An observational study in Periodontal Diseases, Periodontitis and Gingivitis, sponsored by Universiti Sains Malaysia. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Universiti Sains Malaysia · Observational
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.
Periodontal disease is a common oral health problem that can progress silently and may lead to gum inflammation, tooth loss, and reduced quality of life if not detected and managed early. Many people may not recognize early signs or may delay seeking dental care until symptoms become more noticeable. An online self-assessment tool may help members of the public identify whether they are at higher risk and encourage timely evaluation and preventive care.
This observational study will collect labeled data to evaluate the accuracy of an online periodontal self-assessment tool in the general adult population. Participants will complete a structured online questionnaire that asks about oral and periodontal health symptoms, dental history, oral hygiene practices, and other health-related factors commonly linked to periodontal risk. During the same visit, each participant will undergo a standardized clinical periodontal examination conducted by a trained clinician. The clinical examination will serve as the reference standard to assign a periodontal risk label for each participant, categorized as low, medium, or high risk according to predefined criteria in the study protocol.
The primary purpose of this labeled-data phase is to compare the questionnaire-based assessment with the clinically determined risk level (low/medium/high) to determine how well the self-assessment tool identifies periodontal risk in the general public. Primary analyses will evaluate agreement and accuracy between questionnaire outputs and the clinical reference label (for example, diagnostic accuracy measures and agreement statistics).
This study does not assign any treatment or preventive intervention. Study activities include completion of an online questionnaire and a same-visit periodontal clinical examination. Risks are minimal and may include mild, temporary discomfort or minor bleeding during periodontal probing, as well as potential privacy risks related to collection of questionnaire responses and clinical findings. To protect confidentiality, participants' data will be recorded using a study identifier rather than direct personal identifiers and will be stored in secure, access-controlled systems accessible only to authorized study personnel.
The results of this study are expected to support validation and refinement of the self-assessment tool and inform future efforts to improve early identification of periodontal risk and promote preventive oral health care at the community level.
867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's planned enrollment of 393 is above the median of 99 across 302 observational studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Universiti Sains Malaysia is the lead sponsor of 177 studies on the registry; 51 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
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.
Time frame: Same visit (baseline)
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.
Time frame: Same visit (baseline)
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
Time frame: Same visit (baseline)
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.
Time frame: Same visit (baseline)
Plan to share: Yes — De-identified individual participant data (questionnaire responses, clinically assigned periodontal risk category, and relevant derived variables) will be made available to qualified researchers upon reasonable request and approval by the study team and ethics requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: De-identified IPD and supporting documents will be available beginning 12 months after publication of the primary results (or 12 months after study completion if not published) and will remain available for 5 years thereafter.
Access criteria: Access will be provided to qualified researchers who submit a methodologically sound proposal (protocol/analysis plan) and obtain any required ethics approval/exemption. Approved requestors will receive de-identified participant-level data (questionnaire responses, clinical periodontal risk label [low/medium/high], and derived variables) plus selected supporting documents (protocol, SAP, blank ICF, and analytic code) under a data use agreement. Requests will be reviewed by the study team, and data will be shared via a secure transfer method. No direct identifiers will be shared.
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