NCT07716254 Validation of a Digital Caries Risk Assessment Questionnaire Against the CAMBRA Protocol in an Egyptian Adult Population
| NCT ID | NCT07716254 |
| Status | Recruiting |
| Phase | — |
| Sponsor | October University for Modern Sciences and Arts |
| Condition | Dental Caries |
| Study Type | OBSERVATIONAL |
| Enrollment | 384 participants |
| Start Date | 2026-06-05 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 384 participants in total. It began in 2026-06-05 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
* 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07716254 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Dental Caries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07716254 currently recruiting?
Yes, NCT07716254 is actively recruiting participants. Contact the research team at selsherif@msa.edu.eg for enrollment information.
Where is the NCT07716254 trial being conducted?
This trial is being conducted at Giza, Egypt.
Who is sponsoring the NCT07716254 clinical trial?
NCT07716254 is sponsored by October University for Modern Sciences and Arts. The trial plans to enroll 384 participants.