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

Official title

Validation of a Digital Caries Risk Assessment Questionnaire Against the CAMBRA Protocol in an Egyptian Adult Population: A Cross-Sectional Diagnostic Agreement Study

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

• 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 s

Primary outcome measures

• Cohen's weighted kappa [Time frame: Baseline (single study visit)]

Secondary outcome measures (6)

• Diagnostic accuracy of the Digital Caries Risk Questionnaire (DCRQ) for identifying participants with high cumulative caries experience (DMFT ≥ 4). [Time frame: Baseline (single study visit)]
• Discriminative ability of the DCRQ for identifying participants with high cumulative caries experience. [Time frame: Baseline (single study visit)]
• Independent predictors of high cumulative caries experience. [Time frame: Baseline (single study visit)]
• Internal consistency of the DCRQ. [Time frame: Baseline (single study visit)]
• Test-retest reliability of the DCRQ. [Time frame: 14 days after baseline]
• Performance of the DCRQ across participant subgroups. [Time frame: Baseline (single study visit)]

Eligibility criteria

• Inclusion Criteria

• Adults aged 18 to 65 years.
• Egyptian nationals or individuals who have resided in Egypt for at least 5 years.
• Able to read and understand Arabic or English.
• Presence of at least 10 natural teeth.
• Presenting for routine dental examination, preventive care, or treatment planning.
• Able and willing to provide written informed consent.
• Exclusion Criteria

• Presence of acute dental pain or a dental emergency requiring immediate treatment at the time of enrollment.
• Severe cognitive impairment or psychiatric disorder that would interfere with completion of the questionnaire or informed consent.
• Currently participating in another oral health research study.
• Complete edentulism or extensive fixed prosthetic rehabilitation that precludes assessment of the Decayed, Missing, and Filled Teeth (DMFT) index.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Egypt · 1 center

• October University for Modern Sciences and Arts — Giza

Publications

• Featherstone JDB, Chaffee BW. The Evidence for Caries Management by Risk Assessment (CAMBRA(R)). Adv Dent Res. 2018 Feb;29(1):9-14. doi: 10.1177/0022034517736500. PMID 29355423
• Catala-Benavent I, Iranzo-Cortes JE, Almerich-Torres T, Marquez-Arrico CF, Almerich-Silla JM, Montiel-Company JM. Comparative Study of Methods for Caries Risk Evaluation: CAMBRA, the Cariogram, and Caries Risk Semaphore. J Clin Med. 2025 Jul 30;14(15):5378. doi: 10.3390/jcm14155378. PMID 40807000
• Iqbal A, Siddiqui YD, Chaudhary FA, Abideen MZU, Hussain T, Arjumand B, Almuhaiza M, Mustafa M, Khattak O, Attia RM, Rashed AA, Sultan SE. Caries risk assessment by Caries Management by Risk Assessment (CAMBRA) Protocol among the general population of Pakistan-a multicenter analytical study. PeerJ. 2024 Jan 31;12:e16863. doi: 10.7717/peerj.16863. eCollection 2024. PMID 38313036
• Featherstone JDB, Crystal YO, Alston P, Chaffee BW, Domejean S, Rechmann P, Zhan L, Ramos-Gomez F. A Comparison of Four Caries Risk Assessment Methods. Front Oral Health. 2021 Apr 28;2:656558. doi: 10.3389/froh.2021.656558. eCollection 2021. PMID 35048004
• Department of Error. Lancet. 2020 Nov 14;396(10262):1562. doi: 10.1016/S0140-6736(20)32226-1. Epub 2020 Oct 23. No abstract available. PMID 33198906
• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74. PMID 843571
• Flahault A, Cadilhac M, Thomas G. Sample size calculation should be performed for design accuracy in diagnostic test studies. J Clin Epidemiol. 2005 Aug;58(8):859-62. doi: 10.1016/j.jclinepi.2004.12.009. PMID 16018921
• Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527. PMID 26511519

Identifiers

NCT: NCT07716254 · REC-D 12346-6

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗