About this trial
This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. The study will compare questionnaire-based results with clinical examination results to evaluate diagnostic accuracy and agreement.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult aged 18 years or older
Able to read and understand the study information and provide informed consent
Able to complete the online questionnaire independently (on a smartphone/tablet/computer)
Willing to undergo a same-visit clinical periodontal examination
Disqualifiers
Completely edentulous (no natural teeth)
Currently undergoing active periodontal treatment (e.g., scaling and root planing) or received periodontal therapy within the past [6 months]
Took systemic antibiotics within the past [3 months]
Unable to complete the questionnaire or examination due to cognitive impairment, severe illness, or communication barriers that prevent informed consent
Trial population
Participants will be selected from members of the general public who are scheduled for dental screening appointments at Asir Specialized Dental Center, Abha, Saudi Arabia. Recruitment and study procedures will take place at the center during the scheduled screening visit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)
Other interventionParticipants complete an online self-assessment questionnaire and undergo a same-visit clinical periodontal examination to assign a reference-standard periodontal risk category (low/medium/high). No therapeutic intervention is assigned as part of this observational study.
Treatment groups
Trial outcomes
Primary outcomes
Agreement between self-assessment risk category and clinical periodontal risk category
Agreement between the questionnaire-derived periodontal risk category and the reference-standard clinical periodontal risk category assigned during the same visit. Both classifications will use three ordered categories: low risk, medium risk, and high risk. Agreement will be summarized using weighted kappa and the proportion of exact matches. Weighted kappa ranges from -1 to 1, where 1 indicates perfect agreement, 0 indicates agreement equivalent to chance, and values below 0 indicate less agreement than expected by chance.
Overall Diagnostic Accuracy of Self-Assessment Tool for Periodontal Risk Classification
Overall diagnostic accuracy of the questionnaire-derived periodontal risk classification compared with the clinical reference-standard periodontal risk classification. Accuracy will be calculated as the proportion of correctly classified participants among all participants. The value ranges from 0 to 1, where higher values indicate better classification performance.
Sensitivity and Specificity for High-Risk Periodontal Disease Detection
Sensitivity and specificity of the self-assessment questionnaire for identifying high-risk periodontal status compared with the clinical reference-standard classification. High-risk periodontal status will be compared against non-high-risk status, which includes low-risk and medium-risk categories. Sensitivity and specificity each range from 0 to 1, where higher values indicate better diagnostic performance
Macro-Averaged F1-Score for Periodontal Risk Classification
Macro-averaged F1-score across the three periodontal risk categories: low risk, medium risk, and high risk. The F1-score is the harmonic mean of precision and recall, calculated separately for each risk category and then averaged equally across categories. The macro-averaged F1-score ranges from 0 to 1, where higher values indicate better classification performance.
Sponsors and contacts
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