Perio Protect®—What You Should Know
Facts from the AAP regarding a tray delivery device marketed for the treatment of gum disease.
American Academy of Periodontology is an advocate for the periodontal and general health of the public and promotes excellence in the practice of periodontics. As the recognized authority in the specialty of periodontology, the AAP is an information resource regarding new and emerging technologies used to diagnose and treat periodontal diseases. We invite you to browse Perio.org for more information on periodontal diseases and their treatments. The Academy also encourages you to speak with your periodontist or dentist for more information regarding your risk for being affected by these chronic inflammatory conditions.
Recently, questions have been raised in regards to the Perio Protect® tray, a product marketed for the treatment of gum disease. The following fact sheet aims to set forth some facts regarding this product.
What is Perio Protect®?
The Perio Protect® device is a custom-fit tray made by a specialized dental laboratory from impressions of the patient’s mouth taken by a dentist. The medications placed in the tray are determined by the dentist.
What We Know
- The Perio Protect® tray was cleared for marketing by the Food and Drug Administration (FDA) on grounds that it is substantially equivalent to a previously marketed disposable fluoride tray. This type of tray is traditionally used to prevent tooth decay.
- The FDA clearance process did not determine that the Perio Protect® tray has been proven to be a safe or effective modality for the treatment of gum disease.
- The Academy 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.
- Numerous clinical studies have suggested that topically applied medicines do not reach the source of periodontal infections.
*Note: Peer-reviewed journals publish articles that have been reviewed by experts in the field. The peer-review process is intended to support publication of relevant findings and acceptable interpretations, while guarding against publication of unwarranted claims and personal views. Professionals look to the peer-review process to support solid scholarship in their field or discipline.