Dental CariesNCT07716254
Validation of a Digital Caries Risk Assessment Questionnaire Against the CAMBRA Protocol in an Egyptian Adult Population
An observational study of Dental Caries and Caries Risk, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Caries Risk
- What is being tested?
- Digital Caries Risk Assessment
- Type of treatment
- Pill or oral medicine
- How many people
- 384 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
October University for Modern Sciences and Arts
Giza, Sixth of October, 12566
Shereen Assem El Sherif, Dr., 01066668112, selsherif@msa.edu.eg
About this study
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
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.
- Conditions
- Dental Caries, Caries Risk
- Being tested
- Digital Caries Risk Assessment
- Keywords
- CAMBRA, caries risk assessment, digital health, oral health questionnaire, diagnostic agreement, Egypt, MENA, preventive dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Digital caries risk assessment | Not described Receives: Diagnostic Test: Digital Caries Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (single study visit)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Internal consistency of the DCRQ.
Internal consistency reliability will be assessed using Cronbach's alpha coefficient.
Measured: 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.
Measured: 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.
Measured: Baseline (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start5 Jun 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Assem, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716254
- Sponsor's protocol ID
- REC-D 12346-6
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29355423Catala-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.
PubMed 40807000Iqbal 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.
PubMed 38313036Featherstone 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.
PubMed 35048004Department of Error. Lancet. 2020 Nov 14;396(10262):1562. doi: 10.1016/S0140-6736(20)32226-1. Epub 2020 Oct 23. No abstract available.
PubMed 33198906Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
PubMed 843571Flahault 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.
PubMed 16018921Bossuyt 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.
PubMed 26511519Young DA, Featherstone JD, Roth JR, Anderson M, Autio-Gold J, Christensen GJ, Fontana M, Kutsch VK, Peters MC, Simonsen RJ, Wolff MS. Caries management by risk assessment: implementation guidelines. J Calif Dent Assoc. 2007 Nov;35(11):799-805.
PubMed 18080486
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07716254
- Acronym / sponsor ID
- REC-D 12346-6
- Conditions
- Dental Caries, Caries Risk
- Keywords
- CAMBRA, caries risk assessment, digital health, oral health questionnaire, diagnostic agreement, Egypt, MENA, preventive dentistry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 5 Jun 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital caries risk assessment | – | Diagnostic Test: Digital Caries Risk Assessment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Caries Risk AssessmentThe 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). | Diagnostic test | Digital caries risk assessment |
Primary outcome
Cohen's weighted kappa
Time frame: Baseline (single study visit)
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).
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 29355423Featherstone 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.
- Results publication: PubMed 40807000Catala-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.
- Results publication: PubMed 38313036Iqbal 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.
- Results publication: PubMed 35048004Featherstone 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.
- Results publication: PubMed 33198906Department of Error. Lancet. 2020 Nov 14;396(10262):1562. doi: 10.1016/S0140-6736(20)32226-1. Epub 2020 Oct 23. No abstract available.
- Results publication: PubMed 843571Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.
- Results publication: PubMed 16018921Flahault 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.
- Results publication: PubMed 26511519Bossuyt 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.
- Results publication: PubMed 18080486Young DA, Featherstone JD, Roth JR, Anderson M, Autio-Gold J, Christensen GJ, Fontana M, Kutsch VK, Peters MC, Simonsen RJ, Wolff MS. Caries management by risk assessment: implementation guidelines. J Calif Dent Assoc. 2007 Nov;35(11):799-805.
- GSMA Intelligence. The Mobile Economy: Middle East and North Africa 2023. London: GSMA Intelligence; 2023.Link provided by the sponsor.
- Basic oral health surveys provide a sound basis for assessing the current oral health status of a population and its future needs for oral health care. The World Health Organization (WHO) has a long tradition of epidemiological survey methodologyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and Caries Risk, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shereen Assem El Sherif, Dr. (+201066668112, selsherif@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohen's weighted kappa (time frame: Baseline (single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07716254, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.