Perio Protect®
Perio Protect® is a custom-fit tray made by a specialized dental laboratory from impressions of the patient’s mouth taken by a dentist. The company states that, “Perio Protect® is a comprehensive method that is customized for individual patients to help manage biofilms, communities of bacteria, growing in the spaces or pockets between teeth and gum tissue. The overall goal of the Perio Protect Method™ is to manage oral biofilm with minimally invasive dentistry for lasting oral health.”
What is the Perio Protect Method™
Perio Protect Method™ is a system for treating periodontal disease that is based on tray delivery of medicaments. It is marketed by Perio Protect LLC. The company certifies dental practices in the Perio Protect Method™. Dental practices that want to be so certified receive from the company: training on application of the method, including information on prescription for tray manufacturing; recommended medicament to be used with tray; treatment schedule; and protocol. The company also provides patient education materials, marketing support, and information on insurance filing. At present, there is no specific insurance code for perio-tray delivery of medications.
According to Perio Protect LLC, who benefits from the Perio Protect Method™ and How
According to Perio Protect LLC, certified Perio Protect dentists can expect multiple benefits for their patients, hygienists, and their practices. As quoted from the company’s marketing materials, these include:
- Patients – cleaner teeth so extremely compliant
- Hygienists – complex cleaning becomes simple cleaning, saving time
- Dentist – no new equipment or staff needed, delegate 90% of treatment system to office staff, saving time and money
- The practice – creates new source of recurring revenue and a way of treating perio patients
According to Perio Protect LLC’s marketing materials, what are the benefits of the Perio Protect Method™
According to Perio Protect LLC, as quoted from its website: The Perio Protect Method uses an FDA-cleared medical device that directs antimicrobial agents of the doctor’s choice into the gingival sulcus and helps maintain it at the source of the periodontal infections. These medications:
- may be delivered to the source of the infection
- aid in reducing the bacteria
- help to decrease the host inflammation when reducing the bacteria
- help promote healing
- decrease the bacteria which may help improve oral malodor
- have been reported in professional journals to modify the plaque and biofilm
- are bleaching agents and may whiten the teeth
- may provide long-lasting results and reduce the need for surgery
Is it FDA approved
The Perio Protect® product was never approved by FDA through the pre-market approval process. Rather, pursuant to 21 U.S.C. sec. 510(k), it was cleared by FDA on January 23, 2004, for distribution in the United States on grounds that it is “substantially equivalent” to a product distributed by Hoyt Laboratories and classified as a “disposable fluoride tray” under 21 C.F.R. § 872.6870.
What is the intended use described in the FDA clearance?
As quoted from Perio Protect LLC’s marketing materials:
- [T]o place solutions of the clinician’s choice into gingival crevices or periodontal pockets…deeper…than is possible with traditional fluoride trays.
- The choice of solution, the frequency of use, and the time the tray is to be in place are a part of the practice of dentistry, and are to be determined by the clinician.
What research studies have been published on this product
The Academy is unaware of any randomized, controlled clinical trials evaluating the efficacy of the therapy that have been published in a peer-reviewed scientific journal with a generally accepted scholarly reputation. Perio Protect LLC cites three abstracts published on the Perio Protect® Method:
- Initial Study of the Perio Protect™ Treatment for Periodontal Disease, L.E. Wentz, A.M. Blake, D.C. Keller, and B.J. Sindelar, J Dent Res 85(A): 1164, 2006.
- SEM Results of Periopathogenic Control with the Perio Protect Method, D.C. Keller, B. Costerton, C. Schaudinn, and G.S. Keller, J Dent Res 86(A): 1186, 2007.
- C-reactive protein changes during Perio Protect treatment of periodontal disease, C. Steele, B.J. Sindelar, and D.C. Keller, J Dent Res 86(A): 1195, 2007.
What are the American Academy of Periodontology’s concerns regarding the marketing of this product
The Academy has concerns about the promotional claims for the efficacy of this product and believes that they could be misleading to dentists and patients. The Academy is unaware of any randomized, controlled clinical trials evaluating the efficacy of the therapy that have been published in a peer-reviewed scientific journal with a generally accepted scholarly reputation.
What action has the Academy taken regarding this product
The Academy’s approach has been multi-faceted.
- In July 2004, the Academy advised Perio Protect of its concerns that the company’s marketing claims were inconsistent with the FDA 510(k) approval of the product.
- In September 2004 the Academy urged the FDA to evaluate promotional materials for Perio Protect®. Subsequently, Perio Protect revised and substantially reduced its claims regarding the efficacy of the product. The Academy has continued to monitor this product and recent review of promotional materials indicates that they are consistent with the FDA 510(k) approval. Nonetheless, the Academy remains concerned that there is no evidence in the peer-reviewed literature to support the revised claims.
- In March 2009, the Academy sent a letter to the FDA requesting an investigation into Perio Protect®‘s promotional materials and possible regulatory action against Perio Protect® for its possible violation of 510k approval.
- The Academy developed this fact sheet to assist members in understanding Academy concerns related to the promotion of this product.
- The Academy will continue to monitor promotional claims made by Perio Protect LLC.
As a Board Certified Periodontist, I am insulted by the audacity of this company to mislead dentists and their patients into thinking that an expensive gel filled tray will be of any significant benefit in the treatment of gum disease. There are books dedicated to the etiology and pathogenesis of gum disease: Click here for an example. Periodontal disease is a very complex disease in which bacterial plaque begins a complicated cascade of events that leads to alveolar bone and periodontal connective tissue destruction. Bacteria induce tissue destruction indirectly by activating host defense cells, which in turn produce and release mediators that stimulate the effectors of connective tissue breakdown. The end result is tooth loss. Here is a picture of what I see everyday in my practice.
Periodontal Destruction
A tray filled with gel cannot fix this or any other periodontal problem. I would encourage any dentist using this product to stop. It is not FDA approved and is not the standard of care.
If you enjoyed this article, there is a good chance you will like this:
Thanks for reading !!
20 Responses to “The Perio Protect® Scam”
I received an interesting comment from the president of Perio Protect®, Dr. Duane Keller. You can view his comment here:
http://www.wtnperioblog.com/meet-dr-todd-welch-2/
The comment was: “Albert Einstein said it best: “Condemnation without investigation is the height of ignorance.”
I would say to Dr. Keller that I was thinking the same thing when writing this blog post on this product. Perio Protect® has no validity, peer-reviewed double blinded research and minimal value to patients with periodontal disease. I extend an invitation to Dr. Keller to come to my practice and discuss our disagreement on his product. He is also welcome to observe the periodontal disease process at its highest level by viewing a periodontal surgery. I doubt he has ever seen a periodontal surgery unless he was fortunate enough to observe one in dental school. My point is that by simply applying a gel filled tray and having patients wear this tray does not treat or manage periodontal disease. As my blog post clearly states, periodontal disease is a very complex disease that deals with host modulation, host defense cells, cell mediators, and connective tissue and alveolar bone destruction.
Dr. Keller, you are free to call me anytime to discuss our disagreement, but to randomly post a quote from Albert Einstein is not the beginnings of a professional discussion of the topic. I hope you take me up on my invitation. If not, then I guess we can agree to disagree.
Sincerely,
Todd A. Welch, DMD
Diplomate of the American Academy of Periodontolgy
Dr. Welch, you have put a fine point on the nagging hesitation that I’ve been feeling about implementing the Perio Protect regimen in our general practice. But what do you offer patients who refuse a periodontist referral? This seems like a good alternative, however, your investigation seems to poke holes in the product’s claims.
Thank you so much for posting this article to DentalTown – it is how I found your blog, and so I wanted to stop by and show my appreciation.
Dr. Walraven,
Thank you for your comments and for taking the time to read the blog post. As you and I both know, many patients simply refuse specialty care. What I always tell my referring doctors is to implement a shorter periodontal maintenance regimen. It takes 3 months for periodontal pathogens to colonize and begin the destructive process. Thus, the 3 month cycle. Secondly, I always recommend re-emphasizing proper oral hygiene routines. Brushing and flossing 3 times per day works wonders for patients. Standard of care starts there and then with a referral to a periodontist. Document the referral in your clinical notes. Periosat can also be considered since it works at the host modulation level. I would also recommend at least 1 scaling and root planing visit per year. Therefore, the patient would have 3 regular dental cleanings and 1 full mouth scaling and root planing appointment. The point of my post is to emphasize the fact that the basics of dentistry should never be forgotten. Products such as Perio Protect® are nothing more than marketing ploys with zero peer reviewed research to back up their clinical claims. I hope his helps. Please comment anytime and I will be happy to answer any question you may have.
On a side note, Dental Town has threatened to remove me from their site for this post because they state that I cannot make posts that have links to my other posts. I find this ridiculous, yet interesting. If Howard Farran (owner of Dental Town) would like to contact me about this he is welcome to as well. They know where to find me.
Sincerely,
Todd
Periostat has fallen off the radar for the most part in many GP offices so I find it intriguing that you’re still recommending it. And I’m certainly looking forward to Dr. Keller’s response to your concerns with Perio Protect.
As for Dentaltown, I too have noticed that they are vigilant about stamping out anything that points outside of itself, but they do so understandably. It takes a town to raise a bubble, which means for us, bubble-popping bloggers, unite! (yes, i wanna be startin’ somethin. Oops, just did, yesterday. see over at dentalbuzz). Now you can ban me as well.
Dentaltown.com prides itself on being the number one site in the world for dental professionals to interact and learn. Our Message Boards are the most active and relevant discussions regarding dentistry today. In order to keep the discussion productive and interactive, we do require, like the vast majority of other sites, that our members adhere to a Terms of Use, which prohibits posts that do nothing but promote a particular members agenda. We can appreciate that some members take longer to recognize this kind of self-promotion and do offer warnings with guidance on how to use the forums appropriately.
Should anyone wish to discuss the policies of Dentaltown.com further, please feel free to contact me. You (apparently) know where to find us, as well.
Kerrie,
Thank you for your response and for the sarcasm and unprofessionalism at the end of your comment. I understand that Dental Town is the #1 site in the world for dental professionals to interact and learn. Are you a dentist? Have you ever held a handpiece, a bur, or blade? If so, you would understand that half of the talk on your #1 rated message boards is not based on peer reviewed research. That is what I thought I was going to bring to the board. I could care less how many hits I get on my site. Although, I do hope to gain advertisers so that I can donate the proceeds to deaf research.
What you and most people don’t know is that I am hearing impaired. The goal of my blog is to bring the most advanced, interesting, and newest technological advancements in the field of dentistry to dentists and patients. I have no intentions of becoming the “#1″ site in the field of dentistry. I hope to grow my blog so that I can help individuals with hearing handicaps as myself. I apologize if I offended the “#1″ dental site in the world. It would be nice if the “#1″ dental site in the world could donate some of its “1″ cash to a worthy cause for the hearing impaired.
You know where to find me if you decide to do so.
Sincerely,
Todd A. Welch, DMD
Diplomate of The American Academy of Periodontology
Dr. Welch,
My response was not meant to be sarcastic or unprofessional. I am not a Dentist, nor have I ever claimed to be. Our Message Boards aren’t meant to be used as a substitute for research, but as a discussion forum without Spam. If you truly want to use Dentaltown.com to grow your blog, please feel free to contact me and I will help you, as I have many dental professionals, do so in manner that adheres to our Terms of Use.
Good luck in your endeavors.
Dr. Welch. I am a dentist and feel that it is quite presumptuous for you to assume that you are the only one that contributes to charity. You have no clue what Howard Farran, Kerrie Kruse, myself, or anyone from Dentaltown contributes. Furthermore I personally have sent you numerous emails explaining how you were breaking the rules of decorum on Dentaltown and offered to help you. Now too has Ms Kruse. Yet you ignore our efforts. Those rules by the way are rules that you agreed to abide by when you signed on to Dentaltown. Now apparently you feel that you do not need to abide by them because you are charitable. You can very easily copy your posts here and post on Dentaltown if you desired. But we do not allow self promotion the way that you do it. If you decrease t be fair, Kerrie or I are both here to help you.
Regards
Howard Goldstein
Message Board Manager
http://WWW.Dentaltown. com
Howard,
I have received every one of your emails telling me how to post on the boards and I have done exactly what I have been told to do and have still been banned. I agree that I did not comply at first, but I changed the way I posted on your boards. I simply copy and paste my blog posts. I could care less about self promotion. My blog is not a business, my periodontal practice is what I do for a living. My blog is something I due to give back to dentistry and hopefully in the future to help my charity. I congratulate you for being the #1 dental forum in the world. I would however ask that you reconsider your posting criteria. It wouldn’t hurt the #1 dental forum in the world to have some posts that actually have some peer reviewed research instead of simply clinical trial and error.
I do find it humorous that the #1 dental forum in the world would take the time to post on my blog.
I will take that as a compliment.
Regards,
Todd
PS: To all dental bloggers: If you don’t want to get banned from Dental Town (which I could really care less about), don’t post any type of link to your blog on a post on their site or make a blog post about any product that may advertise on Dental Town. By the way, there are several other very good dental blog sites on the internet: webdental and dentinaltubules just to name two. Also, there are now groups on facebook and linkedin where you can post whatever you want without having a non-dentist moderate your every post.
Dear Dr. Welsh,
Thank you for your invitation to Duane Keller to visit your practice. Dr. Keller has a very heavy teaching schedule in addition to his full-time private practice so an online forum may be a better way for you to discuss the benefits and limitations of the Perio Protect Method. If you are genuinely interested in a full investigation of the Method, please contact me to make arrangements.
I would start by sending you microbiology reports authored by Dr. Christoph Schaudinn and Dr. Bill Costerton, the 2009 CR report, and preliminary research results from a multiclinic study. I can also send you a full explanation of the misleading statements from the AAP that you have recently cited.
Given your hostility to Perio Protect methodology, I assume there is a misunderstanding about the purpose of delivering chemical debriding agents into periodontal pockets with a custom-fabricated tray. This adjunctive therapy that can be done by patients between office visits seeks the same aims as mechanical debridement. Subgingival calculus must still be treated with professional cleaning procedures and granulomatous tissue must still be removed by surgical means. Periodontists are some of the biggest prescribers of the trays and medication, which are often used in conjunction with surgery either to help reduce the scope of the surgery or to maintain post surgical gains.
Clearly peer-reviewed, blinded research studies help create the standard of care. As you can appreciate, this research takes a lot of time and resources to complete. It is in process. It is fair to reserve judgment until that research is published, but it is not the only kind reliable evidence. It is not fair to dismiss a therapy that has clearly benefitted tens of thousands of patients without fully investigating it. I would appreciate the opportunity to share data with you if you are willing to engage in a dialogue that is measured and fair-minded.
Sincerely yours,
Tanya Dunlap, PhD
Program Development Director
Perio Protect, LLC
Dr. Dunlap,
Thank you for your response. You are the only person that has posted in a cordial manner. I would be happy to review the literature. You can email it to me at welchdmd@hotmail.com.
Thank you for your comment,
Todd Welch, DMD
Dear Dr. Welsh,
I will email the literature to you today. Digital transmission of Clinician’s Report on the Perio Protect Method is prohibited and will be mailed to your office via USPS. I will also send you a link to watch a recorded webinar with microbiological research results of chemical debridement evidenced with the Molecular Probe live/dead system. After you have an opportunity to review the documentation, please contact me again if you would like additional information or have questions.
In brief, the Perio Protect Method is a comprehensive approach to periodontal disease combining mechanical and laser therapies with a customized tray delivery of chemical debriding agents into periodontal pockets to help manage oral biofilm between office visits. Patients describe the tray as comfortable and appreciate the non-invasive adjunctive option.
Until you have had time to review this documentation, I would appreciate your reconsideration of the disparaging word “scam” above and respectfully ask you to remove it from your blog. We are passionate about excellent oral health care and are working hard to help dentists help patients.
Sincerely,
Tanya Dunlap
Program Development Director
Perio Protect, LLC
Dr. Welch,
My apologies for misspelling your name in the last post!
Tanya Dunlap
Dear Dr. Welch,
Below is a reply explaining the errors in the AAP Fact Sheet that you have published on this blog.
I noticed that you changed the word “Scam” to “Deception” on your blog. While I appreciate the removal of the offensive Scam, the new reference to deceit violates the understanding I thought we had for measured and fair-minded dialogue. It continues to disparage our company and specifically Dr. Keller who has worked his entire life to help his patients. I respectfully ask you to remove the disparaging commentary from this blog. If you refuse to do so, I can only assume that you do not value this honest, professional exchange.
Sincerely,
Tanya Dunlap
A Reply to the AAP Fact Sheet
The Perio Protect Method® should not be confused with the Perio Tray®. The Perio Tray is simply a prescription device that can be used in a comprehensive treatment plan to allow a dentist to prescribe medications that can be delivered by a patient to the periodontal pocket. Perio Protect methodology combines mechanical or laser treatment of subgingival biofilm with an adjunctive chemical therapy used to alter the microbiological environment of the sulcus and disrupt biofilm growth. Any detailed treatment plan for this combined and customized approach to treat individual patients is part of the practice of dentistry and left to the discretion of the treating dentist.
Although the dentist determines the most appropriate solutions for individual patients, the most commonly prescribed solution with the Perio Protect Method is a low concentration of hydrogen peroxide for its known use as an oral debriding agent. A low concentration of hydrogen peroxide can be delivered with a prescription dental tray cleared by the FDA, such as the Perio Protect device, trademarked as a Perio Tray®, which was cleared by the Food and Drug Administration through its 510(k) premarket notification process under 21 U.S.C. sec. 360(k).
The 510(k) process is the mechanism used to allow the marketing of roughly 98% of all devices that FDA reviews. Virtually all new dental devices enter the U.S. market through 510(k) premarket notifications. While this notification is not technically called an “approval” but a “clearance,” the effect is exactly the same — the device is reviewed by FDA and allowed onto the market.
During the 510(k) process, the FDA determines whether a product is “substantially equivalent” to another device. The term “substantially equivalent” has a very specific statutory meaning. Two devices can be quite dissimilar and still “substantially equivalent” for purposes of a 510(k) review. The fact that the Perio Tray was found substantially equivalent to a disposable fluoride tray is irrelevant to the intended use or clinical value of the device. Put another way, the fact that the Perio Tray was found substantially equivalent to a fluoride tray has no bearing on the clinical performance of the Perio Tray.
To decide whether a device is substantially equivalent, the FDA reviews the submission and the supporting data. If the FDA believes that the data does not support the clearance of the device, it will find the device “not substantially equivalent,” i.e., in effect reject the device. Many devices are found “not substantially equivalent” because they lack the supporting data. In this case, the FDA found that the Perio Tray met all the statutory requirements. It is cleared as a prescription medical device with specialized seals and extensions that are manufactured in a laboratory registered with the FDA to fabricate the medical device. To the extent the AAP document belittles the FDA process and implies that a 510(k) clearance carries no weight or that the Perio Tray is merely a disposable fluoride tray, the document is without merit.
The set of AAP bullet points under the heading “What We Know” is particularly disingenuous. In the first bullet point, the AAP fails to tell the entire story when, in effect, the AAP suggests that the Perio Tray is nothing more than a fluoride tray used to prevent tooth decay. The AAP conveniently fails to mention that the FDA, in connection with issuing the 510(k) clearance for the tray, also found that: “The design of the Perio Protect Tray permits placement of solutions deeper in the [periodontal] crevice/pocket than is possible with traditional fluoride trays.” In other words, the Perio Tray can perform an entirely different function than a typical fluoride tray, a function that allows medications in the tray to be placed in the pockets, the sites known to harbor bacterial infections associated with periodontal disease.
The document also states that the AAP “is unaware of any randomized, controlled clinical trials evaluating the efficacy of this therapy that have been published in a peer-reviewed scientific journal with a generally accepted scholarly reputation.” The AAP revised this statement to include the words “randomized, controlled clinical trials” after Perio Protect, LLC challenged the AAP’s previous publications stating that their leadership was “not aware” of any published research when, in fact, the AAP referenced such research on its own website where Academy members, not consumers, have access.
Despite the fact that randomized controlled clinical trials are underway, the emphasis on such trials implies that they are the only evidence of the efficacy of a treatment methodology. That implication is simply misleading. Furthermore, failing to disclose research and publications gives the public and the profession an unfair picture of the scientific support for the Perio Protect Method.
The final AAP bullet point is the most egregious example of misinformation. The AAP states: “Numerous clinical studies have suggested that topically applied medicines do not reach the source of periodontal infections.” Not only has the Perio Tray never been mentioned in any such clinical study, but the AAP statement itself totally ignores the FDA finding in the 510(k) clearance, that is, that the Perio Tray “permits placement of solutions deeper in the [periodontal] crevice/pocket than is possible with traditional fluoride trays.” In other words, the unique design of the Perio Tray does, in fact, permit medications to be placed into periodontal pockets, the opposite of what the AAP statement suggests.
Dr. Dunlap,
I reviewed the one research paper you emailed. After spending 3 years in my post-doctoral residency devoted to periodontology, we spent every week reading at least 30 peer reviewed unbiased research papers on the pathogenesis of periodontal disease. The paper you sent me did not sway my opinion of your product. I have a few questions: 1) Who funded the research? If it was funded by Perio Protect or someone related to the product, then our discussion should end there. 2) In the poster presentation you sent me, it stated that the Perio Protect Method treated all forms of periodontal disease. This is simply not true 3) I am judged on a daily basis by general dentists on the quality of my work and the quality of my dental implant placement. Why is that a company, such as Perio Protect, cannot come under the same scrutiny with only one research paper to back its claims?
Todd A. Welch, DMD
Diplomate of The American Academy of Periodontology
Dr. Welch,
Before additional materials were to be sent to you, I had asked you to confirm receipt of the initial large files so as not to duplicate my efforts. I never received your confirmation thus additional files were not sent.
I had extended this exchange of information as a courtesy to you. Your hostility continues as does your disparagement. At this point, if you want all the research and scientific evidence, which takes several hours to present, please attend a Perio Protect course. If you genuinely believe that the quality of your treatment depends on the outcomes for your patients, the course will also give you every opportunity to scrutinize cases.
Tanya Dunlap
Dr. Dunlap,
You still did not tell me who funded the research. It is a simple question.
Todd A. Welch, DMD
Diplomate of The American Academy of Periodontology
Dear Dr Welch
I have found the conversations here very stimulating . This is a very interesting view point. Considering that this conversation has both your point of view and the point of view from a representative from Perio Protect would you be happy if I reproduced this blog on our dental website (which you are aware about and a regular contributor to ?)
As a balance, would the representative from Perio Protect be able to offer their point of view ?
Perhaps if either of both of you are happy, we can open up the discussion on our dental website
Thanks
Dhru
No reply ?
Dr. Dunlap,
If you are such an authority in the pathogenesis of periodontal disease, may I ask what your field of study was for your PhD. Also, may I ask who your dad is. I would appreciate it if you could answer these questions for me. My guess is that you won’t.
Dr. Welch