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. 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.
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.