Opportunity Information: Apply for PA 15 336

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked Teeth, and Pulp Vitality) (R41/R42)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121 Oral Diseases and Disorders Research 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health.
  • This funding opportunity was created on Aug 20, 2015 and posted on Aug 20, 2015.
  • Applicants must submit their applications by Sep 7, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
  • Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:

This funding opportunity, titled "Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked Teeth, and Pulp Vitality) (R41/R42)," is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) grant program designed to push promising dental imaging diagnostics closer to real-world clinical use. The overall goal is to speed up the advanced development, validation, and implementation of imaging-based diagnostic devices that can detect common and clinically significant dental problems more accurately than what is typically used in routine practice. The emphasis is on tools that are reliable and reproducible, and that achieve very high specificity and sensitivity, meaning they should correctly identify disease when it is present and avoid false alarms when it is not. Importantly, these advances must not come at the cost of greater health risks to patients, so safety and noninvasiveness (or at least risk neutrality compared to standard care) are central expectations.

The clinical targets are clearly defined: dental caries (tooth decay), periodontal disease, cracked teeth, and pulp vitality. These are areas where traditional diagnostics can be limited. For example, standard caries detection often relies on visual inspection, tactile probing, and radiographs, which can miss early-stage lesions, struggle with certain tooth surfaces, or yield ambiguous findings. Similarly, diagnosing cracks and determining whether the dental pulp is alive and healthy can be challenging with conventional chairside methods. This program is looking for technologies that can outperform these traditional approaches in a way that is practical for clinical workflows and credible in terms of clinical evidence.

A wide range of imaging and sensing approaches are considered responsive, and the announcement explicitly encourages innovation rather than restricting applicants to a single technology. Examples of approaches highlighted include optical coherence tomography (OCT), optionally combined with Raman spectroscopy; MRI image analysis methods; electrical conductivity measurement (ECM); quantitative laser fluorescence (QLF); alternating current impedance spectroscopy; multiphoton imaging; infrared thermography; infrared fluorescence; ultrasound; and terahertz imaging. The point of listing these is to show openness to both optical and non-optical modalities, as well as hybrid systems and advanced computational analysis. At the same time, the announcement makes it clear that entirely new modalities are welcome as well, as long as they can credibly demonstrate a pathway to improved diagnostic performance and clinical adoption.

From an administrative standpoint, this is a discretionary grant opportunity using the NIH STTR mechanisms R41 (Phase I) and R42 (Phase II). In practice, Phase I generally supports early feasibility work and proof-of-concept, while Phase II supports further development, refinement, and stronger validation needed for commercialization and clinical implementation. The eligible applicants are small businesses; non-U.S. (foreign) institutions are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are not eligible. However, foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some circumstances, which can matter for specialized collaborations or access to unique expertise or resources.

The opportunity is categorized under health-related research and aligns with CFDA numbers 93.121 (Oral Diseases and Disorders Research) and 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health). There is no cost sharing or matching requirement, which reduces barriers for small businesses that may not have large amounts of non-federal capital available. The opportunity was posted and created on August 20, 2015, with an original and final closing date of September 7, 2018, and it was archived on October 8, 2018. While archived opportunities are no longer accepting applications, the description still provides a useful snapshot of NIH priorities and the types of technical and clinical benchmarks expected for dental diagnostic imaging tools.

For applicants and developers, the core message is that NIH was seeking clinically meaningful diagnostic improvements, not just incremental engineering. The strongest projects under a program like this would be expected to show a realistic plan for demonstrating performance gains over standard-of-care diagnostics, to address reproducibility and operator variability (a common issue in chairside tools), and to consider how the device would be used in real dental settings. That includes practical considerations like scan time, ease of interpretation, integration with existing dental workflows, patient comfort, and regulatory and safety expectations. The full announcement was linked through the NIH grants page (PA-15-336), with support contacts provided through the NIH Office of Extramural Research (OER) webmaster channels for access or linking problems.

Frequently Asked Questions (FAQs)

What is the title of this funding opportunity?

The opportunity is titled "Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked Teeth, and Pulp Vitality) (R41/R42)."

What type of program is this?

This is a National Institutes of Health (NIH) Small Business Technology Transfer (STTR) funding opportunity using the R41 (Phase I) and R42 (Phase II) mechanisms.

What is the main goal of the program?

The goal is to accelerate the advanced development, validation, and implementation of imaging-based diagnostic devices for dental diseases and conditions, moving promising technologies closer to real-world clinical use.

Which dental conditions are specifically targeted?

The clinical targets are dental caries (tooth decay), periodontal disease, cracked teeth, and pulp vitality.

What kinds of improvements is NIH looking for compared to routine dental practice?

NIH is looking for imaging diagnostics that can detect these conditions more accurately than typical routine approaches, with strong emphasis on reliability, reproducibility, and very high specificity and sensitivity (identifying true disease while minimizing false alarms).

Why is there an emphasis on specificity and sensitivity?

Because the program prioritizes tools that both correctly identify disease when present (high sensitivity) and avoid incorrectly flagging disease when it is not present (high specificity), which is essential for clinically credible diagnostics.

Are safety and noninvasiveness important in this program?

Yes. The opportunity stresses that improvements in diagnostics should not increase health risks to patients. Safety and noninvasiveness (or at least being risk-neutral compared to standard care) are central expectations.

What diagnostic limitations in current dental practice is this program trying to address?

The description highlights limitations of conventional methods such as visual inspection, tactile probing, and radiographs for caries detection (which may miss early lesions or produce ambiguous findings), and notes that diagnosing cracked teeth and assessing pulp vitality can be challenging with standard chairside methods.

What types of imaging or sensing technologies are considered responsive?

The opportunity indicates openness to a wide range of imaging and sensing approaches, including optical and non-optical modalities and hybrid systems.

Which example technologies are explicitly mentioned?

Examples listed include optical coherence tomography (OCT) (optionally combined with Raman spectroscopy), MRI image analysis methods, electrical conductivity measurement (ECM), quantitative laser fluorescence (QLF), alternating current impedance spectroscopy, multiphoton imaging, infrared thermography, infrared fluorescence, ultrasound, and terahertz imaging.

Are applicants limited to the technologies listed?

No. The listed approaches are examples to show the program is open to multiple modalities. Entirely new modalities are also welcome if they can credibly demonstrate a pathway to improved diagnostic performance and clinical adoption.

What does "advanced development, validation, and implementation" imply for proposed projects?

It implies projects should move beyond basic concepts toward stronger development and evidence that supports clinical use, including plans to demonstrate diagnostic performance improvements over standard-of-care methods and to support real-world implementation.

What is the difference between Phase I (R41) and Phase II (R42) in this opportunity?

Phase I (R41) generally supports early feasibility and proof-of-concept work, while Phase II (R42) generally supports further development, refinement, and stronger validation needed for commercialization and clinical implementation.

Who is eligible to apply?

Eligible applicants are small businesses applying under the NIH STTR mechanisms.

Can a non-U.S. (foreign) institution apply as the applicant organization?

No. Non-U.S. (foreign) institutions are not eligible to apply as the applicant organization for this opportunity.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are not eligible.

Are any foreign collaborations allowed?

Potentially. The description notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowable in some circumstances, which can matter for specialized collaborations or access to unique expertise or resources.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement stated for this opportunity.

Which CFDA numbers are associated with this opportunity?

The opportunity aligns with CFDA 93.121 (Oral Diseases and Disorders Research) and CFDA 93.286 (Discovery and Applied Research for Technological Innovations to Improve Human Health).

When was this opportunity posted, and what were the closing dates?

It was posted and created on August 20, 2015. The original and final closing date was September 7, 2018.

Is this opportunity still accepting applications?

No. It was archived on October 8, 2018, and archived opportunities are no longer accepting applications.

What does it mean that the opportunity is "archived"?

In this context, "archived" means the solicitation is no longer open for submissions. The description can still be useful as a snapshot of NIH priorities and expectations for dental diagnostic imaging tools.

What kinds of project characteristics would be important for clinical adoption?

The opportunity emphasizes practical, real-world considerations such as reproducibility and operator variability, scan time, ease of interpretation, integration with existing dental workflows, patient comfort, and regulatory and safety expectations.

Is NIH looking for incremental engineering improvements or bigger clinical gains?

The program message emphasizes clinically meaningful diagnostic improvements rather than purely incremental engineering advances.

What funding opportunity announcement (FOA) identifier is referenced?

The full announcement is referenced as PA-15-336 on the NIH grants page.

Where were support contacts directed for access or linking problems?

The description notes support contacts through the NIH Office of Extramural Research (OER) webmaster channels for access or linking issues.

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