Background: A recent symposium jointly sponsored by the NIDCR and industry, highlighted the need and opportunity for validation of new technologies that might be used to measure tooth surface demineralization as an end point in dental clinical trials. This approach could greatly facilitate clinical assessment of new methods for preventing and reversing early demineralization to reduce or eliminate progression to cavitated carious lesions. Some of the technologies that may be useful in assessment of early and reversible tooth surface demineralization include fiber-optic transillumination, digital imaging fiber-optic transillumination (DIFOTI), electrical conductivity measurement, quantitative laser fluorescence (QLF), alternating current impedance spectroscopy, multi-photon imaging, infrared thermography, infrared fluorescence (IR), optical coherence tomography (OCT), ultrasound, and terahertz imaging (ICT-CCT, 2004).
Current Portfolio Overview: The NIDCR research portfolio includes only a few studies that are focused on the adaptation and validation of imaging technologies such as QLF, IR, DIFOTI, and OCT for the assessment of tooth surface demineralization. One study in the Small Business Innovative Research (SBIR) Program aims to develop instrumentation for dental diagnosis using ultrasound and pattern recognition software.
Relevant Recommendations From Workshops:
2001 NIDCR Consensus Development Conference “Diagnosis and Management of Dental Caries Throughout Life”:
- Assessment of the validity of newer diagnostic methods of caries is necessary.
2002 International Consensus Workshop on Caries Clinical Trials (Pitts & Stamm, 2004):
- For future clinical trials, recording only cavitated lesions as an outcome measure is becoming outmoded.
- The assessment of non-cavitated lesions is essential for future caries clinical trials, and new caries assessment methods have the prospect of helping in this task.
- Given the deficiency of current ‘gold standards’, and the challenges of achieving appropriate validation, new reference standards and validation protocols should be developed.
- In vitro and/or in situ studies to validate methods of caries detection are required to develop and evaluate new diagnostic techniques.
- New technologies should be further refined and adopted in modern caries clinical trials if they demonstrate the ability to improve trial outcomes, reduce subject numbers, and/or reduce costs.
Collaborative Activities: The validation of the various imaging technologies requires partnerships with industry. It is recommended that this initiative be developed in partnership with industry and that the FDA be consulted.
Funding Mechanisms: To be determined.