Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning

Development and Validation of a Self-assessment Tool for Periodontal Disease Risk Assess Among the Saudi Population Using Semi-supervised Learning

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Periodontal Diseases; Gingivitis
• Intervention / Treatment: Other: Online periodontal self-assessment questionnaire and clinical periodontal examination (reference standard)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 393

Contacts and Locations

• Study Contact: Name: Abdulrahman Ahmed Alshehri, MS; Phone Number: 00966507090251; Email: alshehriabdulrahman3@student.usm.my

Study Locations

• Saudi Arabia
  • 'Asir Region
    • Abhā, 'Asir Region, Saudi Arabia
      • Recruiting
      • Abha Specialized Dental Center
      • Contact: Abdulrahman Alshehri, BDS, MS; Phone Number: 00966507090251; Email: alshehriabdulrahman3@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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
• Has natural teeth present (dentate)

Exclusion Criteria:

• 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
• Refuses or is unable to tolerate the periodontal clinical examination

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	Same visit (baseline)

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Abdulrahman Ahmed Alshehri, MS, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: January 31, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: risk assessment; Periodontal diseases; self-report
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontitis; Periodontal Diseases; Gingivitis; Investigative Techniques; Weights and Measures; Reference Standards
• Other Study ID Numbers: USM/JEPeM/KK/25050469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No