The focus of this funding opportunity announcement (FOA) is to encourage the development of devices that will improve diagnosis of the following oral diseases and conditions: 1) caries after the appearance of white spot lesions and before penetration through the enamel-dentin junction; 2) severity and status of periodontal disease; 3) cracks in teeth and the depth of their extension into the tooth; and 4) level of pulp vitality. The developed devices must be accurate, reliable, and generate reproducible data.
The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to improve oral, dental and craniofacial health through research. The objective of this initiative is consistent with the NIDCR Strategic Plan 2014-2018, Objective I-5. Facilitate reconstruction and regeneration of diseased or damaged oral and craniofacial tissues and organs through biological, bioengineering and biomaterials research approaches. During the last decade, researchers supported by NIDCR have focused on developing more accurate and reproducible methods to diagnose dental caries, and to determine if carious lesions are active or inactive. These methods could provide practitioners with additional information so they can choose to treat caries either surgically or with preventive agents. In 2005, NIDCR funded several projects submitted in response to RFA-DE-06-008, Validation of New Technologies for Clinical Assessment of Tooth Surface Demineralization. These projects focused on the development of devices for early diagnosis of carious lesions. Approaches supported by the 2005 FOA included technical methods, OCT or IR, in conjunction with Raman spectroscopy to determine caries activity, mainly in occlusal or facial lesions. At present, these new methods require expensive devices and are not ready for use in a dental operatory. Other new caries detection devices on the market detect only smooth surface lesions, and utilize fluorescence of enamel (green emission) and the presence of porphyrin from oral bacteria (red emission) as the basis for caries detection. Evidence supporting this approach for caries detection is limited. Review of the literature suggests that these devices may be used as an adjunct to the standard clinical diagnostic evaluation (visual/tactile/radiographic examination), while some publications indicate that these devices add no value to the current standard diagnostic method.
The diagnosis of periodontal disease continues to rely on the probing of periodontal pockets and the radiographic assessment of alveolar bone height and loss. However, these diagnostic techniques have weak predictive value in determining current disease activity and appropriate future treatment. While new periodontal diagnostic strategies are likely to include the identification of biomarkers that are indicative of current disease activity and predictive of future disease progression, novel devices for diagnosing periodontal disease could involve imaging technologies capable of accurately measuring subtle changes in periodontal attachment levels or alveolar bone integrity.
Another area that needs improved diagnostics is an accurate three dimensional representation of cracks in teeth. The ultimate goal is to have a system that would predict which cracks will lead to fracture of the tooth and which cracks are arrested and unlikely to progress. Additional clinical needs include methods to measure pulp vitality, such as using a miniature coil for MRI analysis of pulp status and oximetry to determine pulpal perfusion. Any new imagining diagnostic will require clinical studies tailored to the expected clinical use to establish and validate the diagnostic efficacy, reliability and reproducibility while not increasing health risks for patients.
In addition, NIBIB is dedicated to improving health by leading the development and accelerating the application of biomedical technologies (http://www.nibib.nih.gov/About). The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. Specific topics that would be appropriate to this FOA and of interest to NIBIB include, but are not limited to: 1) development of multimodal, multiplexed or multiscale imaging technologies and contrast agents, 2) development and evaluation of integrated biomodulation and theranostic technologies, 3) the fusion and analysis of imaging data, clinical data and genomic data for better decision-making and 4) development of appropriate technologies for pediatric patients, reducing ionizing radiation exposure, unnecessary use of diagnostic imaging and reduction of medical errors. It is expected that improved diagnosis of dental diseases and conditions will provide earlier detection, more accurate diagnosis, earlier application of preventive modalities of treatment, differentiation of active versus inactive disease states, avoidance of over treatment, and an overall improvement in the oral health of the general public.
This FOA will not accept clinical trial applications. Applicants who wish to conduct clinical trials must use the R34 or U01 mechanism under the NIDCR Clinical Trials Program (see http://www.nidcr.nih.gov/Research/DER/ClinicalResearch/ClinTrials.htm).