We thank Dr. Huber for his letter. The purpose of our survey was to assess the standards of care in diagnosis and management at the time the survey was conducted. We believe this article is a first step in examining current standards of care and, potentially, a beginning in developing management guidelines.
As we noted in the article, the survey was conducted before the U.S. Food and Drug Administration’s (FDA’s) "clearance" of some of the devices that have been subsequently cleared, making these available for clinical use. As Dr. Huber notes, FDA clearance of devices can be based on predicate devices, where substantial equivalency is shown and safety is not identified as a concern. The provider must be aware that device clearance is not equal to the stringency of drug approval.
We agree that recommendations for use of the available adjuncts are needed in the community. We also agree that recommendations for use of adjuncts in diagnosis may have different outcomes in different patient populations and with different providers. A systematic review of current studies has been undertaken to assess the utility of adjuncts in detection and diagnosis and, when completed, may provide additional guidance.
While there is increasing evidence being developed through continuing studies, more study needs to be done in the clinical environments in which they are anticipated to be applied. Organizations should develop guidelines based on the best available data and develop and promote guidelines for oral health care providers in the best interests of our patients. Our survey and Dr. Huber’s letter point to the need for continuing research and development of guidelines in detection, diagnosis, intervention and follow-up of oral premalignant lesions that falls within the scope of dentistry.
