nielsen BA, Baumgartner CJ. Comparison of the EndoVac system to needle irrigation of root canals. J Endod. 2007;33(5):611-5. 26. Siu C, Baumgartner JC. Comparison of the Debridement Efficacy of the EndoVac Irrigation System and Conventional Needle Root Canal Irrigation. In Vivo. 2010 (In Press 9/2010) 27. Shin SJ, Kim HK, Jung IY, Lee CY, Lee SJ, Kim E Comparison of the cleaning efficacy of a new apical negative pressure irrigating system with conventional irrigation needles in the root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):479-84. 28. Gutarts R, Nusstein J, Reader A, Beck M. In Vivo Debridement Efficacy of Ultrasonic Irrigation Following Hand-Rotary Instrumentation in Human Mandibular Molars. J Endod. 2005 March;31(3):166-70. 29. Klyn SL, Kirkpatrick TC, Rutledge RE. In Vitro Comparisons of Debris Removal of the EndoActivator(TM) System, the F File(TM), Ultrasonic Irrigation, and NaOCl Irrigation Alone after Hand-rotary Instrumentation in Human Mandibular Molars. J Endod. 2010 Aug;36(8):1367-71. 30. Susin L, Parente JM, Loushine RJ, Ricucci D, Bryan T, Weller RN, Pashley DH, Tay FR. Canal and isthmus debridement efficacies of two irrigant agitation techniques in a closed system. IEJ (E pub 8/19/2010) 31. Parente JM, Loushine RJ, Susin L, Gu L, LooneySW, Weller RN, Pashley DH, Tay FR. Root canal debridement using manual dynamic agitation or the EndoVac for final irrigation in a closed system and an open system. IEJ (8/16/2010 E pub) 32. Mjr IA, Smith MR, Ferrari M, Mannocci F. The structure of dentine in the apical region of human teeth. Int Endod J. 2001 Jul;34(5):346-53. 33. Hockett JL, Dommisch JK, Johnson JD, Cohenca N. Antimicrobial efficacy of two irrigation techniques in tapered and nontapered canal preparations: an in vitro study. J Endod. 2008 Nov;34(11):1374-7.

34. Peters LB, Wesselink PR, Moorer WR. The fate and the role of bacteria left in root dentinal tubules. Int Endod J. 1995 Mar;28(2):95-9. 35. Brito PR, Souza LC, de Oliveira JCM, Alves FR, De-Deus G, Lopes HP, Siqueira JF Jr. Comparison of the effectiveness of three irrigation techniques in reducing intracanal Enterococcus faecalis populations: an in vitro study. J Endod 2009;35(10):1422-7. 36. Miller TA, Baumgartner JC. Comparison of the antimicrobial efficacy of irrigation using the EndoVac to endodontic needle delivery. J Endod. 2010 Mar;36(3):509-11. 37. Mohammadi Z. Antibiotics as intracanal medicaments: a review. J Calif Dent Assoc. 2009 Feb;37(2):98-108. 38. Windley W 3rd, Teixeira F, Levin L, Sigurdsson A, Trope M. Disinfection of immature teeth with a triple antibiotic paste. J Endod 2005;31:439-43. 39. Cohenca N, Heilborn C, Johnson JD, Flores DS, Ito IY, da Silva LA. Apical negative pressure irrigation versus conventional irrigation plus triantibiotic intracanal dressing on root canal disinfection in dog teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Jan;109(1):e42-6. 40. Eickholz P, Kim TS, Brklin T, Schacher B, Renggli HH, Schaecken MT, et al. Nonsurgical periodontal therapy with adjunctive topical doxycycline: a double-blind randomized controlled multicenter study. J Clin Periodontol 2002;29:108-17. 41. de Paz S, Perez A, Gomez M, Trampal A, Dominguez Lazaro A. Severe hypersensitivity reaction to minocycline. J Invest Allergol Clin Immunol 1999;9:403-4. 42. Hand RE, Smith ML, Harrison JW. Analysis of the effect of dilution on the necrotic tissue dissolution property of sodium hypochlorite. J Endod. 1978 Feb;4(2):60-4. 43. da Silva LA, Nelson-Filho P, da Silva RA, Flores DS, Heilborn C, Johnson JD, Cohenca N. Revascularization and periapical repair after endodontic treatment using apical negative pressure irrigation versus conventional irrigation plus triantibiotic intracanal dressing in dogs teeth with apical periodontitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 May;109(5):779-87.

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I have been using the EndoVac for the last two years in every single case that I have treated. The clinical impression that I have in my experience is superior cleaning of the root canal system, a larger amount of anatomy obturated and a reduction of post-operative pain for my patients. In retreatment using the microscope, the root canal can be dried more quickly, avoiding the need to use paper points, and making the procedure easier and faster. I strongly recommend the use of this simple and effective method of irrigating the root canal system to every practitioner who performs Endodontics.
Arnaldo Castellucci MD, DDS Florence, Italy

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