An observational study in Dental Caries and Caries Risk, sponsored by October University for Modern Sciences and Arts. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by October University for Modern Sciences and Arts · Observational
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. Systematic evidence has shown that these validated models provide acceptable discriminatory ability and calibration for identifying individuals at increased risk of developing dental caries. Furthermore, recent evidence synthesizing longitudinal cohort studies has identified a consistent set of adult caries risk factors, including smoking, systemic diseases, water fluoridation exposure, educational level, fluoride toothpaste use, dietary sugar intake, bacterial plaque accumulation, and previous caries experience. These established determinants are comprehensively represented within the nine domains of the DCRQ, supporting its content validity. In addition, previous validation studies of simplified questionnaire-based caries risk assessment instruments have demonstrated acceptable internal consistency, good test-retest reliability, and significant associations between increasing risk categories and objective clinical indicators such as DMFT scores, plaque accumulation, white spot lesions, and active cavitated lesions. Collectively, these findings support the use of a cross-sectional diagnostic agreement design in which questionnaire-derived risk classification is evaluated against an established clinical risk assessment protocol and validated using objective measures of cumulative caries experience.
The study will be conducted at the Dental Outpatient Clinic, Faculty of Dentistry, MSA University (October University for Modern Sciences and Arts), 6th October City, Cairo, Egypt. Consecutive sampling will be employed on designated study days to minimise selection bias, consistent with STARD 2015 recommendations for diagnostic accuracy studies.
Adults aged 18 to 65 years.
Presence of acute dental pain or a dental emergency requiring immediate treatment at the time of enrollment.
Diagnostic Test: Digital Caries Risk Assessment
The Digital Caries Risk Questionnaire (DCRQ) is a patient self-administered digital instrument encompassing nine weighted risk domains: (1) disease indicators and dental history; (2) dietary and lifestyle habits; (3) oral hygiene practices and fluoride use; (4) salivary and gingival health; (5) medical conditions; (6) current medications; (7) water source and fluoride exposure; (8) tobacco and nicotine use; and (9) clinical symptoms. Each domain generates a weighted subscore; domain scores are summed to yield a total score (maximum 160 points), with predefined override rules applied to prevent underestimation of risk in participants presenting with strong disease indicators (e.g., multiple restorations, root canal treatments, or persistent dental pain), ensuring clinically appropriate classification regardless of total score. The total score maps to one of four ordered risk categories: Low (0-39), Moderate (40-79), High (80-119), and Very High (120-160).
Cohen's weighted kappa
The primary outcome is Cohen's weighted kappa (κw) with quadratic weights, computed between DCRQ and CAMBRA 4-level classifications (Low / Moderate / High / Very High). Both instruments share a 4-tier structure; no category collapsing is required. Minimum acceptable agreement: κw ≥ 0.41 (lower bound of 95% CI), corresponding to moderate agreement per Landis and Koch (1977). The 95% CI will be computed by bootstrap resampling (2,000 iterations).
Time frame: Baseline (single study visit)
Diagnostic accuracy of the Digital Caries Risk Questionnaire (DCRQ) for identifying participants with high cumulative caries experience (DMFT ≥ 4).
Diagnostic accuracy will be evaluated by calculating sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) using DMFT ≥ 4 as the reference standard.
Time frame: Baseline (single study visit)
Discriminative ability of the DCRQ for identifying participants with high cumulative caries experience.
Receiver operating characteristic (ROC) curve analysis will be performed to determine the area under the curve (AUC) and the optimal DCRQ score cut-off for predicting DMFT ≥ 4.
Time frame: Baseline (single study visit)
Independent predictors of high cumulative caries experience.
Multivariable logistic regression will be used to identify independent predictors of DMFT ≥ 4 and estimate the contribution of each DCRQ domain after adjustment for relevant covariates.
Time frame: Baseline (single study visit)
Internal consistency of the DCRQ.
Internal consistency reliability will be assessed using Cronbach's alpha coefficient.
Time frame: Baseline (single study visit)
Test-retest reliability of the DCRQ.
Test-retest reliability will be assessed using the intraclass correlation coefficient (ICC) in a nested subset of 60 participants who complete the DCRQ on two occasions separated by a 14-day interval.
Time frame: 14 days after baseline
Performance of the DCRQ across participant subgroups.
Diagnostic performance and agreement of the DCRQ will be evaluated according to age, sex, educational level, and smoking status.
Time frame: Baseline (single study visit)
Plan to share: Undecided
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October University for Modern Sciences and Arts