Condition: Dental Caries · Caries Risk · Sponsor: October University for Modern Sciences and Arts
This study is designed as a cross-sectional diagnostic agreement study conducted in accordance with the Standards for Reporting Diagnostic Accuracy Studies (STARD 2015) and the Guidelines for Reporting Agreement and Precision of Patient-reported Assessments (GRAPPA). The study evaluates the diagnostic agreement between the Digital Caries Risk Questionnaire (DCRQ), a novel patient self-administered digital instrument, and the Caries Management by Risk Assessment (CAMBRA) protocol as the primary clinical comparator. The Decayed, Missing, and Filled Teeth (DMFT) index is used as the reference standard for cumulative caries experience, with a threshold of DMFT ≥ 4 to identify individuals with high caries experience. Although the DMFT index reflects previous disease experience rather than future disease risk, it provides an objective clinical outcome for assessing construct validity. Accordingly, CAMBRA serves as the primary comparator for risk classification, whereas the DMFT index supports validation by evaluating the relationship between questionnaire-derived risk categories and cumulative clinical disease burden. The methodological rationale for this study is based on the current evidence supporting contemporary caries risk assessment models. CAMBRA is recognized as one of the most extensively validated and widely implemented caries risk assessment systems and has demonstrated diagnostic performance comparable to other internationally accepted risk assessment models. Systemat…
This description comes directly from the study's public registry record.
Shereen Assem El Sherif, Dr. · +201066668112 · selsherif@msa.edu.eg
Nermeen Kamal Hamza, Professor · +201211110660 · nhamza@msa.edu.eg
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| October University for Modern Sciences and Arts | Giza, Sixth of October, Egypt | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07716254