Even though some instruments and methods exhibited good to excellent reliability and validity and can be recommended for research and clinical practice , they do not allow assessing all components of physical oral health .
OBJECTIVE This study aim ed at exploring available clinical instruments and methods for assessing physical oral health , and at identifying those with sufficient diagnostic performance .
Improving detection of precancerous and cancerous oral lesions. Computer-assisted analysis of the oral brush biopsy. U.S. Collaborative OralCDx Study Group.
BACKGROUND A study group composed of research ers from across the United States undertook a study to evaluate the sensitivity and specificity of OralCDx ( OralScan Laboratories Inc. ) , a computer-assisted method of analysis of the oral brush biopsy , in the detection of precancerous and cancerous lesions of the oral mucosa . METHODS The study group conducted a multicenter double-blind study comparing results of OralCDx analysis with those of scalpel biopsy of suspicious oral lesions , as well as using OralCDx on oral lesions that appeared benign clinical ly . RESULTS In 945 patients , OralCDx independently detected every case of histologically confirmed oral dysplasia and carcinoma ( sensitivity = 100 percent , false-negative rate = 0 percent ) . Every OralCDx " positive " result was subsequently confirmed by histology as dysplasia or carcinoma . The specificity for the OralCDx " positive " result was 100 percent , while the specificity for the OralCDx " atypical " results was 92.9 percent . In 4.5 percent of clinical ly benign-appearing lesions that would not have received additional testing or attention other than clinical follow-up , OralCDx uncovered dysplasia or carcinoma ( statistical sensitivity > 96 percent , P < .05 , n = 131 ; statistical specificity for the OralCDx " positive " result > 97 percent and for the " atypical " result > 90 percent , P < .05 , n = 196 ) . CONCLUSIONS The authors propose that this multicenter trial demonstrates that OralCDx is a highly accurate method of detecting  oral precancerous and cancerous lesions .  OralCDx can aid in confirming the nature of apparently benign oral lesions and , more significantly , revealing those that are precancerous and cancerous when they are not clinical ly suspected of being so . All OralCDx " atypical " and " positive " results should be referred for scalpel biopsy and histology to completely characterize the lesion . CLINICAL IMPLICATION S Given the difficulty in clinical ly differentiating premalignant and malignant lesions from benign lesions with a similar appearance , OralCDx appears to determine the significance of an oral lesion definitively and detect innocuous-appearing oral cancers at early , curable stages
Even though some instruments and methods exhibited good to excellent reliability and validity and can be recommended for research and clinical practice , they do not allow assessing all components of physical oral health .
OBJECTIVE This study aim ed at exploring available clinical instruments and methods for assessing physical oral health , and at identifying those with sufficient diagnostic performance .