Validation of a Digital Caries Risk Assessment Questionnaire Against the CAMBRA Protocol in an Egyptian Adult Population

October University for Modern Sciences and Arts384 enrolled

Overview

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.

Interventions

Digital Caries Risk AssessmentDIAGNOSTIC_TEST

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Inclusion Criteria 1. Adults aged 18 to 65 years. 2. Egyptian nationals or individuals who have resided in Egypt for at least 5 years. 3. Able to read and understand Arabic or English. 4. Presence of at least 10 natural teeth. 5. Presenting for routine dental examination, preventive care, or treatment planning. 6. Able and willing to provide written informed consent. * Exclusion Criteria 1. Presence of acute dental pain or a dental emergency requiring immediate treatment at the time of enrollment. 2. Severe cognitive impairment or psychiatric disorder that would interfere with completion of the questionnaire or informed consent. 3. Currently participating in another oral health research study. 4. Complete edentulism or extensive fixed prosthetic rehabilitation that precludes assessment of the Decayed, Missing, and Filled Teeth (DMFT) index.

Outcomes

Primary Outcomes

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).