We have been asked by many dentists regarding our thoughts on a new irrigating technology called GentleWave by Sonendo Inc. After meeting with the GentleWave representatives, an in-office demonstration, performing the procedure on extracted teeth, discussing with colleagues using the product and critically reviewing the clinical research on this technology, we are prepared to answer the question so many of you have asked, "What's the deal with GentleWave?"
|"Thrill of the Fill" accomplished using the EndoActivator|
At SSE, we have been early adopters of many new, and lasting technologies in endodontics such as microscopes and CBCT. Our process in adapting a new technology, like GentleWave, is to carefully evaluate the technology, including the claims made by the manufacturers and a critical evaluation of whether the published evidence supports those claims.
It is also important to evaluate the financial side of any large investment to make sure that it is a fiscally sound decision that makes sense for our patients and our practice. Failure to do so leaves a practice in a position where a financial commitment to a technology then determines how the technology is applied to the patient's care.
In the #1 bestselling book, Good to Great by Jim Collins, he makes a point about our "cultural obsession with technology and technological-driven change". Nowhere can you find a group of professionals more obsessed with technology than in dentistry!
However, in Collins extensive study of what made good companies become lasting, great companies, he noted that the great companies "maintained a balanced perspective on technology, while most companies become reactionary, lurching and running about like Chicken Little..." Collins finds that technology alone is never a primary cause of either greatness or decline.
If you are following the information that the GentleWave manufacturer is delivering to offices throughout the greater Phoenix area it is obvious they are making a sizable marketing investment. With a clever marketing approach, they have included in the purchase price of the system, a marketing budget to promote the system and the practice who has invested in it. You have likely received several invitations to CE events promoting the technology. There are several phrases being used by the sales-force to excite dentists about GentleWave such as "the thrill of the fill", "this is the new standard of care", "anatomy like never before seen" and "becoming part of the club". There appears be an effort by the manufacturers and early adopters to create an impression that the evidence is in and this technique is proven to be superior to conventional irrigation methods. If you are not adopting the technology now, you will be left behind...
A short summary of our decision regarding the GentleWave procedure as to why we have decided not invest in the technology yet because it will cost patients more, increase treatment time, and decrease our productivity without clinical evidence of improved outcomes was posted on the blog several months ago. We will continue to watch the technology, its improvement and evaluate the evidence published over time.
The following sections provide more detail into our evaluation regarding the claims made by GentleWave.
What Does the Research Say About GentleWave?
The initial clinical study which made claims of 97% success rates, improved cleaning of canals, isthmuses & lateral canals & improved cleaning had some major design flaws and biases. Design bias, attrition bias, selection & sampling bias and sponsorship bias were all evident in this study, including a failure to include proper positive and negative controls.
The second clinical study improved upon many of major design flaws & biases of the first study, yet again failed to include positive and negative controls.
Failure to include controls in the clinical studies is concerning to us. This failure in study design, is hard to comprehend, unless a direct comparison with conventional techniques was not desired or conventional techniques were equally effective. We have also asked why there has not yet been a double blind, randomized, controlled study performed?
Why have the universities and residency programs not published about the Gentlewave technique? After discussing this with several people involved at that level, the reason appears to be that if a university accepts any financial support from the company, including providing the unit, the company insists on controlling the publication of any research results.
So while we can understand the company's desire to protect its significant investment in the development of it's technology, their scientific research appears designed as a marketing tool to support manufacturer claims.
A properly designed study, (randomized, double blinded study with proper controls) will go a long way to overcome sponsorship bias that up to now has been evident in the research.
In fact we have not been able to find one study where the authors are not directly tied to and supported by Sonendo. We will continue to watch
for this evidence and keep you updated.
3 Dimensional Cleaning, Shaping & Filling
One of the biggest claims made regarding the GentleWave technique is "improved removal of organic matter" and creating a "higher standard of clean". Evidence provided for this claim are usually images of more complex anatomy picked up when the tooth is obturated. The advocates call this "the thrill of the fill".
However, the idea of cleaning and filling lateral canals and isthmuses is not unique to GentleWave. In our practice we have used both ultrasonic and sonic activation of irrigating solutions which has provided 3D cleaning and shaping of complex canal anatomy.
I have included several radiographic that demonstrate the "Thrill of the Fill" routinely seen at SSE using sonic activation of irrigating solutions. After our hands on demonstration with the GentleWave, I began putting aside radiographs after using sonic activation and found that the fill results were equally impressive.
In the end, we need to be honest with ourselves. How many teeth are really returning to our office as failures because we didn't clean the tooth well enough?
From our experience - very few.
When patients return to our office with a non-healing root canal procedure, typically it is because the tooth is fractured, not because it wasn't clean. We would love to add the Gentlewave technology to our office but first we need to see a tangible benefit to our patients. That day may come, but for now we would like to see more evidence than "because the company says it's better", before we invest in this technology.
In Jim Collins' bestselling book, Good to Great, he discussed the importance of getting the right people on your team. He describes your team as a bus and if you get the right people on your bus, it doesn't matter where you take your bus, you will be successful. The follow concepts are a summary of Collins's concepts of finding the right poeple from Chapter 3, p. 41-63.
In “Great” businesses, people are not your most important asset. The right people are. Great businesses make a priority on finding the right people.
CONCEPT: If you have the right people on the bus, the problem of how to motivate and manage people largely goes away. With the right people, you can take the bus anywhere it needs to go.
CONCEPT: If you have the right people on the bus, they will do everything within their power to build a great company, not because of what they will “get” for it, but because they cannot imagine settling for anything less. The purpose of a compensation system is not to get the right behaviors from the wrong people, but to get the right people on the bus and keep them there.
CONCEPT: In finding the “right” people, greater weight is placed on character attributes than on specific educational background, practical skills, specialized knowledge or work experience.
CONCEPT: Great companies have rigorous – not ruthless – cultures. A rigorous culture means consistently applying exacting standards at all times and at all levels – especially in upper management. The only way to deliver to the people who are achieving is to not burden them with the people who are not achieving.
· To let people languish in uncertainty for months/years, stealing precious time in their lives that they could use to move on to something else, when knowing that they are not going to make it – that is ruthless
· To deal with it right up front and let people get on with their lives – that is rigorous
CONCEPT: Practical disciplines for being rigorous – not ruthless
1. When in doubt, don’t hire – keep looking. The ultimate throttle on growth is not markets, technology, competition or products. It is the ability to get and keep enough of the right people.
2. When you know you need to make a people change, ACT. The right people don’t need to be managed. Guided – Yes, Taught – Yes, Lead – Yes, - but not tightly managed.
a. Great leaders don’t rush to judgment. They invest substantial effort in making sure they have someone in the right seat before concluding they have the wrong person on the bus. Instead of firing honest and able people who are not performing well, it is important to try to move them once or even two or three times to other positions where they might blossom.
3. Put your best people on your biggest opportunities, not your biggest problems. Managing problems can only make you good whereas building your opportunities is the only way to become great.
CONCEPT: Right People + Great Company = Great Life. Balance in work and life is possible when you have the right people on the bus. Finding the right people is key in finding that balance and having a great life. If we are not spending the vast majority of our time with people that we love and respect – how will we ever have a great life? Great life is made up of people who love what they do and love who they do it with.
There are differing opinions regarding single-visit vs. multiple-visit endodontics. Some clinicians feel strongly that teeth with apical periodontitis (necrotic or retreatment) need the extra step of CaOH therapy to be successful while others are comfortable with these cases being done in a single visit. What does the research say regarding this? Here's a summary of the more recent research:
Please note that the systematic reviews, in an effort to summarize the existing research and find the best evidence, exclude review papers, case studies, review studies and studies that are determined to be "low evidence" and focus on randomized clinical trials or quasi-randomized clinical trials. However, like most of our dental research, there is a serious lack of studies that can be considered "high-level" evidence, large enough sample size, good research design and proper identification of study bias. This is a problem found throughout our scientific research and requires the reader to evaluate the quality of research on a study by study basis.
Single versus Multiple Visits for Endodontic Treatment of Permanent Teeth (A Cochrane Review)
by Manfredi et. al. 2016, included in their review, 25 randomized controlled trials, of which only 3 studies were found to be a low risk of bias, 8 unclear bias levels and 14 high bias levels. They found no evidence of a difference between single visit or multiple visit treatment in terms of radiological failure, immediate post operative pain, swelling or flare-up incidence, sinus tract formation or complications
. There was moderate evidence that patients undergoing single step treatment were more likely to use painkillers over those undergoing multiple visit treatment.
A Systematic Review of Nonsurgical Single-Visit Versus Multiple-Visit Endodontic Treatment
by Wong et. al 2014 which reviewed a total of 47 papers of clinical trials on the subject. Meta-analysis showed that post-operative complications of both groups were similar. Neither group could guarantee the absence of post-operative pain. Neither single-visit or multiple-visit treatment had superior results in terms of healing or success rates.
Single-Visit or Multiple-Visit Root Canal Treatment: Systematic Review, Meta-Analysis and Trial Sequential Analysis
by Schwendicke et. al. 2017 included 29 trials (4341 patients), of which all but 6 showed high risk of bias. Based on 10 trials, risks of complications was not significant. Based on 20 studies, risk of pain was not significant. Based on 8 studies, risk of flare-up was higher in single-visit treatment. Conclusion was insignificant evidence to rule out whether important differences between these strategies exist.
Outcome of Single- vs. Multiple-Visit Endodontic Therapy of Non-Vital Teeth: A Meta-Analysis
by Almeida et. al. 2017 is a review of 17 randomized clinical trials of non-vital teeth. They found no difference between single or multiple visit treatment in regard to peri-apical repair or microbiological control. They did find that single-visit treatment results in 21% less post-operative pain.
Single-Visit More Effective Than Multiple-Visit Root Canal Treatment?
by Hargreaves 2006 is a review that includes 3 randomized controlled trials including 146 cases. In this review, included NSRCT of teeth with necrosis or signs of periapical bone loss - excluding pretreatment and surgical tx. It was concluded that single-visit root canal treatment was slightly more effective than multiple-visit treatment with a 6.3% higher healing rate.
However this difference was not statistically significant (P = 0.3809).
Single Versus Multi-visit Endodontic Treatment of Teeth with Apical Periodontitis: An In Vivo Study with 1-Year Evaluation
by Gill et. al 2016, found no significant differences in healing between teeth treated in single visit, multi-visit without dressing and multi-visit with CaOH dressing.
Treatment Outcomes of Single-Visit Versus Multiple-Visit Non-Surgical Endodontic Therapy: A Randomized Clinical Trial
by Wong et. al. 2015, was a university study performed by general dentists, on 220 patients followed for at least 18 months. They reported no significant difference in success rate or prevalence of post-operative pain between the single visit or multiple visit treatments.
In my opinion, the evidence does not support that multi-step initial endodontic treatment, even of necrotic teeth, has any significant improvement in outcomes over single step treatment. In my experience, patients usually prefer to have their endodontic treatment in single-step treatment as well.
BIAS ALERT: In an effort to identify my own biases, I would share that I perform the majority of my endodontic procedures in a single-step. I do use CaOH occasionally on retreatment cases that are not healing as expected or when I run out of time to complete treatment in a single step.